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Behaviour change communication (BCC) can improve infant and young child nutrition (IYCN) knowledge, practices, and health outcomes. However, few studies have examined whether the improved knowledge persists after BCC activities end. This paper assesses the effect of nutrition sensitive social protection interventions on IYCN knowledge in rural Bangladesh, both during and after intervention activities. We use data from two, 2-year, cluster randomised control trials that included nutrition BCC in some treatment arms. These data were collected at intervention baseline, midline, and endline, and 6-10 months after the intervention ended. We analyse data on IYCN knowledge from the same 2,341 women over these 4 survey rounds. We construct a number correct score on 18 IYCN knowledge questions and assess whether the impact of the BCC changes over time for the different treatment groups. Effects are estimated using ordinary least squares accounting for the clustered design of the study. There are 3 main findings: First, the BCC improves IYCN knowledge substantially in the 1st year of the intervention; participants correctly answer 3.0-3.2 more questions (36% more) compared to the non-BCC groups. Second, the increase in knowledge between the 1st and 2nd year was smaller, an additional 0.7-0.9 correct answers. Third, knowledge persists; there are no significant decreases in IYCN knowledge 6-10 months after nutrition BCC activities ended. [ABSTRACT FROM AUTHOR]

Millions of children in low-income and middle-income countries falter in linear growth and neurobehavioral development early in life. This faltering may be caused by risk factors that are associated with both growth and development, such as insufficient dietary intake and infection in infancy. Alternatively, these risk factors may be indicative of an environment that constrains both linear growth and development through different mechanisms. In a cluster-randomized trial in Burkina Faso, we previously found that provision of lipid-based nutrient supplements plus malaria and diarrhoea treatment from age 9 to 18 months resulted in positive effects of ~0.3 standard deviation on length-for-age z-score (LAZ) and of ~0.3 standard deviation on motor, language and personal-social development scores at age 18 months. In this paper, we examined whether the effect of the intervention on developmental scores was mediated by the effect on LAZ, or, alternatively, whether the intervention had independent effects on growth and development. For motor, language, and personal-social z-scores, the effect of the intervention decreased from 0.32 to 0.21, from 0.33 to 0.27 and from 0.35 to 0.29, respectively, when controlling for change in LAZ from 9 to 18 months. All effects remained significant. These results indicate that the intervention had independent positive effects on linear growth and development, suggesting that these effects occurred through different mechanisms. © 2016 John Wiley & Sons Ltd [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the efficacy of acupuncture in the treatment of pressure ulcers. Randomized controlled trials evaluating the effects of acupuncture on pressure ulcers were identified through a comprehensive literature search on public database. The quality assessment of the included trials was performed based on the guidance of the Cochrane Reviewers' Handbook, and pooled analyses were performed by using the RevMan 5.4 software. The pooled results demonstrated that acupuncture in combination with standard wound care was significantly superior to standard wound care alone with regard to effective rate (RR 1.17, 95% CI [1.10, 1.24]), reduction in Wound Size (MD −2.78, 95% CI [−2.43, −1.44]), healing time (MD −6.24, 95% CI [−12.32, −0.17]) and the amount of 24‐h exudate (MD −0.86, 95% CI [−1.54, −0.18]). In conclusion, this study suggests that acupuncture can be used as an adjunctive therapy to promote healing of pressure ulcers. [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]

Prenatal iron supplementation improves children's health and cognitive performance, but few studies explore behavioural development. This study assessed the effects of adjusting prenatal iron supplementation to maternal iron stores during early pregnancy on children's behavioural problems. Randomized controlled trial conducted in Tarragona (Spain) involving 230 nonanaemic pregnant women and their children after a 4‐year follow‐up. Based on haemoglobin (Hb) levels before gestational week (GW) 12, women receive different iron doses: those with Hb = 110–130 g/L were randomized to receive 80 or 40 mg/day and those with Hb > 130 g/L were randomized to receive 20 or 40 mg/day. Maternal iron stores at GW12 were classified using serum ferritin (SF) as low (SF < 15 µg/L), normal (SF = 15–65 µg/L), and normal‐high (SF > 65 µg/L). Children's behaviour was assessed by parents using the Child Behaviour Checklist for ages 1.5–5 years and the Behaviour Rating Inventory of Executive Function‐Preschool Version, and by teachers using the Teacher's Report Form for ages 1.5–5 years. Multivariable regression models were performed. Taking 80 mg/day of iron improved child behaviour when women had low iron stores but worsened it when mothers had normal–high iron stores, except for depressive and attention/hyperactivity problems. Taking 20 mg/day of iron improved behaviour only in those children whose mothers had SF > 65 µg/L in early pregnancy. Additionally, executive functioning improved at high doses of prenatal iron when maternal baseline SF < 15 µg/L. Adjusting prenatal iron supplementation to both maternal baseline Hb levels and iron stores reduces behavioural problems in 4‐year‐old children. Key messages: Prenatal iron supplementation succeeds in improving maternal haematological outcomes and cognitive performance of children, but few studies have focused on behavioural development.Prenatal iron supplementation adjusted to maternal iron stores reduces behavioural problems in 4‐year‐old children.Maternal iron stores early in pregnancy should be measured in addition to haemoglobin concentration.These findings contribute greatly to the advancement of public health by giving physicians the tools to prescribe the most appropriate dose of iron supplementation to contribute to better child development. [ABSTRACT FROM AUTHOR]

To evaluate the status of a 7‐month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent‐to‐Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t‐test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound‐closing effects at month 6 (P =.0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P =.0391,.0391, and.0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P =.03 for all points). A potentially clinically meaningful 0.15 increase in Ankle‐Brachial Index was observed in the VM202 group at day 210 in the ITT population (P =.0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites. [ABSTRACT FROM AUTHOR]

Prolonged wound discharge is a common postoperative complication of orthopaedic procedures and a risk factor for implant‐related infection. Occlusive wound closure methods have previously been suggested to reduce or even prevent this complication. We performed a randomised controlled trial on 70 patients who underwent surgical treatment for metastatic bone disease involving the proximal femur at our centre between January 2017 and August 2018. At conclusion of the tumour resection and endoprosthetic reconstruction procedure, patients were randomised to either occlusive wound closure (n = 35), using the Dermabond Prineo‐22 skin closure system, or routine wound closure with conventional skin staples (n = 35). Skin closure with occlusive wound closure resulted in a lesser degree (P <.0001) and shorter duration of postoperative wound discharge (HR 2.89 [95% CI 1.6–5.05], P <.0018). Compared with staples, surgical wounds were already dry after a mean of 3.5 days [95% CI 3.2–3.9] versus 6.1 days [95% CI 4.8–7.3] (P <.0001). Prolonged wound discharge for 7 days or more was observed in 23% of patients (n = 8) in the Staples‐group but was entirely absent in the occlusive wound closure group (P <.003). This study provides strong evidence that occlusive wound closure reduces frequency, degree, and duration of wound discharge in a patient population at particularly high risk for this complication. [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]

