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An important cause of stunting is limited consumption of complementary foods, in terms of both quantities and nutrients. Although existing studies show a positive association between fathers' engagement and children's diet, programmes designed to improve complementary feeding practices often only target mothers. In response to this, maternal behaviour change communication (BCC), paternal BCC and food voucher programmes were designed and implemented in Ethiopia using a clustered randomized controlled trial design. The paternal BCC programme included gender‐equal messages to increase fathers' participation in childcare, household labour and decision making. The research reported in this paper is an examination of the BCC programmes, characterizing the behavioural, normative and control beliefs of both mothers and fathers in BCC households compared to those in control households. In this study, a total of 40 participants were included, with 13 mother–father pairs in the BCC + food voucher group, and seven pairs in the control group. Each participant was interviewed separately. We found that BCC mothers showed more gender‐equal tendencies than the control mothers despite being more rural in location. By contrast, the beliefs of BCC and control fathers were similar overall, suggesting men are more resistant to gender‐equal BCC. More work is needed to develop and test effective methods for changing fathers' beliefs and practices. Key messages: Mothers in behaviour change communication (BCC) group mothers held more gender‐equal beliefs than control mothers, while BCC and control fathers shared similar views, suggesting a male resistance to gender equality.Mothers found fathers' involvement in childcare socially acceptable but often perceived them as inexperienced, which limited their participation.Control mothers' traditional view on household chores maintained the conventional labour division, influencing fathers' involvement.Fathers typically resisted maternal control of resources; however, they agreed that the more knowledgeable should lead decision‐making. BCC mothers showed greater confidence in making household decisions as effectively as fathers. [ABSTRACT FROM AUTHOR]

Objective: To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology.Methods: A randomized controlled efficacy study of three 6-month weight loss treatments was conducted in 96 adults with obesity: 1) self-guided (SELF), 2) standard (STND), or 3) technology-supported (TECH). STND and TECH received eight in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, activity, and weight; TECH used a smartphone application with social networking features and wireless accelerometer.Results: Weight loss was greater for TECH and STND than SELF at 6 months (-5.7 kg [95% confidence interval: -7.2 to -4.1] vs. -2.7 kg [95% confidence interval: -5.1 to -0.3], P < 0.05) but not 12 months. TECH and STND did not differ except that more STND (59%) than TECH (34%) achieved ≥ 5% weight loss at 6 months (P < 0.05). Self-monitoring adherence was greater in TECH than STND (P < 0.001), greater in both interventions than SELF (P < 0.001), and covaried with weight loss (r(84) = 0.36-0.51, P < 0.001).Conclusions: Abbreviated behavioral counseling can produce clinically meaningful weight loss regardless of whether self-monitoring is performed on paper or smartphone, but long-term superiority over standard of care self-guided treatment is challenging to maintain. [ABSTRACT FROM AUTHOR]

Background: Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co‐designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient‐held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. Design: Twenty one‐to‐one semi‐structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co‐analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. Results: Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. Conclusion: Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. Patient or Public Contribution: Patients were involved in the study design, as qualitative data co‐analysts and as co‐authors. [ABSTRACT FROM AUTHOR]

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Aims: Patients surviving an acute myocardial infarction (AMI) are at risk of developing symptomatic heart failure (HF) or premature death. We hypothesized that sacubitril/valsartan, effective in the treatment of chronic HF, prevents development of HF and reduces cardiovascular death following high-risk AMI compared to a proven angiotensin-converting enzyme (ACE) inhibitor. This paper describes the study design and baseline characteristics of patients enrolled in the Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI) trial.Methods and Results: PARADISE-MI, a multinational (41 countries), double-blind, active-controlled trial, randomized patients within 0.5-7 days of presentation with index AMI to sacubitril/valsartan or ramipril. Transient pulmonary congestion and/or left ventricular ejection fraction (LVEF) ≤40% and at least one additional factor augmenting risk of HF or death (age ≥70 years, estimated glomerular filtration rate <60 mL/min/1.73 m2 , diabetes, prior myocardial infarction, atrial fibrillation, LVEF <30%, Killip class ≥III, ST-elevation myocardial infarction without reperfusion) were required for inclusion. PARADISE-MI was event-driven targeting 708 primary endpoints (cardiovascular death, HF hospitalization or outpatient development of HF). Randomization of 5669 patients occurred 4.3 ± 1.8 days from presentation with index AMI. The mean age was 64 ± 12 years, 24% were women. The majority (76%) qualified with ST-segment elevation myocardial infarction; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%. LVEF was 37 ± 9% and 58% were in Killip class ≥II.Conclusions: Baseline therapies in PARADISE-MI reflect advances in contemporary evidence-based care. With enrollment complete PARADISE-MI is poised to determine whether sacubitril/valsartan is more effective than a proven ACE inhibitor in preventing development of HF and cardiovascular death following AMI. [ABSTRACT FROM AUTHOR]

Good nutrition in the early years of life is vitally important for a child's development, growth and health. Children's diets in the United Kingdom are known to be poor, particularly among socially disadvantaged groups, and there is a need for timely and appropriate interventions that support parents to improve the diets of young children. The Medical Research Council has highlighted the importance of conducting developmental and exploratory research prior to undertaking full-scale trials to evaluate complex interventions, but have provided very limited detailed guidance on the conduct of these initial phases of research. This paper describes the initial developmental stage and the conduct of an exploratory randomised controlled trial undertaken to determine the feasibility and acceptability of a family-centred early years' nutrition intervention. Choosing Healthy Eating when Really Young ( CHERRY) is a programme for families with children aged 18 months to 5 years, delivered in children's centres in one urban ( Islington) and one rural ( Cornwall) location in the United Kingdom. In the development stage, a mixed-methods approach was used to investigate the nature of the problem and options for support. A detailed review of the evidence informed the theoretical basis of the study and the creation of a logic model. In the feasibility and pilot testing stage of the exploratory trial, 16 children's centres, with a sample of 394 families were recruited onto the study. We hope that the methodology, which we present in this paper, will inform and assist other researchers in conducting community-based, exploratory nutrition research in early years settings. [ABSTRACT FROM AUTHOR]

Aim: To examine the efficacy of Hand-Arm Bimanual Intensive Therapy (HABIT) on daily functioning, unimanual dexterity, and bimanual performance of children with bilateral cerebral palsy (CP) compared with customary care.Method: Forty-one children with bilateral CP, aged 4 to 16 years, classified in levels I to III of the Manual Ability Classification System, were randomly assigned to HABIT (90h) (n=21) or to customary care (4.5h) (n=20). Participants' daily functioning (Pediatric Evaluation of Disability Inventory [PEDI], Canadian Occupational Performance Measure [COPM]), unimanual dexterity (Jebsen-Taylor Test of Hand Function, Box and Blocks Test [BBT]), and bimanual performance (Both Hands Assessment) were assessed pre-, post-, and 6 months after the intervention. Linear mixed-effects models were used for inferential analysis.Results: Children participating in HABIT showed greater improvements in daily functioning (COPMperformance : χ12 =9.50, p<0.01; COPMsatisfaction : χ12 =5.07, p<0.05; PEDIfunctional skills : χ12 =6.81, p<0.01; PEDIcaregiver assistance : χ12 =6.23, p<0.05) and in the dexterity of the dominant hand (BBT: χ12 =3.99, p<0.05) compared with children maintaining customary care. Group or time effects did not explain any variance in bimanual performance or in the dexterity of the non-dominant hand.Interpretation: HABIT may be beneficial for children with bilateral CP, with benefits evidenced for daily functioning outcomes.What This Paper Adds: Hand-Arm Bimanual Intensive Therapy (HABIT) improved daily functioning of children with bilateral cerebral palsy (CP). Bimanual performance, measured by the Both Hands Assessment, did not change after HABIT in children with bilateral CP. Children with asymmetric and symmetric hand use exhibited similar improvements after HABIT. [ABSTRACT FROM AUTHOR]