Inappropriate complementary feeding contributes to linear growth faltering in early childhood. Behaviour change interventions have been effective at improving practice, but few studies have investigated the effects of multicomponent integrated interventions. We conducted a cluster‐randomized controlled trial in rural Bangladesh in which geographic clusters were randomized into seven arms: water treatment (W), sanitation (S), handwashing (H), water, sanitation, and handwashing (WSH), improved nutrition with infant and young child feeding messages and lipid‐based nutrient supplementation for 6‐ to 24‐month olds (N), N+WSH, and control. The objective of this paper was to examine the independent and combined effects of interventions on indicators of complementary feeding. Approximately 1 and 2 years after initiation of the intervention, research assistants surveyed mothers about infant feeding practices. Complementary feeding was examined using the World Health Organization indicators of infant and young child feeding practices. We used Poisson regression models to estimate prevalence ratios and linear regression models for prevalence differences with clustered sandwich estimators to adjust for clustering. A total of 4,718 households from 720 clusters were surveyed at year 1 and 4,667 at year 2. The children in the nutrition arms had a higher prevalence of meeting the minimum dietary diversity score compared with controls (year 1: N: 66.4%; N+WSH: 65.0% vs. C:32.4%; year 2: N: 91.5%; N+WSH: 91.6% vs. C:77.7%). Children in the nutrition arms received diverse food earlier than the children in control arm. In addition, the average consumption of lipid‐based nutrient supplementation was >90% in each follow‐up. Nutrition‐specific interventions could be integrated with nutrition‐sensitive interventions such as WSH without compromising the uptake of the nutrition intervention. [ABSTRACT FROM AUTHOR]

Exclusive breastfeeding (EBF) for the first 6 months has established benefits, yet had slow improvements globally. Little is known about electronic job aid‐assisted counselling to support EBF. As a secondary outcome of a cluster randomized controlled trial in Bangladesh, we assessed the effect of electronic job aid‐supported nutrition counselling and practical demonstration on EBF. We randomized pregnant women to one of five study arms in the trial and followed mother–child dyads until 2 years of age. Community health workers (CHWs) provided breastfeeding counselling with or without prenatal and complementary nutrient supplements in all four intervention arms. The comparison arm continued with the usual practice where mothers could receive nutrition counselling at routine antenatal and postnatal care, and during careseeking for childhood illnesses. We assessed breastfeeding indicators at birth and monthly until the child was 6 months old, in both intervention and comparison arms. To evaluate the effect of nutrition counselling on breastfeeding, we combined all four intervention arms and compared them with the comparison arm. Intervention newborns had half the risk (relative risk [RR]: 0.54, 95% confidence interval [CI]: 0.39, 0.76) of receiving prelacteal feeds than those in the comparison arm. EBF declined steeply in the comparison arm after 3 months of age. EBF was 16% higher in the intervention than the comparison arm at 4 months (RR: 1.16, 95% CI: 1.08, 1.23) and 22% higher at 5 months of age (RR: 1.22, 95% CI: 1.12, 1.33). Maternal background and household characteristics did not modify the intervention effect, and we observed no difference in EBF among caesarean versus vaginal births. Breastfeeding counselling and practical demonstration using an electronic job aid by CHWs are promising interventions to improve EBF and are scalable into existing community‐based programmes. Key messages: Using an electronic job aid, repeated, one‐to‐one counselling and practical demonstration to mothers by locally recruited CHWs reduced prelacteal feeding and improved EBF practice by delaying the early introduction of complementary food.The positive effect of counselling on EBF remains similar with or without nutrient supplementation.Electronic job aid supported counselling to promote breastfeeding should be integrated into existing community‐based maternal and child health programmes. [ABSTRACT FROM AUTHOR]

Micronutrient supplementation is widely used to prevent stunting in children under 5 years in low‐ and middle‐income countries (LMIC), but the impact of treatment has been disappointing, possibly due to non‐compliance. Our aim was to deliver long‐term micronutrient supplementation via a novel, culturally acceptable liquid food to improve linear growth in a high stunting prevalence region. In a randomised control trial, 971 children aged 6–72 months received either 'Chispuditos®' (n = 681), a hot drink (atole) fortified with micronutrients (atole + MN) (9 mg/zinc, 12.5 mg/iron), or lactose‐free milk (n = 290) for 18 months. Primary outcomes were changes in length/height‐for‐age (HAZ) score and the prevalence of stunting at 18‐month follow‐up. Adherence was monitored monthly, and 73% children in atole + MN group consumed at least half their daily zinc and iron requirement. At 18 months, there was no difference between the treatments in growth [mean change in HAZ −0.02 (95% CI −0.12, 0.08)] or stunting [atole + MN 41%, milk 41%; RR 0.99 (95% CI 0.84, 1.19)]. There were no differences in haemoglobin (HB), ferritin or zinc. No children had iron deficiency anaemia (IDA) at outcome, but zinc deficiency remained equally prevalent in both groups: atole + MN 35%, milk 35% [RR 1.02 (95% CI 0.83, 1.24)]. There was no difference in morbidity between the groups, and micronutrient status was unrelated to HAZ. Long‐term micronutrient supplementation via a culturally acceptable food had no impact on stunting or morbidity, raising the question of whether large‐scale micronutrient supplementation is worthwhile. [ABSTRACT FROM AUTHOR]

Adequate maternal healthcare practices are crucial to both maternal and infant nutrition outcomes. The Sylhet region of Bangladesh is vulnerable and performs poorly, as maternal and child health indicators are falling behind compared to other areas. Suchana, a large‐scale intervention programme aims to improve the health and nutritional status of mothers and children in this region. The objective of the present analysis is to assess the changes in indicators related to maternal healthcare practices among Suchana beneficiaries. We obtained data from the Suchana baseline and endline evaluation survey. Descriptive statistics were employed to summarize data. The following maternal healthcare practices were considered: if a Suchana beneficiary mother received antenatal care (ANC) from skilled service providers, took day time resting during pregnancy, consumed additional diet during pregnancy, took at least 100 iron‐folic acid (IFA) tablets during pregnancy and took a vitamin A capsule after delivery. Logistic regression analysis was performed to assess the impact of the Suchana intervention on maternal healthcare practices. The prevalence of the outcome variables at endline in the intervention area were as follows: 40% of mothers received at least four ANC from skilled service providers, 50% practiced daytime resting during pregnancy, 51% consumed additional diet during pregnancy, 41% took at least 100 iron‐folic acid tablets during pregnancy, 39% received postnatal care and 30% took a vitamin A capsule after delivery. The Suchana intervention significantly, positively improved indicators related to maternal healthcare practices; these findings support future larger‐scale programmes to improve maternal healthcare practices among vulnerable people in rural Bangladesh. [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]

Maternal iodine (I) status is critical in embryonic and foetal development. We examined the effect of preconception iodine supplementation on maternal iodine status and on birth outcomes. Non‐pregnant women in Guatemala, India and Pakistan (n ~ 100 per arm per site) were randomized ≥ 3 months prior to conception to one of three intervention arms: a multimicronutrient‐fortified lipid‐based nutrient supplement containing 250‐μg I per day started immediately after randomization (Arm 1), the same supplement started at ~12 weeks gestation (Arm 2) and no intervention supplement (Arm 3). Urinary I (μg/L) to creatinine (mg/dl) ratios (I/Cr) were determined at 12 weeks for Arm 1 versus Arm 2 (before supplement started) and 34 weeks for all arms. Generalized linear models were used to assess the relationship of I/Cr with arm and with newborn anthropometry. At 12 weeks gestation, adjusted mean I/Cr (μg/g) for all sites combined was significantly higher for Arm 1 versus Arm 2: (203 [95% CI: 189, 217] vs. 163 [95% CI: 152, 175], p < 0.0001). Overall adjusted prevalence of I/Cr < 150 μg/g was also lower in Arm 1 versus Arm 2: 32% (95% CI: 26%, 38%) versus 43% (95% CI: 37%, 49%) (p = 0.0052). At 34 weeks, adjusted mean I/Cr for Arm 1 (235, 95% CI: 220, 252) and Arm 2 (254, 95% CI: 238, 272) did not differ significantly but were significantly higher than Arm 3 (200, 95% CI: 184, 218) (p < 0.0001). Nominally significant positive associations were observed between I/Cr at 12 weeks and birth length and head circumference z‐scores (p = 0.028 and p = 0.005, respectively). These findings support the importance of first trimester iodine status and suggest need for preconception supplementation beyond salt iodization alone. [ABSTRACT FROM AUTHOR]

Eggs are a rich source of multiple nutrients that support child growth and development. Provision of eggs as a complementary food may improve dietary adequacy among young children at risk for undernutrition. Our objective was to test the impact of an egg intervention on the adequacy of total nutrient intakes and micronutrient density among 6‐ to 15‐month‐old Malawian children. Children 6 to 9 months old, living in Mangochi District, Malawi, were randomly assigned to the intervention group (n = 331) receiving an egg per day or a control group (n = 329) consuming their usual diet. Dietary intakes of macronutrients, vitamins and minerals were assessed using 24‐h recalls at baseline, 3‐month midline and 6‐month endline, with repeat recalls in a subsample. Usual nutrient intake and micronutrient density distributions were modelled to estimate group means and prevalence of inadequacy. Group differences at midline and endline were tested using unequal variance t tests with bootstrapped standard errors. The egg intervention resulted in higher intakes of fat and protein and lower intakes of carbohydrates. The egg group had lower prevalence of inadequacy for selenium, vitamin A, riboflavin, vitamin B5, vitamin B12 and choline. Micronutrient density inadequacy was lower in the egg group for vitamin A and choline at midline and endline, riboflavin at midline and vitamin B5 at endline. Inadequacy of nutrient intakes or density remained highly prevalent in both groups for multiple micronutrients. Though the egg intervention increased intakes of protein and several micronutrients, total intakes and micronutrient density of multiple micronutrients remained far below recommendations. [ABSTRACT FROM AUTHOR]

Ready‐to‐use therapeutic foods (RUTF) used to treat children with severe acute malnutrition (SAM) are costly, and the prescribed dosage has not been optimized. The MANGO trial, implemented by Action Contre la Faim in Burkina Faso, proved the non‐inferiority of a reduced RUTF dosage in community‐based treatment of uncomplicated SAM. We performed a cost‐minimization analysis to assess the economic impact of transitioning from the standard to the reduced RUTF dose. We used a decision‐analytic model to simulate a cohort of 399 children/arm, aged 6–59 months and receiving SAM treatment. We adopted a societal perspective: direct medical costs (drugs, materials and staff time), non‐medical costs (caregiver expenses) and indirect costs (productivity loss) in 2017 international US dollar were included. Data were collected through interviews with 35 caregivers and 20 informants selected through deliberate sampling and the review trial financial documents. The overall treatment cost for 399 children/arm was $36,550 with the standard and $30,411 with the reduced dose, leading to $6,140 (16.8%) in cost savings ($15.43 saved/child treated). The cost/consultation was $11.6 and $9.6 in the standard and reduced arms, respectively, with RUTF accounting for 56.2% and 47.0% of the total. The savings/child treated was $11.4 in a scenario simulating the Burkinabè routine SAM treatment outside clinical trial settings. The reduced RUTF dose tested in the MANGO trial resulted in significant cost savings for SAM treatment. These results are useful for decision makers to estimate potential economic gains from an optimized SAM treatment protocol in Burkina Faso and similar contexts. [ABSTRACT FROM AUTHOR]

This study in Burkina Faso investigated whether offspring of young mothers who had received weekly periconceptional iron supplementation in a randomised controlled trial were at increased risk of malaria. A child safety survey was undertaken in the peak month of malaria transmission towards the end of the trial to assess child iron biomarkers, nutritional status, anaemia and malaria outcomes. Antenatal iron biomarkers, preterm birth, fetal growth restriction and placental pathology for malaria and chorioamnionitis were assessed. Data were available for 180 babies surviving to the time of the survey when their median age was 9 months. Prevalence of maternal iron deficiency in the last trimester based on low body iron stores was 16%. Prevalence of active placental malaria infection was 24.8%, past infection 59% and chorioamnionitis 55.6%. Babies of iron supplemented women had lower median gestational age. Four out of five children ≥ 6 months were iron deficient, and 98% were anaemic. At 4 months malaria prevalence was 45%. Child iron biomarkers, anaemia and malaria outcomes did not differ by trial arm. Factors associated with childhood parasitaemia were third trimester C‐reactive protein level (OR 2.1; 95% CI 1.1–3.9), active placental malaria (OR 5.8; 1.0–32.5, P = 0.042) and child body iron stores (OR 1.13; 1.04–1.23, P = 0.002). Chorioamnionitis was associated with reduced risk of child parasitaemia (OR 0.4; 0.1–1.0, P = 0.038). Periconceptional iron supplementation of young women did not alter body iron stores of their children. Higher child body iron stores and placental malaria increased risk of childhood parasitaemia. [ABSTRACT FROM AUTHOR]

School‐based healthy living interventions are widely promoted as strategies for preventing obesity. The peer‐led Healthy Buddies™ curriculum has been shown to improve obesity‐related outcomes in school‐aged children. We examined whether these improvements existed among subgroups of children stratified by sex, income level and urban/rural geography. In a cluster‐randomized controlled trial, elementary schools in Manitoba, Canada, were randomly allocated to Healthy Buddies™ (10 schools, 340 students) or standard curriculum (10 schools, 347 students). Healthy Buddies™ participants had 21weekly lessons on healthy eating, physical activity and self‐efficacy, delivered by children age 9–12 to children age 6–8. We assessed pre‐ and post‐intervention body mass index (BMI) z‐scores, waist circumference, healthy living knowledge, dietary intake and self‐efficacy among the younger children. Compared to standard curriculum (n = 154), Healthy Buddies™ participants (n = 157) experienced a greater reduction in waist circumference (−1.7 cm; 95% confidence interval [CI][−2.8, −0.5 cm]) and improved dietary intake (4.6; 95% CI [0.9, 8.3]), healthy living knowledge (5.9; 95% CI [2.3, 9.5]) and self‐efficacy (5.3; 95% CI [1.0, 9.5]) scores. In subgroup analyses, effects for waist circumference (−2.0 cm; 95% CI [−3.6, −0.5]), healthy living knowledge (9.1; 95% CI [4.4, 13.8]) and self‐efficacy (8.3; 95% CI [3.3, 13.3]) were significant among boys. Dietary intake (10.5; 95% CI [5.5, 15.4]), healthy living knowledge (9.8; 95% CI [4.5, 15.0]) and self‐efficacy (6.7; 95% CI [0.7, 12.7]) improved among urban‐dwelling but not rural‐dwelling children. Healthy Buddies™ was effective for boys and children living in urban settings. Enhanced curricula may be needed to improve program effectiveness for select subgroups of school‐aged children. [ABSTRACT FROM AUTHOR]