Aim: To evaluate safety and motor function after treatment with allogeneic umbilical cord blood (AlloCB) or umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy (CP).Method: Ninety-one children (52 males, 39 females; median age 3 years 7 months [range 2-5 years]) with CP due to hypoxic-ischemic encephalopathy, stroke, or periventricular leukomalacia were randomized to three arms: (1) the AlloCB group received 10 × 107 AlloCB total nucleated cells (TNC) per kilogram at baseline (n = 31); (2) the hCT-MSC group received 2 × 106 hCT-MSC at baseline, 3 months, and 6 months (n = 28); (3) the natural history control group received 10 × 107 AlloCB TNC per kilogram at 12 months (n = 31). Motor function was assessed with the Gross Motor Function Measure-66 (GMFM-66) and Peabody Developmental Motor Scale, Second Edition.Results: Infusions (n = 143) were well tolerated, with eight infusion reactions (three in the AlloCB group, five in hCT-MSC) and no other safety concerns. At 12 months, the mean differences (95% confidence intervals [CI]) between actual and expected changes in GMFM-66 score were AlloCB 5.8 points (3.4-8.2), hCT-MSC 4.3 (2.2-6.4), and natural history 3.1 (1.4-5.0). In exploratory, post hoc analysis, the mean GMFM-66 score (95% CI) of the hCT-MSC group was 1.4 points higher than natural history (-1.1 to 4.0; p = 0.27), and the AlloCB group was 3.3 points higher than natural history (0.59-5.93; p = 0.02) after adjustment for baseline Gross Motor Function Classification System level, GMFM-66 score, and etiology.Interpretation: High-dose AlloCB is a potential cell therapy for CP and should be further tested in a randomized, blinded, placebo-controlled trial.What This Paper Adds: Unrelated donor allogeneic umbilical cord blood (AlloCB) and human umbilical cord tissue-derived mesenchymal stromal cell infusion is safe in young children with cerebral palsy. Significant changes in motor function were not observed 6 months after treatment. One year later, treatment with AlloCB was associated with greater increases in Gross Motor Function Measure-66 scores. [ABSTRACT FROM AUTHOR]

Backgroud: Discharge planning from the hospital of frail older patients is an important step to avoid inappropriate long‐stay hospitalizations and to prevent the risks related to the prolonged hospitalization. In this frame, we developed an experimental trial—'PRO‐HOME', a multicomponent programme of interventions for multimorbid and polytreated hospitalized older patients. Aim: The main aim of the study was to develop a protected discharge facility using a mini apartment equipped with advanced architectural and technological components to reduce the length of hospital stay of older participants (aged 65+ years old) admitted to the hospital for an acute event, deemed stable and dischargeable. Materials and Methods: This is a pilot randomized controlled study, comparing 30 hospitalized participants included in a multidimensional, transitional care programme based on information and communication technologies to 30 patients in standard usual care until hospital discharge. Results: We presented the study design of the PRO‐HOME programme, including architectural and technological components, the enrolment procedures, the components of the intervention that is physical activity, cognitive training and life‐style education and the evaluation method of the intervention based on the Comprehensive Geriatric Assessment to explore the changes in the individual domains that are target of the multicomponent intervention. Conclusions: The final results will suggest whether the PRO‐HOME programme represents a useful and feasible intervention to reduce the length of hospital stay of multimorbid and polytreated hospitalized older patients and improve their physical and cognitive performances and overall quality of life. Patient or Public Contribution: Due to the characteristics of the population of interest of the PRO‐HOME study, we involved in the study design and programme of the activities the participants enrolled in a previous smart home‐based project named MoDiPro carried‐out during a 3‐year period. The elderly participants from the local population involved were asked, by means of focus groups, for feedback on their experience in MoDiPro, and their suggestions were integrated into the design phase of the current PRO‐HOME project. The focus groups included open group interviews with a qualitative collection of the patients' feedback so that the participants could interact with each other. [ABSTRACT FROM AUTHOR]

Objective Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs). Methods We developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not improved over a period of 1 year. Using the profiles for which raters had reached a consensus on whether the patients were improved versus not improved (79% of the profiles examined), we fit logistic regression models in which the binary outcome referred to whether the patient was improved or not, and the changes in the core set items from baseline to followup were entered as covariates. We tested the final index in a previously completed RCT. Results Sixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. In the logistic regression model in which the included core set items were change over 1 year in the modified Rodnan skin thickness score, the forced vital capacity, the patient and physician global assessments, and the Health Assessment Questionnaire disability index, sensitivity was 0.982 (95% confidence interval 0.982-0.983) and specificity was 0.931 (95% confidence interval 0.930-0.932), and the model with these 5 items had the highest face validity. Subjects with a significant worsening of renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. With use of the index, the effect of methotrexate could be differentiated from the effect of placebo in a 1-year RCT ( P = 0.02). Conclusion We have developed a CRISS that is appropriate for use as an outcome assessment in RCTs of early dcSSc. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the impact of sub epidermal moisture (SEM) measurement and targeted pressure ulcer (PU) prevention, versus visual skin assessment and usual care, on mean SEM delta scores and early pressure ulcer development in acute hospital patients. A quantitative quasi‐experimental observational approach was used. A total of 149 at risk acute hospital patients took part, 78 treatment, and 71 control. SEM deltas were recorded daily for a maximum of 5 days using the SEM Scanner (Bruin Biometrics LLC, Los Angeles, California), on three sites: the sacrum, the right heel, and the left heel, with enhanced and targeted PU prevention interventions occurring in those with an elevated SEM delta scores in the treatment group. Intention to treat analysis was used to guide the final composition of results. SEM PU represents PU development as identified by 2 days of sustained abnormal SEM delta scores, ≥0.5, after day one. The mean number of days completed by participants was just under 4 days, participants had many different comorbidities, with the most common being: hypertension, cancer, and chronic obstructive pulmonary disease. Results showed that following the introduction of SEM guided targeted treatments, participants in the treatment group yielded a statistically significant reduction in mean SEM delta scores (MD: 0.49; 95% CI: 0.59, 0.39; P <.0001), and in the odds of developing a SEM PU (OR: 0.59, 95% CI: 0.24 to 1.00; P =.05). In the treatment group, none of the participants developed a visual PU, whereas, in the control group, 1.41% (n = 1/71) developed a visual PU. Based on all the results, the following is concluded, (1). There was a greater reduction in mean SEM delta scores among those cared for using SEM measurement and targeted PU prevention, versus those cared for using visual skin assessment and usual care, and (2). the mean SEM delta scores was statistically significantly lower at the study end for those who received targeted treatments based on abnormal SEM scores. More research is now needed in other and larger at‐risk groups to further validate what was found in this study. [ABSTRACT FROM AUTHOR]

Nutrition‐sensitive agriculture (NSA) interventions offer a means to improve the dietary quality of rural, undernourished populations. Their effectiveness could be further increased by understanding how household dynamics enable or inhibit the uptake of NSA behaviours. We used a convergent parallel mixed‐methods design to describe the links between household dynamics—specifically intrahousehold power inequalities and intrahousehold cooperation—and dietary quality and to explore whether household dynamics mediated or modified the effects of NSA interventions tested in a cluster‐randomized trial, Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN). We use quantitative data from cross‐sectional surveys in 148 village clusters at UPAVAN's baseline and 32 months afterwards (endline), and qualitative data from family case studies and focus group discussions with intervention participants and facilitators. We found that households cooperated to grow and buy nutritious foods, and gendered power inequalities were associated with women's dietary quality, but cooperation and women's use of power was inhibited by several interlinked factors. UPAVAN interventions were more successful in more supportive, cooperative households, and in some cases, the interventions increased women's decision‐making power. However, women's decisions to enter into negotiations with family members depended on whether women deemed the practices promoted by UPAVAN interventions to be feasible, as well as women's confidence and previous cultivation success. We conclude that interventions may be more effective if they can elicit cooperation from the whole household. This will require a move towards more family‐centric intervention models that empower women while involving other family members and accounting for the varied ways that families cooperate and negotiate. Key messages: Household cooperation and intrahousehold power inequalities may influence children's and mothers' dietary diversity in rural OdishaThese factors partly determine the effects of nutrition‐sensitive agriculture (NSA) interventions tested in Upscaling Participatory Action and Videos for Agriculture and Nutrition, indicating that NSA interventions may be more effective if they include multiple family members.There is wide heterogeneity in household dynamics and the constraints that families face. Further research is needed to identify how interventions can respond to this heterogeneity so that NSA interventions are effective in an inclusive and empowering way. [ABSTRACT FROM AUTHOR]