There are no guidelines for the optimal protein quality of ready‐to‐supplementary food (RUSF) for moderate acute malnutrition (MAM). This randomized, controlled, double‐blinded, clinical effectiveness trial evaluated two RUSFs in the treatment of MAM. Both foods contained greater than 7% dairy protein, but the protein‐optimized RUSF had a calculated digestible indispensable amino acid score (DIAAS) of 95%, whereas the control RUSF had a calculated DIAAS of 63%. There were 1,737 rural Malawian children 6–59 months of age treated with 75 kcal/kg/day of either control or protein quality‐optimized RUSF for up to 12 weeks. There was no difference in the proportion of children who recovered from MAM between the group that received protein‐optimized RUSF (759/860, 88%) and the group that received control RUSF (766/877, 87%, difference 1%, 95% CI, −2.1 to 4.1, p = 0.61). There were no differences in time to recovery or average weight gain; nor were adverse effects reported. Both RUSFs showed indistinguishable clinical outcomes, with recovery rates higher than typically seen in treatment for MAM. The DIAAS of these two RUSFs was measured using a pig model. Unexpectedly, the protein quality of the optimized RUSF was inferior to the control RUSF: DIAAS = 82% for the protein quality optimized RUSF and 96% for control RUSF. The controlled conditions of this trial suggest that in supplementary food products for MAM, protein quality is not an independent predictor of clinical effectiveness. [ABSTRACT FROM AUTHOR]

Childhood obesity has been associated with consumption of energy‐dense foods such as caloric beverages and fast foods. Many low‐ and middle‐income countries like Bangladesh are now experiencing a rising problem of noncommunicable diseases along with the long‐standing problem of stunting and undernutrition. WASH Benefits Bangladesh was a large community‐based cluster randomized controlled trial conducted in rural Bangladesh. Study clusters were randomized into seven arms: single nutrition (N); water (W); sanitation (S); hygiene (H); combined water, sanitation, and hygiene (WSH); WSH and nutrition (N + WSH); and a double sized control (C). Nutrition intervention messages included four promotional components: maternal nutrition, breastfeeding, complementary feeding, and lipid‐based nutrient supplements. The World Health Organization infant food frequency questionnaire (24‐hr recall and 7‐day recall) was administered at Year 1 and Year 2 of intervention. The likelihood of any snack food consumption was significantly lower (odds ratio 0.37: 95% confidence interval [0.28, 0.49]) in the nutrition intervention arms compared to the control arm in Year 2 follow‐up. In addition, in the water intervention arm, fewer children (about 50% less) consumed soft drinks, but not the other sugar‐sweetened beverages, compared with control in Year 2. There were no other differences between groups. Simple messages about balanced diet and feeding family foods were effective in lowering commercially produced snack food consumption of the young children in low‐income rural communities of Bangladesh. Provision of safe water apparently encouraged mothers to reduce offering unhealthy beverages to the young children. [ABSTRACT FROM AUTHOR]

Prenatal nutritional supplements may improve birth outcomes. This study aims to examine the effect of prenatal lipid‐based nutrient supplements (LNS), compared with iron and folic acid (IFA), on general newborn physical condition and feeding behaviours. We conducted a cluster‐randomized effectiveness trial that enrolled 4,011 pregnant women at ≤20 gestational weeks. LNS and IFA were provided to women in 48 and 16 clusters, respectively, for daily consumption until delivery. We collected data on household socio‐economic, food insecurity, and maternal characteristics during early pregnancy and on newborn condition and feeding within 72 hr of delivery. We analysed intervention effects on these secondary outcomes using mixed models with analysis of covariance for continuous outcomes and logistic regression for dichotomous outcomes. Among 3,664 live births, intervention groups did not differ in newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding in the first 24 hr. If the mother perceived her infant to be healthy, EIBF was more likely (OR [95% CI]: 2.08 [1.46, 2.97]) and frequency of breastfeeding in the first 24 hr was greater (mean difference [95% CI]: 3.0 [1.91, 4.01]), but there was no difference in exclusive breastfeeding in the first 24 hr. Newborn condition and early breastfeeding practices were not affected by giving mothers prenatal LNS versus IFA. However, early breastfeeding practices were related to maternal perception of her newborn's condition. Thus, interventions to improve breastfeeding practices for newborns with poorer perceived health status may be useful. [ABSTRACT FROM AUTHOR]

Abstract: Pregnant and post‐partum women require increased nutrient intake and optimal cognition, which depends on adequate nutrition, to enable reasoning and learning for caregiving. We aimed to assess (a) differences in maternal cognition and caregiving between women in Malawi who received different nutritional supplements, (b) 14 effect modifiers, and (c) associations of cognition and caregiving with biomarkers of iron, Vitamin A, B‐vitamin, and fatty acid status. In a randomized controlled trial (n = 869), pregnant women daily received either multiple micronutrients (MMN), 20 g/day lipid‐based nutrient supplements (LNS), or a control iron/folic acid (IFA) tablet. After delivery, supplementation continued in the MMN and LNS arms, and the IFA control group received placebo until 6 months post‐partum, when cognition (n = 712), caregiving behaviour (n = 669), and biomarkers of nutritional status (n = 283) were assessed. In the full group, only one difference was significant: the IFA arm scored 0.22 SD (95% CI [0.01, 0.39], p = .03) higher than the LNS arm in mental rotation. Among subgroups of women with baseline low hemoglobin, poor iron status, or malaria, those who received LNS scored 0.4 to 0.7 SD higher than the IFA arm in verbal fluency. Breastmilk docosahexaenoic acid and Vitamin B12 concentrations were positively associated with verbal fluency and digit span forward (adjusting for covariates ps < .05). In this population in Malawi, maternal supplementation with MMN or LNS did not positively affect maternal cognition or caregiving. Maternal docosahexaenoic acid and B12 status may be important for post‐partum attention and executive function. [ABSTRACT FROM AUTHOR]