Objective: Despite the high prevalence of obesity and associated health risks in the United States adult population, few primary care providers (PCPs) have time and training to provide weight-management counseling to their patients. This study aims to compare the effect of referral to a comprehensive automated digital weight-loss program, with or without provider email feedback, with usual care on weight loss in patients with overweight or obesity.Methods: A total of 550 adults (mean [SD], 51.4 [11.2] years, BMI = 35.1 [5.5] kg/m2 , 72.0% female) were enrolled through their PCPs (n = 31). Providers were randomly assigned to refer their patients to a 12-month internet weight-loss intervention only (IWL), the intervention plus semiautomated feedback from the provider (IWL + PCP), or to usual care (EUC). Weight was measured at baseline and at 3, 6, and 12 months.Results: Weight changes (mean [SE]) at 12 months were -0.92 (0.46), -3.68 (0.46), and -3.58 (0.48) kg in the EUC, IWL, and IWL + PCP groups, respectively. Outcomes were significantly different in EUC versus IWL and EUC versus IWL + PCP (p < 0.001), but not in IWL versus IWL + PCP.Conclusions: Referral by PCPs to an automated weight-loss program holds promise for patients with obesity. Future research should explore ways to further promote accountability and adherence. [ABSTRACT FROM AUTHOR]

Objective: The postpartum period is a key life stage, contributing to increased maternal obesity risk. Current lifestyle interventions do not consider the role of a woman's partner in reducing stress and supporting lifestyle change. The objective of this study was to assess the effect of an intervention that seeks to enhance coparenting relationship quality on maternal BMI from before conception to 12 months post partum and whether the intervention moderated the association of changes in cortisol and BMI.Methods: A randomized controlled trial was used to assess an intervention (eight classes: four during and four following pregnancy) focusing on enhancing couple coparenting relationships during pregnancy and post partum (n = 57) compared with standard care (n = 53).Results: The main outcome measures were changes in maternal BMI and cortisol. There was a smaller increase in BMI for mothers in intervention compared with control groups (mean [SE], -1.03 [0.42] kg/m2 , p = 0.015). There was an interaction between intervention status and cortisol change predicting BMI change (p = 0.026), such that cortisol change significantly predicted BMI change among mothers in the control (p = 0.049) but not the intervention groups (p = 0.204).Conclusions: A coparenting intervention improved maternal postpartum BMI, with this effect potentially related to ameliorating the negative effect of stress, as measured by cortisol, on BMI. The role of enhanced coparenting in improving maternal anthropometry warrants urgent attention. [ABSTRACT FROM AUTHOR]

Child undernutrition in Cambodia is a persistent public health problem requiring low‐cost and scalable solutions. Rising cellphone use in low‐resource settings represents an opportunity to replace in‐person counselling visits with phone calls; however, questions remain on relative effectiveness. Our objective was to evaluate the impact of two options for delivering a World Vision infant and young child feeding (IYCF) counselling programme: (1) traditional Positive Deviance/Hearth (PDH) programme with in‐person visits or (2) PDH with Interactive Voice Calling (PDH‐IVC) which integrates phone calls to replace 62.5% of face‐to‐face interaction between caregivers and volunteers, compared to the standard of care (SOC). We conducted a longitudinal cluster‐randomised controlled trial in 361 children 6–23 months. We used an adjusted difference‐in‐difference approach using baseline, midline (3 months) and endline (12 months) surveys to evaluate the impact on child growth among the three groups. At baseline, nearly a third of children were underweight, and over half were food insecure. At midline the PDH group and the PDH‐IVC groups had improved weight‐for‐age z‐scores (0.13 DID, p = 0.011; 0.13 DID, p = 0.02, respectively) and weight‐for‐height z‐score (0.16 DID, p = 0.038; 0.24 DID, p = 0.002), relative to SOC. There were no differences in child height‐for‐age z‐scores. At endline, the impact was sustained only in the PDH‐IVC group for weight‐for‐age z‐score (0.14 DID, p = 0.049), and the prevalence of underweight declined by 12.8 percentage points (p = 0.036), relative to SOC. Integration of phone‐based IYCF counselling is a potentially promising solution to reduce the burden of in‐person visits; however, the modest improvements suggest the need to combine it with other strategies to improve child nutrition. [ABSTRACT FROM AUTHOR]

Background: The Assessing outcomes of enhanced Chronic disease Care through patient Education and a value‐baSed formulary Study (ACCESS) is a randomized controlled trial evaluating two interventions targeting barriers to care among those at high risk of cardiovascular disease: copayment elimination for cardioprotective medications, and a tailored self‐management support programme. We designed a process evaluation to better understand participant perspectives on the interventions. Design: We used a qualitative descriptive study design, collecting patient and pharmacist feedback via individual semi‐structured telephone interviews and in‐person focus groups. Data were analysed inductively using thematic analysis. Results: Fifty‐three patients (39 interviews and 14 in two focus groups) and 20 pharmacists participated. Copayment elimination provided quality of life benefits: minimizing the need to 'cut‐back', allowing 'peace of mind' and providing emotional support. Health‐related benefits included: improving adherence to covered medications, and helping to afford non‐covered goods. The only criticism was that not all medications and testing supplies were covered. Patients reported that the educational materials provided helpful information, acted as a reminder, improved confidence, improved adherence to medication, and helped initiate conversations with providers about indicated medication. Some participants felt that the educational materials were repetitive, overly medication‐focused and not tailored enough. Pharmacists felt that their patients benefitted from both interventions, which improved patient adherence and communication with their patients. Conclusion: The success of interventions intended to change behaviour is largely dependent upon participant's feelings that the intervention is helpful. This process evaluation provided insights into participants' perceptions on these interventions. Reception of both was largely positive with a few criticisms noted. [ABSTRACT FROM AUTHOR]

Objective: Weight stigma is associated with poor dietary adherence, yet adherence is essential for weight loss and maintenance. This study aimed to determine differences in dietary adherence and perceived hunger between lean individuals and two groups of individuals with obesity.Methods: In a 6-week outpatient dietary intervention (23 males; aged 48  [SD 14] years), lean participants (n = 23; BMI 23  [SD 2] kg/m2 ) received a weight-maintaining energy needs (WMEN) diet, and participants with obesity (BMI 36  [SD 7]) were randomized to either WMEN (n = 18) or a 35% calorie-reduced (CR) diet (n = 19). All food was provided, and multiple adherence and hunger ratings were assessed daily and weekly on an outpatient basis and in person at twice-weekly visits (e.g., 24-hour recall, diaries).Results: Weight decreased more in the group of CR individuals with obesity (β = -0.301 kg/wk, P = 0.02) compared with the group of lean individuals and the group of WMEN individuals with obesity. However, total percent adherence did not differ between groups (P = 0.60), and hunger scores did not change across groups over time (P = 0.08).Conclusions: Results indicate that there are no differences in dietary adherence between lean individuals and individuals with obesity and adherence is not associated with adiposity or hunger. Thus, the belief that nonadherence (e.g., lack of willpower) is unique to obesity is untrue and may perpetuate weight bias and stigma. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to determine whether suppression of ovarian function (gonadotropin-releasing hormone agonist [GnRHAG ]) for 24 weeks in premenopausal women approaching menopause causes changes in body composition and a decline in free-living physical activity energy expenditure (PAEE) and whether endurance exercise training attenuates the changes.Methods: Premenopausal women who were approaching menopause (mean [SD]: age 46 [3] years, BMI 26.3 [4.8] kg/m2 ) were randomized to 24 weeks of GnRHAG (n = 14), GnRHAG  + Exercise (n = 11), or placebo (n = 9). Endurance exercise was performed 4 days per week with the goal of expending 200 to 300 kcal per session. Primary outcome measurements included body composition by dual-energy x-ray absorptiometry, total daily energy expenditure (TDEE), and PAEE by doubly labeled water, and resting energy expenditure (REE) by indirect calorimetry.Results: Changes in TDEE, PAEE, REE, or body composition were not different between groups. However, within the GnRHAG group, fat mass increased (mean [SE]: total 1.7 [0.4] kg, trunk 0.9 [0.2] kg, leg 0.6 [0.2] kg) and fat-free leg mass decreased (mean [SE]: -0.4 [0.2] kg) significantly.Conclusions: In premenopausal women approaching menopause, ovarian hormone suppression resulted in increased adiposity without alterations in TDEE, PAEE, or REE. [ABSTRACT FROM AUTHOR]

Background: Person‐centred care (PCC) has been suggested as a potential means to improve the care of patients with chronic and long‐term disorders. In this regard, a model for PCC was developed by the University of Gothenburg Centre for Person‐Centred Care (GPCC). Objective: The present study aimed to explore the theoretical frameworks, designs, contexts and intervention characteristics in the first 27 interventional studies conducted based on the ethics for person‐centredness provided by the GPCC. Design: Cross‐sectional study. Setting and participants: A questionnaire to the principal investigators of the 27 intervention studies financed by the GPCC and conducted between 2010 and 2016. Main outcome measures: Theoretical frameworks, contexts of studies, person‐centred ethic, and outcome measures. Results: Most of the interventions were based on the same ethical assumptions for person‐centredness but theories and models in applying the interventions differed. All studies were controlled; 12 randomized and 15 quasi‐experimental. Hospital in‐ and outpatient and primary care settings were represented and the outcome measures were related to the specific theories used. A complexity in designing, introducing and evaluating PCC interventions was evident. Conclusion: The frameworks, designs and interventions in the studies were in line with the established ethical basis of PCC, whereas outcome measures varied widely. Consensus discussions among researchers in the field are needed to make comparisons between studies feasible. Patient or public contributions: Patients or the public made no direct contributions, although most of the studied projects included such initiatives. [ABSTRACT FROM AUTHOR]

Background: To evaluate the efficacy of synbiotic tablets on the clinical and biochemical parameters of smokers and non-smokers with gingivitis.Methods: Eighty patients with gingivitis [40 smokers (+), 40 non-smokers (-)] were randomly assigned to test (T) or control (C) groups. Four groups were defined: T(+), T(-), C(+) and C(-). The subjects daily chewed a synbiotic or placebo tablet for 30 days. The gingival crevicular fluid levels of interleukin (IL)-6, IL-8 and IL-10 were determined as the primary outcome variables.Results: The clinical and biochemical parameters for all groups significantly reduced compared with the baseline (P < 0.05). While there were no significant differences between the groups for gingival index, the plaque index was significantly higher in both smoker groups than that in the T(-) group during the second month (P < 0.05). IL-8 levels in C(-) and IL-6 levels in both control groups were significantly higher than those in the T(+) group. The IL-10 levels in both control groups were significantly higher than those in the T(-) group during the second month (P < 0.05).Conclusions: Adjunctive synbiotic tablets significantly reduce subclinical therapeutic outcomes for both smokers and non-smokers compared with placebo according to the biochemical parameters. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to compare changes in body fat percentage (BFP), weight, and BMI between a standard intervention and a nutrigenomics intervention.Methods: The Nutrigenomics, Overweight/Obesity and Weight Management (NOW) trial is a parallel-group, pragmatic, randomized controlled clinical trial incorporated into the Group Lifestyle BalanceTM (GLB) Program. Statistical analyses included two-way ANOVA and split-plot ANOVA. Inclusion criteria consisted of: BMI ≥ 25.0 kg/m2 , ≥18 years of age, English speaking, willing to undergo genetic testing, having internet access, and not seeing another health care provider for weight-loss advice outside of the study. Pregnancy and lactation were exclusion criteria. GLB groups were randomly assigned 1 to 1 (N = 140) so that participants received either the standard 12-month GLB program or a modified 12-month program (GLB plus nutrigenomics), which included the provision of nutrigenomics information and advice for weight management. The primary outcome was percent change in BFP. Secondary outcomes were change in weight and BMI.Results: The GLB plus nutrigenomics group experienced significantly (P < 0.05) greater reductions in percent and absolute BFP at the 3-month follow-up and percent BFP at the 6-month follow-up compared with the standard GLB group.Conclusions: The nutrigenomics intervention used in the NOW trial can optimize change in body composition up to 6 months. [ABSTRACT FROM AUTHOR]

The caregiver–child interaction during mealtime, which refers to responsive feeding (RF), influences child's dietary intake. In Cambodia, given the level of malnutrition, getting better knowledge of RF among young children is essential, but to do so, using an appropriate assessment tool is necessary. We aim to develop and to validate a measurement tool to assess RF in two different situations (before and after an intervention) among children 6–23 months old. This research is part of a larger trial assessing the impact of nutrition education combined or not with the provision of complementary foods on child nutritional status. The "Opportunistic Observation Form" from the Process for the Promotion of Child Feeding package was used to collect data on RF through direct observations of child's meal episodes. Data were used to define an initial scale composed of four constructs and 15 indicators. Confirmatory factor analyses (CFA) and Hancock and Mueller's H reliability indices were computed to assess the validity and reliability of the scale. The final tool was applied to baseline and endline data. At baseline, the sample included 243 pairs and, at endline, 248 pairs. The final scale included two latent constructs (RF and active feeding) that comprise three indicators for active feeding and five for RF. Criteria for fit indices of CFA were met for both constructs though better at baseline. Reliability coefficients were above 0.80 for each construct at baseline and endline. This research proposes a scale that could be used to assess active feeding and RF. Further validation is warranted in different contexts. [ABSTRACT FROM AUTHOR]

Aims: Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx.Methods: A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years.Conclusion: The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to investigate whether the intake of the 1975 Japanese diet (JD) could reduce the amount of abdominal fat in people with overweight.Methods: Using a single-blind randomized controlled trial, the modern diet (MD) was compared with the 1975-type JD, which is based on the MD but includes five characteristics of the 1975 JD in an enhanced form. Overweight people were randomly assigned to an MD group (n = 30) and a JD group (n = 30). The participants consumed test diets that were provided three times a day for 28 days. Body composition measurements and blood biochemical examinations were performed before and after the test diet intake, and the proportions of change were compared.Results: Those in the JD group had significantly decreased BMI, fat mass, and levels of low-density lipoprotein cholesterol, glycated hemoglobin, and C-reactive protein (P = 0.002, 0.015, 0.014, 0.012, and 0.039, respectively) and significantly increased high-density lipoprotein cholesterol levels compared with those in the MD group (P = 0.020).Conclusions: The intake of a diet with the characteristics of the 1975 JD may have beneficial effects on lipid metabolism in people with overweight and reduce the onset risk of metabolism-related disorders, such as obesity and diabetes. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the effects of sustained morning fasting or breakfast consumption on metabolism, energy intake, and appetite in healthy adults with obesity.Methods: An independent-measures randomized controlled trial with baseline and follow-up laboratory assessment days separated by a 6-week intervention of either morning fasting (0 kcal until 12:00 pm) or daily breakfast (> 700 kcal by 11:00 am) was performed. Measures included metabolic outcomes (glucose, insulin, nonesterified fatty acids), hormones regulating appetite (total/acylated ghrelin, peptide YY, leptin), and energy expenditure (diet-induced thermogenesis) parameters throughout a laboratory test day and ad libitum intake following a fixed breakfast.Results: Allocation to fasting versus breakfast resulted in minimal adaptation as reflected by the metabolic outcomes or the majority of appetite regulatory outcomes for either area under curve or time-course-based measures (P > 0.05). Ad libitum lunch intake was not different (P = 0.13), nor was diet-induced thermogenesis or a composite appetite score (both P > 0.10). However, there was a reduced total area under the curve for peptide YY (P = 0.05) and increased postprandial hunger ratings (P = 0.05) in the breakfast group.Conclusions: There was little evidence of metabolic adaptation to acute feeding or negative consequences from sustained morning fasting. This indicates that previously observed differences between breakfast consumers and skippers may be acute effects of feeding or may have resulted from other lifestyle factors. [ABSTRACT FROM AUTHOR]