Adding amylase to fortified blended foods can improve energy density, and increase child's energy and nutrient intake. The efficacy of this strategy is unknown for the World Food Programme's Super Cereal Plus (SC+) and Super Cereal (SC) blends. The primary goal of this study was to investigate the increased energy intake from amylase-containing SC+ and SC compared to control porridges in Burkinabe children. Secondly, energy intake from amylase-containing porridges compared to CERELAC®, Vitazom, and eeZeeBAR™ was studied. Thirdly, caregivers' ( n = 100) porridge acceptability was investigated. The design was a randomized double-blind controlled cross-over trial studying the effect of amylase addition to SC+ and SC flours on porridge energy and nutrient intake in healthy Burkinabe children aged 12-23 ( n = 80) and 24-35 months ( n = 40). Amylase added to porridges increased energy density from 0.68 to 1.16 kcal/g for SC+ and from 0.66 to 1.03 kcal/g for SC porridges. Among children aged 12-23 months, mean energy intake from all porridges with amylase (135-164 kcal/meal) was significantly higher compared to control SC+ porridges (84-98 kcal/meal; model-based average). Among children aged 24-35 months, mean energy intakes were also significantly higher from all porridges with amylase added (245-288 kcal/meal) compared to control SC porridges (175-183 kcal/meal). Acceptability of the porridges among caregivers was rated neutral to good, both for amylase-added and non-amylase-containing porridges. These findings suggest that, among 12-35-month-old, adding amylase to fortified blended foods significantly increased energy and consequently nutrient intake per meal by 67% for SC+ and 47% for SC. Moreover, amylase-containing porridges were well accepted by the caregivers. [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]

Prenatal supplementation with protein-energy (PE) and/or multiple-micronutrients (MMNs) may improve fetal growth, but trials of lipid-based nutritional supplements (LNSs) have reported inconsistent results. We conducted a post-hoc analysis of non-primary outcomes in a trial in Gambia, with the aim to test the associations of LNS with fetal growth and explore how efficacy varies depending on nutritional status. The sample comprised 620 pregnant women in an individually randomized, partially blinded trial with four arms: (a) iron and folic acid (FeFol) tablet (usual care, referent group), (b) MMN tablet, (c) PE LNS, and (d) PE + MMN LNS. Analysis of variance examined unadjusted differences in fetal biometry z-scores at 20 and 30 weeks and neonatal anthropometry z-scores, while regression tested for modification of intervention-outcome associations by season and maternal height, body mass index, and weight gain. Despite evidence of between-arm differences in some fetal biometry, z-scores at birth were not greater in the intervention arms than the FeFol arm (e.g., birth weight z-scores: FeFol −0.71, MMN −0.63, PE −0.64, PE + MMN −0.62; group-wise p = .796). In regression analyses, intervention associations with birth weight and head circumference were modified by maternal weight gain between booking and 30 weeks gestation (e.g., PE + MMN associations with birth weight were +0.462 z-scores (95% CI [0.097, 0.826]) in the highest quartile of weight gain but -0.099 z-scores (−0.459, 0.260) in the lowest). In conclusion, we found no strong evidence that a prenatal LNS intervention was associated with better fetal growth in the whole sample. [ABSTRACT FROM AUTHOR]

Strategies for preventing undernutrition comprise a range of interventions, including education, provision of complementary food and cash transfer. Here, we compared monthly distributions of two different lipid‐based nutrient supplements (LNS), large‐quantity LNS (LNS‐LQ) and medium‐quantity LNS (LNS‐MQ) for 15 months on prevention of undernutrition among children 6 to 23 months. Both groups also received cash transfer for the first 5 months of the intervention. We conducted a prospective intervention study in Maradi, Niger, between August 2011 and October 2012. Six and 11 villages were randomly allocated to LNS‐LQ/Cash and LNS‐MQ/Cash, respectively. Children measuring 60–80 cm were enrolled in the respective groups and followed up monthly. Poisson regression was used to assess differences between interventions and adjust for baseline characteristics, intervention periods and child‐feeding practices. The analysis included 2586 children (1081 in the LNS‐LQ/Cash group and 1505 in the LNS‐MQ/Cash group). This study suggests that provision of LNS‐LQ (reference) or LNS‐MQ had, overall, similar effect on incidence of severe acute malnutrition (RR = 0.97; 95% CI: 0.67–1.40; P = 0.88), moderate acute malnutrition (RR = 1.20; 95% CI: 0.97–1.48; P = 0.08), severe stunting (RR = 0.94; 95% CI: 0.70–1.26; P = 0.69), moderate stunting (RR = 0.95; 95% CI: 0.76–1.19; P = 0.67) and mortality (RR = 0.83; 95% CI: 0.41–1.65; P = 0.59). Compared with LNS‐LQ, LNS‐MQ showed a greater protective effect on moderate acute malnutrition among children with good dietary adequacy: RR = 0.72; 95% CI: 0.56–0.94; P = 0.01. These results highlight the need to design context‐specific programmes. Provision of LNS‐LQ might be more appropriate when food insecurity is high, while when food security is better, distribution of LNS‐MQ might be more appropriate. [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]

Few trials have shown that promoting complementary feeding among young children is effective in improving child linear growth in resource‐challenged settings. We designed a community‐based participatory nutrition promotion (CPNP) programme adapting a Positive Deviance/Hearth approach that engaged mothers in 2‐week nutrition sessions using the principles of ‘learning by doing’ around child feeding. We aimed to test the effectiveness of the CPNP for improving child growth in rural Ethiopia. A cluster randomized trial was implemented by adding the CPNP to the existing government nutrition programmes (six clusters) vs. government programmes only (six clusters). A total of 1790 children aged 6 to 12 months (876 in the intervention and 914 in the control areas) were enrolled and assessed on anthropometry every 3 months for a year. Multi‐level mixed‐effect regression analysis of longitudinal outcome data (n = 1475) examined the programme impact on growth, adjusting for clustering and enrollment characteristics. Compared with children 6 to 24 months of age in the control area, those in the intervention area had a greater increase in z scores for length‐for‐age [difference (diff): 0.021 z score/month, 95% CI: 0.008, 0.034] and weight‐for‐length (diff: 0.042 z score/month, 95% CI: 0.024, 0.059). At the end of the 12‐month follow‐up, children in the intervention area showed an 8.1% (P = 0.02) and 6.3% (P = 0.046) lower prevalence of stunting and underweight, respectively, after controlling for differences in the prevalence at enrollment, compared with the control group. A novel CPNP programme was effective in improving child growth and reducing undernutrition in this setting. © 2016 John Wiley & Sons Ltd [ABSTRACT FROM AUTHOR]

Objective To estimate the placebo effect in juvenile idiopathic arthritis ( JIA) through a meta-analysis of phase III clinical trials with placebo comparator. Methods A systematic literature search was carried out up to December 2014. For parallel design studies the outcome was evaluated as a single 1-dimensional (1-D) variable or as a composite score; outcomes of withdrawal studies were evaluated only as composite scores. Results We included 26 of 224 trials (12%). In trials with parallel study design and a 1-D outcome, the placebo effect was 0.35 (95% confidence interval [95% CI] 0.27-0.43). Among trials with parallel study design and a composite score outcome, the placebo rate response was higher in trials that included patients with nonsystemic JIA (0.35 [95% CI 0.29-0.42]) than in trials that included only patients with systemic JIA (0.17 [ 95% CI 0.10-0.30]). In the withdrawal design trials, the percentages of patients receiving placebo who had disease flares during the double-blind phase were lower in trials that included patients with nonsystemic JIA (0.55 [ 95% CI 0.47-0.64]) than in trials that included only patients with systemic JIA (0.68 [95% CI 0.33-0.90]). Conclusion In trials with a parallel study design a sizable number of patients seem to benefit from a placebo effect, although this effect is smaller in patients with systemic JIA. In trials with a withdrawal design the inverse placebo effect is similar among the different JIA categories. This placebo effect should be considered when evaluating the effectiveness of proposed interventions and for future calculations of sample size. [ABSTRACT FROM AUTHOR]