Objective: The Centers for Medicare and Medicaid Services (CMS) covers intensive behavioral therapy (IBT) for obesity. The efficacy, however, of the specific approach has never been evaluated in a randomized trial, as described here. The 1-year trial also assessed whether the addition to IBT of liraglutide 3.0 mg would significantly increase weight loss and whether the provision of meal replacements would add further benefit.Methods: A total of 150 adults with obesity were randomly assigned to: IBT (IBT-alone), providing 21 counseling visits; IBT combined with liraglutide (IBT-liraglutide); or IBT-liraglutide combined for 12 weeks with a 1,000- to 1,200-kcal/d meal-replacement diet (Multicomponent). All participants received weekly IBT visits in month 1, every-other-week visits in months 2 to 6, and monthly sessions thereafter.Results: Ninety-one percent of participants completed 1 year, at which time mean (± SEM) losses for IBT-alone, IBT-liraglutide, and Muticomponent participants were 6.1 ± 1.3%, 11.5 ± 1.3%, and 11.8 ± 1.3% of baseline weight, respectively. Fully 44.0%, 70.0%, and 74.0% of these participants lost ≥ 5% of weight, respectively. The liraglutide-treated groups were superior to IBT-alone on both outcomes. Weight loss in all three groups was associated with clinically meaningful improvements in cardiometabolic risk factors.Conclusions: The findings demonstrate the efficacy of IBT for obesity and the potential benefit of adding pharmacotherapy to this approach. [ABSTRACT FROM AUTHOR]

Objective: To describe a new Veterans Health Administration (VHA) program to foster the learning health system paradigm by rigorously evaluating health care initiatives and to report key lessons learned in designing those evaluations.Principal Findings: The VHA's Quality Enhancement Research Initiative and its Health Services Research and Development Service are cooperating on several large, randomized program evaluations aimed at improving the care veterans receive and the efficiency with which it is delivered. The evaluations we describe involve collaborative design, outcomes assessment, and implementation science through partnerships between VHA operations and researchers. We review key factors to assess before committing to an evaluation. In addition to traditional design issues (such as ensuring adequate power and availability of data), these include others that are easily overlooked: the stability of intervention financing, means of controlling and commitment to adhering to randomized roll-out, degree of buy-in from key implementation staff, and feasibility of managing multiple veto points for interventions that span several programs, among others.Conclusions: Successful program implementation and rigorous evaluation require resources, specialized expertise, and careful planning. If the learning health system model is to be sustained, organizations will need dedicated programs to prioritize resources and continuously adapt evaluation designs. [ABSTRACT FROM AUTHOR]

Aims: A network meta-analysis (NMA) of all recommended drug groups for the treatment of heart failure with reduced ejection fraction (HFrEF), including their combinations, was performed to assess the relative efficacy and incremental benefit.Methods and Results: A search was made in biomedical databases for randomized controlled trials published between 1987 and 2017 on angiotensin-converting enzyme inhibitors (ACEIs), beta-blockers (BBs), angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs), ivabradine (IVA), or angiotensin receptor-neprilysin inhibitors (ARNI). A total of 58 relevant trials were identified. The relative efficacy of each treatment group (or combination) in terms of all-cause mortality, cardiovascular mortality, all-cause hospitalizations and hospitalizations for heart failure, per patient-year of follow-up, were combined in a random-effects Bayesian NMA. The pairwise comparison between each regimen and for each outcome was estimated. The NMA was dominated by 15 large-scale trials with between 1984 and 18 898 patient-years of follow-up. Combinations of drug groups showed incremental benefits on outcomes over single groups. The most effective combinations were ARNI+BB + MRA and ACEI+BB + MRA + IVA, showing reductions in all-cause mortality (vs. placebo) of 62% and 59%, respectively; hazard ratios were 0.38 [credible interval (CrI) 0.20-0.65] and 0.41 (CrI 0.21-0.70); and in all-cause hospitalizations with reductions of 42% for both. These two combinations were also the most effective for the other outcomes studied.Conclusion: Our analysis shows that the incremental use of combinations of disease-modifying therapies has resulted in the progressive improvement in mortality and hospitalization outcomes in HFrEF. Our findings support the current guideline recommendations. [ABSTRACT FROM AUTHOR]

Objective: The ketones d-β-hydroxybutyrate (BHB) and acetoacetate are elevated during prolonged fasting or during a "ketogenic" diet. Although weight loss on a ketogenic diet may be associated with decreased appetite and altered gut hormone levels, it is unknown whether such changes are caused by elevated blood ketones. This study investigated the effects of an exogenous ketone ester (KE) on appetite.Methods: Following an overnight fast, subjects with normal weight (n = 15) consumed 1.9 kcal/kg of KE, or isocaloric dextrose (DEXT), in drinks matched for volume, taste, tonicity, and color. Blood samples were analyzed for BHB, glucose, insulin, ghrelin, glucagon-like peptide 1 (GLP-1), and peptide tyrosine tyrosine (PYY), and a three-measure visual analogue scale was used to measure hunger, fullness, and desire to eat.Results: KE consumption increased blood BHB levels from 0.2 to 3.3 mM after 60 minutes. DEXT consumption increased plasma glucose levels between 30 and 60 minutes. Postprandial plasma insulin, ghrelin, GLP-1, and PYY levels were significantly lower 2 to 4 hours after KE consumption, compared with DEXT consumption. Temporally related to the observed suppression of ghrelin, reported hunger and desire to eat were also significantly suppressed 1.5 hours after consumption of KE, compared with consumption of DEXT.Conclusions: Increased blood ketone levels may directly suppress appetite, as KE drinks lowered plasma ghrelin levels, perceived hunger, and desire to eat. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to test whether behavioral weight loss (BWL) intervention decreases headaches in women with comorbid migraine and overweight or obesity.Methods: This randomized, single-blind trial allocated women 18 to 50 years old with 4 to 20 migraine days per month and a BMI = 25.0-49.9 kg/m2 to 16 weeks of BWL (n = 54), which targeted exercise and eating behaviors for weight loss, or to migraine education control (ME, n = 56), which delivered didactic instruction on migraine and treatments. Participants completed a 4-week smartphone headache diary at baseline, posttreatment (16-20 wk), and follow-up (32-36 wk). The primary outcome was posttreatment change in migraine days per month, analyzed via linear mixed effects models.Results: Of 110 participants randomly assigned, 85 (78%) and 80 (73%) completed posttreatment and follow-up. Although the BWL group achieved greater weight loss (mean [95% CI] in kilograms) than the ME group at posttreatment (-3.8 [-2.5 to -5.0] vs. + 0.9 [-0.4 to 2.2], P < 0.001) and follow-up (-3.2 [-2.0 to -4.5] vs. + 1.1 [-0.2 to 2.4], P < 0.001), there were no significant group (BWL vs. ME) differences (mean [95% CI]) in migraine days per month at posttreatment (-3.0 [-2.0 to -4.0] vs. -4.0 [-2.9 to -5.0], P = 0.185) or follow-up (-3.8 [-2.7 to -4.8] vs. -4.4 [-3.4 to -5.5], P = 0.378).Conclusions: Contrary to hypotheses, BWL and ME yielded similar, sustained reductions in migraine headaches. Future research should evaluate whether adding BWL to standard pharmacological and/or nonpharmacological migraine treatment approaches yields greater benefits. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of a community-based lifestyle behavioral intervention on intakes of fat, fruits, vegetables, fast foods, and beverages in low-income young mothers with overweight or obesity.Methods: Participants were randomly assigned to an intervention (watching video lessons at home plus peer support group teleconferences) or a comparison group. General linear mixed model analyses were utilized to determine mean differences between the groups (212 intervention, 126 comparison) immediately following and 3 months (196 intervention, 115 comparison) after the intervention.Results: Immediately after the intervention, the intervention group had significantly lower mean scores in intakes of fat (effect size [d] = 0.24), fast foods (d = 0.33), and non-sugar-sweetened beverages (d = 0.27) than the comparison group. No significant group differences were observed for intakes of fruits, vegetables, or sugar-sweetened beverages. Three months after the intervention, no significant group differences were observed for intakes of fat, fruits, vegetables, fast foods, and both sugar- and non-sugar-sweetened beverages.Conclusions: The intervention group improved dietary intakes of fat and fast foods but not fruits, vegetables, or beverages over the short term. Our intervention had no long-term effect on dietary intake behaviors. [ABSTRACT FROM AUTHOR]

Objective: To test the feasibility of a comprehensive behavioral intervention (CBI) program that combines intense exercises with an education program, to be implemented at a later stage (3 months) following total knee replacement (TKR), and to get a first impression of the effects of the CBI as compared to a standard of care exercise (SCE) program on the outcomes of physical function and physical activity.Methods: A total of 44 subjects participated in a 3-month program of either CBI or SCE, followed by 3 months of a home exercise program. Outcomes of physical function and physical activity were measured at baseline and at 6-month followup. Analysis of variance was used to compare statistical differences between groups, whereas responder analyses were used for clinically important differences.Results: The CBI was found to be safe and well tolerated. As compared to the SCE group, the CBI group had less pain (P = 0.035) and better physical function based on the Short Form 36 health survey (P = 0.017) and the single-leg stance test (P = 0.037). The other outcome measures did not demonstrate statistically significant differences between the 2 groups. Results from the responder analysis demonstrated that the CBI group had a 36% higher rate of responders in physical function as compared to the SCE group. Also, the CBI group had 23% more responders in the combined domains of physical function and physical activity.Conclusion: The CBI program is feasible and improves physical function and physical activity in patients several months after TKR. Larger pragmatic randomized trials are needed to confirm the results of this study. [ABSTRACT FROM AUTHOR]

Objective: This study aims to assess whether an intensive lifestyle intervention (ILI) for weight reduction precipitates binge eating (BE) and whether BE attenuates 4-year weight loss among participants with type 2 diabetes and overweight or obesity.Methods: Participants (N = 4,901) were from Look AHEAD, a randomized controlled trial that compared ILI to diabetes support and education (DSE). Annual assessments of measured weight and self-reported BE were used. By using the yearly time points when a person endorsed BE, participants were classified as no BE, remitted BE, incident BE, inconsistent BE (2-3 years, including baseline), and consistent BE (≥ 4 years, including baseline). Cox regression and mixed-effects models were used for analyses.Results: ILI participants were marginally more likely to report incident BE at year 4 than those in DSE (P = 0.06). At year 4, ILI participants with remitted BE lost more weight (4.7 ± 0.8%) than those with consistent BE (1.9 ± 1.0%; P = 0.03). ILI participants with no BE lost more weight (4.6 ± 0.2%) than those with incident BE (3.1 ± 0.6%; P = 0.02) and consistent BE (P = 0.01). DSE participants with remitted BE lost more weight than those with incident and consistent BE.Conclusions: Preexisting BE did not seem to be a contraindication for ILI, although persistent BE attenuated weight loss. Patients who report new or ongoing BE may need additional treatment. [ABSTRACT FROM AUTHOR]

Feeding behaviors have an important impact on children's nutritional status and are essential to consider when implementing nutrition programs. The objective of this study was to explore and compare feeding behaviors related to supplementary feeding with corn-soy blends (CSB) and lipid-based nutrient supplements (LNS) based on best practice feeding behaviors. The study was conducted as part of a randomized controlled trial assessing the effectiveness of new formulations of CSB and LNS and comprised 1,546 children from 6 to 23 months. The study included a mixed methods approach using questionnaires, focus group discussions and home visits and interviews with a subsample of 20 caretakers of trial participants. We found that LNS, compared to CSB, were more likely to be mixed into other foods (OR [95% CI] 1.7 [1.3-2.2], p = <.001), served with a meal (OR [95% CI] 1.6 [1.1-2.3], p = <.018)or between meals (OR [95% CI] 1.5 [1.1-1.9], p = <.005), and fed using an encouraging feeding style (mean difference in percentage points [95% CI] 23% [6%:40%], p = .01). CSB were more likely to be fed using a forced feeding style (mean difference in percentage points [95% CI] 18% [3%:33%], p = .02) and were often observed to be served unprepared. The main differences in feeding behaviors between the two diet groups were linked to how and when supplements were served. Educational instructions should therefore be adapted according to the supplement provided; when providing CSB, efforts should be made to promote an encouraging feeding style, and emphasis should be made to ensure preparations are made according to recommendations. [ABSTRACT FROM AUTHOR]

Objective: To examine the safety and efficacy of a high-intensity (HI) progressive rehabilitation protocol beginning 4 days after total knee arthroplasty (TKA) compared to a low-intensity (LI) rehabilitation protocol.Methods: A total of 162 participants (mean ± SD ages 63 ± 7 years; 89 women) were randomized to either the HI group or LI group after TKA. Key components of the HI intervention were the use of progressive resistance exercises and a rapid progression to weight-bearing exercises and activities. Both groups were treated in an outpatient setting 2 to 3 times per week for 11 weeks (26 total sessions). Outcomes included the stair climbing test (SCT; primary outcome), timed-up-and-go (TUG) test, 6-minute walk (6MW) test, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 12-item Short Form health survey (SF-12), knee range of motion (ROM), quadriceps and hamstring strength, and quadriceps activation. Outcomes were assessed preoperatively and at 1, 2, 3 (primary end point), 6, and 12 months postoperatively.Results: There were no significant differences between groups at 3 or 12 months in SCT, TUG, 6MW, WOMAC scores, knee ROM, quadriceps and hamstrings strength, quadriceps activation, or adverse event rates. By 12 months, outcomes on the 6MW, TUG, WOMAC, SF-12, quadriceps and hamstring strength, and quadriceps activation had improved beyond baseline performance in both groups.Conclusion: Both the HI and LI interventions were effective in improving strength and function after TKA. HI progressive rehabilitation is safe for individuals after TKA. However, its effectiveness may be limited by arthrogenic muscular inhibition in the early postoperative period. [ABSTRACT FROM AUTHOR]

Background and Purpose: Our initial aim was to generate cannabinoid agents that control spasticity, occurring as a consequence of multiple sclerosis (MS), whilst avoiding the sedative side effects associated with cannabis. VSN16R was synthesized as an anandamide (endocannabinoid) analogue in an anti-metabolite approach to identify drugs that target spasticity.Experimental Approach: Following the initial chemistry, a variety of biochemical, pharmacological and electrophysiological approaches, using isolated cells, tissue-based assays and in vivo animal models, were used to demonstrate the activity, efficacy, pharmacokinetics and mechanism of action of VSN16R. Toxicological and safety studies were performed in animals and humans.Key Results: VSN16R had nanomolar activity in tissue-based, functional assays and dose-dependently inhibited spasticity in a mouse experimental encephalomyelitis model of MS. This effect occurred with over 1000-fold therapeutic window, without affecting normal muscle tone. Efficacy was achieved at plasma levels that are feasible and safe in humans. VSN16R did not bind to known CB1 /CB2 /GPPR55 cannabinoid-related receptors in receptor-based assays but acted on a vascular cannabinoid target. This was identified as the major neuronal form of the big conductance, calcium-activated potassium (BKCa ) channel. Drug-induced opening of neuronal BKCa channels induced membrane hyperpolarization, limiting excessive neural-excitability and controlling spasticity.Conclusions and Implications: We identified the neuronal form of the BKCa channel as the target for VSN16R and demonstrated that its activation alleviates neuronal excitability and spasticity in an experimental model of MS, revealing a novel mechanism to control spasticity. VSN16R is a potential, safe and selective ligand for controlling neural hyper-excitability in spasticity. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the impact of the Nursing Home Value-Based Purchasing demonstration on quality of care and Medicare spending.Data Sources/study Setting: Administrative and qualitative data from Arizona, New York, and Wisconsin nursing homes over the base-year (2008-2009) and 3-year (2009-2012) demonstration period.Study Design: Nursing homes were randomized to the intervention in New York, while the comparison facilities were constructed via propensity score matching in Arizona and Wisconsin. We used a difference-in-difference analysis to compare outcomes across the base-year relative to outcomes in each of the three demonstration years. To provide context and assist with interpretation of results, we also interviewed staff members at participating facilities.Principal Findings: Medicare savings were observed in Arizona in the first year only and Wisconsin for the first 2 years; no savings were observed in New York. The demonstration did not systematically impact any of the quality measures. Discussions with nursing home administrators suggested that facilities made few, if any, changes in response to the demonstration, leading us to conclude that the observed savings likely reflected regression to the mean rather than true savings.Conclusion: The Federal nursing home pay-for-performance demonstration had little impact on quality or Medicare spending. [ABSTRACT FROM AUTHOR]