Nutrition interventions have an effect on growth, energy and nutrient intake, and development, but there are mixed reports on the effect of supplementation of energy‐dense foods on dietary intake. This substudy aimed at assessing the effect of supplementation with corn–soy blend (CSB) or lipid‐based nutrient supplement (LNS) on energy and nutrient intake in moderately underweight children participating in a clinical trial. A total of 188 children aged 8–18 months participated and received daily either 284 kcal from CSB or 220 kcal from LNS and no supplements (control). An interactive 24‐h recall method was used to estimate energy and nutrient intakes in the groups. Total mean energy intake was 548 kcal, 551 kcal and 692 kcal in the control, CSB and LNS groups, respectively (P = 0.011). The mean (95% confidence interval) intake of energy and protein were 144 (37–250; P < 0.001) and 46 (1.5–7.6; P < 0.001) larger, respectively, in the LNS group than among the controls. No significant differences were observed between the control and CSB groups. Energy intake from non‐supplement foods was significantly lower in the CSB group compared with the control group, but not in the LNS group, suggesting a lower displacement of non‐supplement foods with LNS. Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001). This study indicates that LNS might be superior to CSB to supplement underweight children as it results in higher energy intake, but this requires confirmation in other settings. [ABSTRACT FROM AUTHOR]

Anaemia affects 46% of preschool‐aged children in Nepal. A cluster‐randomised study was conducted in rural Nepal to test whether providing micronutrient powders (MNP) in addition to enhanced homestead food production (EHFP) programme, consisting of home gardens, poultry and nutrition education, could lead to a higher reduction in anaemia compared with providing only EHFP. This sub‐study enrolled 335 children aged 6–9 months into one of three groups: (1) EHFP + MNP; (2) EHFP; or (3) control. The EHFP + MNP group received 60 sachets of MNP for flexible consumption at the start and 6 months later for a total supplementation period of 11 months. The MNP contained 15 micronutrients including iron (10 mg encapsulated ferrous fumarate). Haemoglobin and anthropometry were measured at baseline and post‐MNP supplementation. Mean ± SE haemoglobin concentration increased significantly in all groups, with a slightly higher but non‐significant increase in the EHFP + MNP and EHFP compared with control (difference‐in‐differences: 4.1 g L−1 for EHFP + MNP vs. control; 3.6 g L−1 for EHFP vs. control; 0.5 g L−1 for EHFP + MNP vs. EHFP). Anaemia decreased at a slightly higher magnitude in the EHFP + MNP [51.5 percentage points (PP)] than the EHFP (48.6 PP) and control (39.6 PP), with adjusted odds ratios (95% CI) at post‐supplementation of 0.52 (0.25–1.12) for EHFP + MNP and 0.69 (0.35–1.36) for EHFP, compared with control. There was no impact on child growth. Combining EHFP and MNP programmes yielded a marginally significant reduction in anaemia among children. [ABSTRACT FROM AUTHOR]

As pregnancy may trigger overweight in women, new means for its prevention are being sought. The aim here was to investigate the effect of individual dietary counselling during and after pregnancy on post‐partum weight and waist circumference up to 4 years post‐partum. A cohort of women (n = 256) were randomized to receive repeated individual dietary counselling by a nutritionist during and after pregnancy, or as controls not receiving dietary counselling, from the first trimester of pregnancy until 6 months after delivery. Counselling aimed to bring dietary intake into line with recommendations, with particular focus on the increase in the intake of unsaturated fatty acids instead of saturated. Pre‐pregnancy weight was taken from welfare clinic records. Weight and waist circumference were measured at 4 years after delivery. The proportion of overweight women increased from 26% prior to pregnancy to 30% at 4 years after delivery among women receiving dietary counselling, as against considerably more, from 32% to 57%, among controls. The prevalence of central adiposity was 31% in women receiving dietary counselling, 64% in controls. Likewise, both the risk of overweight (odds ratio: 0.23, 0.08–0.63, P = 0.005) and central adiposity (odds ratio: 0.18, 0.06–0.52, P = 0.002) were lower in women receiving dietary counselling compared with controls. Repeated dietary counselling initiated in early pregnancy can be beneficial in long‐term weight control after delivery. [ABSTRACT FROM AUTHOR]

Background Venous leg ulcers are a common and distressing condition that can impair quality of life. Larval therapy has been widely promoted for the treatment of different types of chronic wounds, yet little is known about its acceptability to patients. Objectives To explore patients' experiences of venous leg ulceration and of the acceptability of larval therapy as a treatment. Design Qualitative study, using semi-structured interviews alongside a randomized controlled trial. Interview data were transcribed and analysed for thematic content. Data were collected from April 2007 to July 2007. Setting and participants Eighteen people (12 men, 6 women), aged between 29 and 93 years (median age 64 years), with at least one venous leg ulcer, took part in the study. Fourteen people were recruited from two vascular clinics (one attached to a hospital and the other located in a community setting). A further four people were recruited through referral from a team of community nurses. Findings Participants portrayed lives blighted by the presence of one or more leg ulcers. The majority were willing to try 'maggots' (larvae) and able to overcome feelings of squeamishness because of their strong desire to heal their ulcers. Five people treated with larvae were included in the study. Initial improvements in the condition of their ulcers were not sustained, and two participants experienced severe pain. Discussion and conclusions Patients may hold unrealistic expectations that larval therapy will effect a longed-for cure for their leg ulcer(s) but an absence of healing may lead to feelings of disappointment or despair. [ABSTRACT FROM AUTHOR]

Growth patterns in early life are associated with later health. The effect of nutrition during in utero development on later body composition is unclear. We evaluated whether prenatal early invitation to food and/or multiple micronutrient supplementation ( MMS) in pregnancy has an effect on offspring body composition at 54 months of age. In Maternal and Infant Nutrition Interventions in Matlab trial ( ISRCTN16581394) in Bangladesh, 4436 pregnant women were randomised into six equally sized groups: double-masked supplementation with capsules of either 30 mg Fe and 400 μg folic acid, or 60 mg Fe and 400 μg folic acid, or MMS (15 micronutrients), was combined with a randomised early invitation (around 9 weeks) or a usual invitation (around 20 weeks) to start food supplementation (608 kcal 6 days per week). At 54 months, the body composition of the offspring was assessed by leg-to-leg bioelectrical impedance analysis. Of the 3267 live singletons with birth anthropometry, 2290 children were measured at 54 months, representing 70% of the live births. There was no interaction between the food and micronutrient supplementation on body composition outcomes. There were no significant differences in a range of anthropometric and body composition measurements, including weight, height, mid-upper arm circumference, head circumference, skinfold thickness, and fat mass and fat-free mass between the different prenatal food and micronutrient groups using an intention-to-treat analysis. This analysis shows that early invitation to food supplementation and MMS provided to rural Bangladeshi women during pregnancy did not affect offspring body composition at 54 months of age. [ABSTRACT FROM AUTHOR]