Objective: Food cravings are thought to be the result of conditioning or pairing hunger with consumption of certain foods.Methods: In a 2-year weight loss trial, subjects were randomized to one of four diets that varied in macronutrient content. The Food Craving Inventory (FCI) was used to measure cravings at baseline and at 6 and 24 months. Food intake was also measured at those time points. To measure free-living consumption of food items measured in the FCI, items on the FCI were matched to the foods consumed from the food intake assessments. Secondarily, the amount of food consumed on food intake assessments from foods on the FCI was analyzed.Results: Three hundred and sixty-seven subjects with overweight and obesity were included. There was an association between change from baseline FCI item consumption and change in cravings at months 6 (P < 0.001) and 24 (P < 0.05). There was no association between change from baseline amount of energy consumed per FCI item and change in cravings.Conclusions: Altering frequency of consuming craved foods is positively associated with cravings; however, changing the amount of foods consumed does not appear to alter cravings. These results support the conditioning model of food cravings and provide guidance on how to reduce food cravings. [ABSTRACT FROM AUTHOR]

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Objective: The effective components of interventions for reducing excessive gestational weight gain (GWG) remain to be identified. This study investigated the sociodemographic, physical, psychosocial, and environmental correlates of online GWG tracking and its independent association with GWG outcomes.Methods: Eight hundred ninety-eight women in the intervention arms of a randomized trial assessing the effectiveness of an integrated online and mobile phone behavioral intervention to decrease the prevalence of excessive GWG were included in this secondary analysis. Data were analyzed using χ2 analysis and modified Poisson and linear regression approaches.Results: Only 16.5% of low-income (Medicaid-eligible) women consistently tracked GWG, as did 34.2% of not-low-income women. More highly educated, older, and white women were more likely to be consistent GWG trackers. Among not-low-income women, consistent GWG tracking was associated with 2.35 kg less GWG (95% CI: -3.23 to -1.46 kg; P < 0.0001) and a reduced risk of excessive GWG (RR 0.73; 95% CI: 0.59 to 0.89; P = 0.002).Conclusions: Electronic tracking of GWG is an effective component of electronic and mobile health interventions aiming to decrease the prevalence of excessive GWG in not-low-income women. Income group-specific motivators are needed to increase the prevalence of GWG tracking. [ABSTRACT FROM AUTHOR]

Objectives: To explore whether, in early fetal growth restriction (FGR), the longitudinal pattern of fetal heart rate (FHR) short-term variation (STV) can be used to identify imminent fetal distress and whether abnormalities of FHR recordings are associated with 2-year infant outcome.Methods: The original TRUFFLE study assessed whether, in early FGR, delivery based on ductus venosus (DV) Doppler pulsatility index (PI), in combination with safety-net criteria of very low STV on cardiotocography (CTG) and/or recurrent FHR decelerations, could improve 2-year infant survival without neurological impairment in comparison with delivery based on CTG monitoring only. This was a secondary analysis of women who delivered before 32 weeks and had consecutive STV data recorded > 3 days before delivery and known infant outcome at 2 years of age. Women who received corticosteroids within 3 days of delivery were excluded. Individual regression line algorithms of all STV values, except the last one before delivery, were calculated. Life tables and Cox regression analysis were used to calculate the daily risk for low STV or very low STV and/or FHR decelerations (below DV group safety-net criteria) and to assess which parameters were associated with this risk. Furthermore, it was assessed whether STV pattern, last STV value or recurrent FHR decelerations were associated with 2-year infant outcome.Results: One hundred and forty-nine women from the original TRUFFLE study met the inclusion criteria. Using the individual STV regression lines, prediction of a last STV below the cut-off used by the CTG monitoring group had sensitivity of 42% and specificity of 91%. For each day after study inclusion, the median risk for low STV (CTG group cut-off) was 4% (interquartile range (IQR), 2-7%) and for very low STV and/or recurrent FHR decelerations (below DV group safety-net criteria) was 5% (IQR, 4-7%). Measures of STV pattern, fetal Doppler (arterial or venous), birth-weight multiples of the median and gestational age did not usefully improve daily risk prediction. There was no association of STV regression coefficients, a low last STV and/or recurrent FHR decelerations with short- or long-term infant outcomes.Conclusion: The TRUFFLE study showed that a strategy of DV monitoring with safety-net criteria of very low STV and/or recurrent FHR decelerations for delivery indication could increase 2-year infant survival without neurological impairment. This post-hoc analysis demonstrates that, in early FGR, the daily risk of abnormal CTG, as defined by the DV group safety-net criteria, is 5%, and that prediction is not possible. This supports the rationale for CTG monitoring more often than daily in these high-risk fetuses. Low STV and/or recurrent FHR decelerations were not associated with adverse infant outcome and it appears safe to delay intervention until such abnormalities occur, as long as DV-PI is within normal range. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: In-person lifestyle interventions for obesity treatment yield significant improvements in depression. These improvements may be attributed to the excellent weight losses produced by in-person interventions. In contrast, Internet programs yield more modest weight losses, and their effect on depression is unknown. This study is the first to examine whether Internet-delivered obesity treatment impacts depressive symptoms.Methods: Participants (N = 136) were randomized to either a community campaign plus Internet behavioral weight loss (IBWL) or community campaign alone (Control). IBWL did not include online social support components. A measure of depressive symptoms was administered, and weight was objectively assessed.Results: Of the total sample, 24% met the clinical cutoff for elevated depression risk at baseline. IBWL participants lost more weight during treatment (P = 0.005) and experienced significantly greater improvements in depressive symptoms (P = 0.02). Among participants who met the clinical cutoff for elevated risk for depression at baseline, those assigned to IBWL had greater improvements in depressive symptoms during treatment compared to Control (P = 0.033). Consequently, at post-treatment, a smaller percentage of IBWL participants were at elevated risk for depression.Conclusions: This study is the first to show that Internet-delivered obesity treatment improves depression risk and depressive symptoms in individuals with overweight or obesity. [ABSTRACT FROM AUTHOR]

Objective: To determine the effect of prebiotic supplementation on metabolic endotoxemia and systemic inflammation in adults with overweight and obesity.Methods: Samples from a previously conducted randomized, double-blind, placebo-controlled trial were used for analysis. Participants were randomized to 21 g of oligofructose (n = 20; BMI 30.4 kg/m2 ) or a maltodextrin placebo (n = 17; BMI 29.5 kg/m2 ) for 12 weeks. A total of 37 participants had samples available for the current analysis. Resistin, adiponectin, plasminogen activator inhibitor-1 (PAI-1), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and macrophage chemoattractant protein-1 (MCP-1) were quantified using MILLIPLEX® assays. Lipopolysaccharide (LPS) was measured using PyroGene™ Recombinant Factor C Assay.Results: Plasma LPS concentrations were reduced by 40% in the oligofructose group over 12 weeks compared to a 48% increase in the placebo group (P = 0.04). PAI-1, a risk factor for thrombosis, was reduced to a greater extent in the oligofructose group (-17.3 ± 2.6 ng/ml) compared to the placebo group (-9.7 ± 1.8 ng/ml; P = 0.03). Oligofructose did not affect IL-6, TNF-α, MCP-1, adiponectin, or resistin.Conclusions: Oligofructose reduces metabolic endotoxemia and PAI-1. Incorporating prebiotics into the diet through supplements or functional foods may help mitigate some markers of obesity-associated inflammation. [ABSTRACT FROM AUTHOR]