Multivitamin supplementation has been shown to reduce the risk of low birthweight. This effect could be mediated through gestational weight gain. However, the effect of multivitamin supplementation on weight gain during pregnancy has not been fully studied. The objective of this study was to examine the effects of multivitamins on pregnancy weight gain. We enrolled 8468 HIV-negative women from Dar es Salaam, Tanzania, in a randomised, placebo-controlled trial of multivitamins on birth outcomes. Women were randomly assigned to receive either a daily oral dose of multivitamin tablets or a placebo and were weighed every 4 weeks from enrolment until the last visit before delivery. Intent-to-treat analyses were carried out to examine the effects of multivitamins on pregnancy weight gain. Multivariate linear and binomial regression models with the log-link function were used to examine the association of weight gain during pregnancy to birthweight. The overall total weight gain was 253 g ( SE: 69, P: 0.0003) more, while the overall 4 weekly weight gain was 59 g greater ( SE: 18, P: 0.005) among women who received multivitamins compared to placebo. Women in the lowest quartile of gestational weight gain had babies with an average birthweight of 3030 g ( SD: 524), while women in the highest quartile had babies weighing 3246 g ( SD: 486), on average. Prenatal multivitamin supplements increased gestational weight gain, which was a significant predictor of birthweight. [ABSTRACT FROM AUTHOR]

Background Patient preference for the choice of treatment modality for prostate cancer has increasingly gained attention. Objective To assess the impact of client-oriented decision on long-term mortality, disease progression and biochemical failure compared with standard treatment protocol ( TP). Methods With data from a Finnish multicentre, randomized controlled trial with two arms [104 in the enhanced patient participation ( EPP) arm and 106 in the TP arm], disease-specific and disease-free survival, biochemical failure with elevated prostate-specific antigen ( PSA) level and disease progression were compared between the two arms using Wilcoxon test and also Cox proportional hazards regression model. Results Patients in the EPP arm had a higher risk of death by 37% [ HR, 1.37 (0.87-2.17)] compared with those in the TP arm. Patients in the EPP arm were at increased risk of having biochemical failure by 14% [ HR, 1.14 (0.72-1.79)] and for having disease progression by 2% [ HR, 1.02 (0.61-1.70)] compared with those in the TP arm. All the differences were non-significant. Conclusions Patients actively involved in the choice of treatment had higher risk of prostate cancer death but only slightly increased risk of biochemical failure and clinical disease progression. These findings would provide a good reference when patient autonomy for the choice of treatment modality is addressed. [ABSTRACT FROM AUTHOR]

A systematic review and meta-analysis of available randomised controlled trials ( RCTs) was conducted to evaluate the effect of zinc ( Zn) intake on serum/plasma Zn status in infants. Out of 5500 studies identified through electronic searches and reference lists, 13 RCTs were selected after applying the exclusion/inclusion criteria. The influence of Zn intake on serum/plasma Zn concentration was considered in the overall meta-analysis. Other variables were also taken into account as possible effect modifiers: doses of Zn intake, intervention duration, nutritional status and risk of bias. The pooled β of status was 0.09 [confidence interval ( CI) 0.05 to 0.12]. However, a substantial heterogeneity was present in the analyses (I2 = 98%; P = 0.00001). When we performed a meta-regression, the effect of Zn intake on serum/plasma Zn status changed depending on the duration of the intervention, the dose of supplementation and the nutritional situation ( P ANCOVA = 0.054; <0.001 and <0.007, respectively). After stratifying the sample according to the effect modifiers, the results by duration of intervention showed a positive effect when Zn intake was provided during medium and long periods of time (4-20 weeks and >20 weeks). A positive effect was also seen when doses ranged from 8.1 to 12 mg day−1. In all cases, the pooled β showed high evidence of heterogeneity. Zn supplementation increases serum/plasma Zn status in infants, although high evidence of heterogeneity was found. Further standardised research is urgently needed to reach evidence-based conclusions to clarify the role of Zn supplementation upon infant serum/plasma Zn status, particularly in Europe. [ABSTRACT FROM AUTHOR]

Inadequate feeding and care may contribute to high rates of stunting and underweight among children in rural families in India. This cluster-randomized trial tested the hypothesis that teaching caregivers appropriate complementary feeding and strategies for how to feed and play responsively through home-visits would increase children's dietary intake, growth and development compared with home-visit-complementary feeding education alone or routine care. Sixty villages in Andhra Pradesh were randomized into three groups of 20 villages with 200 mother-infant dyads in each group. The control group (CG) received routine Integrated Child Development Services (ICDS); the complementary feeding group (CFG) received the ICDS plus the World Health Organization recommendations on breastfeeding and complementary foods; and the responsive complementary feeding and play group (RCF&PG) received the same intervention as the CFG plus skills for responsive feeding and psychosocial stimulation. Both intervention groups received bi-weekly visits by trained village women. The groups did not differ at 3 months on socioeconomic status, maternal and child nutritional indices, and maternal depression. After controlling for potential confounding factors using the mixed models approach, the 12-month intervention to the CFG and RCF&PG significantly ( P < 0.05) increased median intakes of energy, protein, Vitamin A, calcium (CFG), iron and zinc, reduced stunting [0.19, confidence interval (CI): 0.0-0.4] in the CFG (but not RCF&PG) and increased ( P < 0.01) Bayley Mental Development scores (mean = 3.1, CI: 0.8-5.3) in the RCF&PG (but not CFG) compared with CG. Community-based educational interventions can improve dietary intake, length (CFG) and mental development (RCF&PG) for children under 2 years in food-secure rural Indian families. [ABSTRACT FROM AUTHOR]

Inappropriate complementary feeding practices have led to, in part, significant disparities in growth and nutritional status between rural and urban children in China. A cluster-randomised, controlled trial was implemented in Laishui, China to assess the effectiveness of an educational intervention on caregivers' feeding practices and children's growth. Eight townships were randomly assigned to the intervention or control. Five hundred ninety-nine healthy infants were enrolled at 2-4 months old, and were followed up at ages 6, 9, 12, 15 and 18 months. The intervention group received information on enhanced home-prepared recipes and food preparation and hygiene through group training, counselling and home visit. Key outcomes were children's physical growth, caregivers' knowledge and behaviours on complementary feeding, and the infant and child feeding index ( ICFI). Analysis was by intention to treat. The intervention group achieved better knowledge and practices related to complementary feeding, and significantly higher ICFI scores at each follow-up point. Children in the intervention group achieved higher z-scores for weight-for-age ( WAZ) and weight-for-height ( WHZ) than the control (0.18 vs. 0.01 and 0.49 vs. 0.19, respectively) at 18 months old, and were less likely to have stunted growth (odds ratio = 0.71, 95% confidence interval: 0.53-0.94). Mixed model showed that the intervention group achieved significantly better linear growth over time, including WAZ ( P = 0.016), WHZ ( P = 0.030) and HAZ ( P = 0.078). These results indicated that an educational intervention delivered through local health services can enhance caregivers' knowledge and practices of complementary feeding and ultimately improve children's growth. [ABSTRACT FROM AUTHOR]