As part of a breastfeeding promotion intervention trial in Nigeria, we provided one cell phone per group of 5–7 microcredit clients and instructed the group's cell phone recipient to share weekly breastfeeding voice and text messages with group members. We measured the feasibility and acceptability of using group cell phones by conducting semi‐structured exit interviews with 195 microcredit clients whose babies were born during the intervention (target group), in‐depth interviews with eight phone recipients and nine non‐phone recipients, and 16 focus group discussions with other microcredit clients. Women in the target group said the group phone worked well or very well (64%). They were motivated to try the recommended practices because they trusted the information (58%) and had support from others (35%). Approximately 44% of target women reported that their groups met and shared messages at least once a week. Women in groups that met at least weekly had higher odds of exclusive breastfeeding up to 6 months (OR 5.6, 95% CI 1.6, 19.7) than women in groups that never met. In‐depth interviews and focus group discussions indicated that non‐phone recipients had positive feelings towards phone recipients, the group phone met participants' needs, and messages were often shared outside the group. In conclusion, group cell phone messaging to promote breastfeeding among microcredit clients is feasible and acceptable and can be part of an effective behaviour change package. [ABSTRACT FROM AUTHOR]

Aim: To determine whether home-based, parent-delivered therapy comprising action observation (AO) and repeated practice (RP) improves upper limb function more than RP alone in children with unilateral cerebral palsy (UCP).Method: Design: single-blinded parallel-group randomized controlled trial with 1:1 allocation comparing AO+RP (intervention) with RP alone (control).Randomization: computer-generated, with allocation concealment by opaque sequentially-numbered envelopes.Setting: northern England, August 2011 to September 2013.Participants: 70 children with UCP; mean age 5.6 years (SD 2.1), 31 female.Intervention: home-based activities were provided, tailored to interests and abilities.Duration: 15 minutes/day, 5 days/week for 3 months.Assessments: Assisting Hand Assessment (AHA; primary outcome measure), Melbourne Assessment 2 (MA2), and ABILHAND-Kids at baseline, 3 months, and 6 months.Results: Outcome data was available at 3 months for 28 children in the AO+RP group and 31 controls, and at 6 months for 26 and 28 children respectively. There were no between-group differences in AHA, MA2, or ABILHAND-Kids at 3 or 6 months versus baseline (all p>0.05). Combined-group improvements (p<0.001), observed in AHA and MA2 at 3 months, were maintained at 6 months. ABILHAND-Kids also showed improvement at 3 months (p=0.003), maintained at 6 months.Interpretation: Parent-delivered RP (with or without AO) improves upper limb function and could supplement therapist input. [ABSTRACT FROM AUTHOR]

Objective: To explore factors that may influence use of comparative public reports for hospital maternity care.Data Sources: Four focus groups conducted in 2013 with 41 women and preintervention survey data collected in 2014 to 2015 from 245 pregnant women in North Carolina.Study Design: As part of a larger randomized controlled trial, we conducted qualitative formative research to develop an intervention that will be evaluated through pre- and postintervention surveys.Data Extraction Methods: Analysis of focus group transcripts examined participants' perceptions of high-quality maternity care and the importance of different quality measures. Quantitative analysis included descriptive results of the preintervention survey and subgroup analyses to examine the impact of race, education, and being a first-time mom on outcomes.Principal Findings: When describing high-quality maternity care, participants focused on interactions with providers, including respect for preferences and communication. The importance of quality measures was influenced by the extent to which they focused on babies' health, were perceived as the hospital's responsibility, and were perceived as representing "standard care." At baseline, 28 percent of survey respondents had used quality information to choose a hospital. Survey respondents were more aware of some quality measures (e.g., breastfeeding support) than others (e.g., episiotomy rates).Conclusions: Public reporting efforts could help increase relevance of maternity care quality measures by creating measures that reflect women's concerns, clearly explaining the hospital's role in supporting quality care, and showing how available quality measures can inform decisions about childbirth. [ABSTRACT FROM AUTHOR]

Objective: To determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components.Methods: In this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change.Results: Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, -1.9 kg (95% CI: -4.5, 0.8; P = 0.17), and 18 months, -1.7 kg (95% CI: -4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, -3.1 mg/dl (95% CI: -6.3, 0.1; P = 0.06), and 18 months, -4.1 mg/dl (95% CI: -7.3, -0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, -0.57 (95% CI: -0.95, -0.18; P = 0.004), and 18 months, -0.36 (95% CI: -0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C-reactive protein.Conclusions: Mindfulness enhancements to a diet-exercise program did not show substantial weight loss benefit but may promote long-term improvement in some aspects of metabolic health in obesity that requires further study. [ABSTRACT FROM AUTHOR]

Aim: To determine whether, in an impoverished South African community, an intervention that benefitted infant attachment also benefitted cognitive development.Method: Pregnant females were randomized to intervention (n=220) and no-treatment control groups (n=229). The intervention was home-based parenting support for attachment, delivered until 6 months postpartum. At 18 months, infants were assessed on attachment and cognitive development (Bayley Scales Mental Development Index [MDI]) (n=127 intervention, n=136 control participants). Infant MDI was examined in relation to intervention, socio-economic risk, antenatal depression, and infant sex and attachment.Results: Overall, there was little effect of the intervention on MDI (p=0.094, d=0.20), but there was an interaction between intervention and risk (p=0.03, ηp2=0.02). MDI scores of infants of lower risk intervention group mothers were, on average, 4.84 points higher than those of other infants (p=0.002, d=0.41). Antenatal depression was not significant once intervention and risk were controlled (p=0.08); there was no association between infant MDI and either sex (p=0.41) or attachment (p=0.56).Interpretation: Parenting interventions for infant cognitive development may benefit from inclusion of specific components to support infant cognition beyond those that support attachment, and may be most effective for infants over 6 months. They may need augmentation with other input where adversity is extreme. [ABSTRACT FROM AUTHOR]

Objective: Anti-tumor necrosis factor (anti-TNF) agents are frequently used in combination with methotrexate (MTX) to treat rheumatoid arthritis (RA). We investigated the effect of a background MTX dose, in combination with anti-TNF certolizumab pegol (CZP), on treatment efficacy and safety in RA patients.Methods: A pre-specified subgroup analysis comparing 2 MTX dosage categories (<15 mg/week and ≥15 mg/week) was carried out using data pooled from phase III clinical trials, Rheumatoid Arthritis Prevention of Structural Damage 1 (RAPID 1) and RAPID 2, according to treatment group: CZP 200 mg, CZP 400 mg, or placebo, every 2 weeks. Inclusion criteria required MTX dosage ≥10 mg/week. Efficacy end points included week 24 American College of Rheumatology criteria for 20%, 50%, and 70% improvement (ACR20/50/70) responses analyzed by logistic regression, and changes from baseline in the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) and the modified Sharp/van der Heijde score (SHS) were analyzed by analysis of covariance. Incidence rates of treatment-emergent adverse events (TEAEs) were categorized by baseline MTX dose. Post hoc sensitivity analysis investigated 3 MTX dose categories: ≤10 mg/week, >10 and ≤15 mg/week, and >15 mg/week.Results: A total of 638, 635, and 325 patients received CZP 200 mg, CZP 400 mg, and placebo, respectively. At week 24, treatment responses in both CZP groups were uninfluenced by baseline MTX dose category, and were superior to the placebo group for all investigated end points: ACR20/50/70, DAS28-ESR, and SHS. TEAE incidence rates were higher in patients receiving MTX ≥15 mg/week for most TEAE types across treatment groups.Conclusion: CZP efficacy was not affected by background MTX dose category. It can be hypothesized that to minimize TEAEs, background MTX doses could be tailored to individual patient tolerance without affecting CZP efficacy. [ABSTRACT FROM AUTHOR]