Background Behavioural change interventions for persons with chronic illness draw on a variety of theoretical approaches including motivational interviewing and shared decision making. Health literacy provides an additional, potentially powerful explanatory framework to guide research and practice. Objective To examine the changes in the depth and detail of diabetes-related knowledge and confidence for persons with type 2 diabetes. Design Two-year, prospective, observational study, using questionnaire data at two time points (baseline and 2 years later) and in-depth interviews with a theoretically selected subsample. Setting and participants A total of 319 patients initially recruited from a deprived urban area in north-west England Intervention Dedicated tele-carer education and support, tailored to the individual circumstances of the patient. Main outcome measures Perceptions of confidence, levels of empowerment, learning for self-care and most helpful aspects of the intervention. Results Over 90% expressed confidence in keeping their blood sugar controlled, and high levels of perceived empowerment (mean = 4.25; 95% CI, 4.17-4.33) were found. Changes in the depth and detail of diabetes-related knowledge and confidence, from the specific to the more general, were observed and enhanced competence in translating knowledge into practice. Discussion and conclusions The intervention, built within a developed working partnership between tele-carer and patient, operated at two levels: health literacy, enhancing knowledge, developing personal skills and enabling self-control; and socio-psychological behavioural change, tailored to individuals within their socio-economic environments, enabling increased motivation and supportive problem-solving. Both approaches find reflection in the findings and provide powerful explanatory lenses to interrogate the data. [ABSTRACT FROM AUTHOR]

Objectives: The objective was to assess the feasibility of insulin infusion and subcutaneous insulin administered in the prehospital setting and their relative effect on hyperglycemia, a predictor of unfavorable outcome, in acute stroke patients. Methods: Hyperglycemic patients (plasma glucose >6.0 mmol/ L) with stroke symptoms were randomized prior to or during transport to the hospital to receive either 1) a single subcutaneous dose of shortacting insulin (n = 11) or 2) a continuous intravenous (IV) insulin infusion (n = 12) at a rate adjusted by glucose levels measured every 10 minutes and targeted to plasma glucose 4.5-6.0 mmol / L. The changes in plasma glucose concentration were compared with a nonrandomized control group (n = 38) receiving standard care. Results: The baseline characteristics did not differ between the study groups. Plasma glucose concentration was significantly decreased during the prehospital phase in the IV-treated group in comparison to the control group (difference between groups -1.9 mmol / L, 95% confidence interval [CI] = -3.5 to -0.27) with no serious adverse events. In contrast, subcutaneous insulin did not achieve significant lowering of plasma glucose (-0.9 mmol/ L, 95% CI = -2.4 to 0.6). Conclusions: This small sample suggests that adjusted insulin infusion efficiently lowers blood glucose in the ultra-acute phase of stroke and is feasible in the prehospital setting. [ABSTRACT FROM AUTHOR]

Experts estimate that the prevalence of antibiotics use exceeds the prevalence of bacterial acute respiratory infections (ARIs). To develop, adapt and validate DECISION+ and estimate its impact on the decision of family physicians (FPs) and their patients on whether to use antibiotics for ARIs. Two-arm parallel clustered pilot randomized controlled trial. Four family medicine groups were randomized to immediate DECISION+ participation (the experimental group) or delayed DECISION+ participation (the control group). Thirty-three FPs and 459 patients participated. DECISION+ is a multiple-component, continuing professional development program in shared decision making that addresses the use of antibiotics for ARIs. Throughout the pilot trial, DECISION+ was adapted in response to participant feedback. After the consultation, patients and FPs independently self-reported the decision (immediate use, delayed use, or no use of antibiotics) and its quality. Agreement between their decisional conflict was assessed. Two weeks later, patients assessed their decisional regret and health status. Compared to the control group, the experimental group reduced its immediate use of antibiotics (49 vs. 33% absolute difference = 16%; P = 0.08). Decisional conflict agreement was stronger in the experimental group (absolute difference of Pearson's r = 0.26; P = 0.06). Decisional regret and perceptions of the quality of the decision and of health status in the two groups were similar. DECISION+ was developed successfully and appears to reduce the use of antibiotics for ARIs without affecting patients' outcomes. A larger trial is needed to confirm this observation. [ABSTRACT FROM AUTHOR]

The UK has low breastfeeding rates, with socioeconomic disparities. The Assets‐based feeding help Before and After birth (ABA) intervention was designed to be inclusive and improve infant feeding behaviours. ABA is underpinned by the behaviour change wheel and offers an assets‐based approach focusing on positive capabilities of individuals and communities, including use of a Genogram. This study aimed to investigate feasibility of intervention delivery within a randomised controlled trial (RCT). Nulliparous women ≥16 years, (n = 103) from two English sites were recruited and randomised to either intervention or usual care. The intervention – delivered through face‐to‐face, telephone and text message by trained Infant Feeding Helpers (IFHs) – ran from 30‐weeks' gestation until 5‐months postnatal. Outcomes included recruitment rates and follow‐up at 3‐days, 8‐weeks and 6‐months postnatal, with collection of future full trial outcomes via questionnaires. A mixed‐methods process evaluation included qualitative interviews with 30 women, 13 IFHs and 17 maternity providers; IFH contact logs; and fidelity checking of antenatal contact recordings. This study successfully recruited women, including teenagers, from socioeconomically disadvantaged areas; postnatal follow‐up rates were 68.0%, 85.4% and 80.6% at 3‐days, 8‐weeks and 6‐months respectively. Breastfeeding at 8‐weeks was obtained for 95.1% using routine data for non‐responders. It was possible to recruit and train peer supporters to deliver the intervention with adequate fidelity. The ABA intervention was acceptable to women, IFHs and maternity services. There was minimal contamination and no evidence of intervention‐related harm. In conclusion, the intervention is feasible to deliver within an RCT, and a definitive trial required. [ABSTRACT FROM AUTHOR]

Poor infant and young child feeding (IYCF) practices are associated with linear growth faltering. Our objective was to evaluate the impact of a nutrition and water and sanitation for health intervention on three IYCF indicators—minimum dietary diversity (MDD), minimum meal frequency (MMF), and minimum acceptable diet (MAD) in Kenyan children. Households were randomized into one of eight groups: (a) active control; (b) passive control; (c) water quality (W); (d) sanitation (S); (e) handwashing (H); (f) combined Water, Sanitation, and Handwashing; (g) nutrition (N); and (h) combined WSH + N. In the N and WSH + N arms, community‐based promoters counselled households on optimal IYCF practices, and small‐quantity lipid‐based nutrient supplements (SQ‐LNS) were provided to children 6–24 months of age. Twelve months (Year 1) and 24 months (Year 2) after interventions began, enumerators surveyed mothers to ascertain IYCF practices. We made pairwise comparisons of each intervention arm versus the active control arm using log binomial models. In total, 3,652 caretakers were surveyed at Year 1 and 4,987 caretakers at Year 2. Compared with the active control, there were no differences in any of the arms in MDD, MMF, or MAD, aside from an increase in MDD at Year 1 in the nutrition only arm but not in the combined WSH + N arm (N: 68%; WSH + N: 61%; C: 61%; N arm prevalence ratio: 1.13 95% CI [1.01, 1.25]). In this setting, a nutrition behaviour change communication intervention had little impact on IYCF indicators. The provision of SQ‐LNS was not detrimental to current IYCF indicators in the community. [ABSTRACT FROM AUTHOR]