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To synthesize results of six controlled trials of self-care interventions for depression and/or anxiety, focusing on five trials in which lay guidance was compared to self-directed use of the same self-care tools. The trials were conducted in Canada in different target populations. Self-care tools were adapted to each population. Guidance was provided in 3–15 calls over a period of 6–26 weeks. Depression and/or anxiety were assessed at follow-up (6–26 weeks). Pooled analyses used a meta-analytic approach. Engagement with the self-care tools was compared using the standardized difference or Cohen's d effect size. In studies with homogeneous outcomes (three for depression, four for anxiety), the pooled effect sizes of guidance vs. self-directed use of the self-care tools were 0.36 (95% CI 0.10, 0.62, N = 235) for depression and 0.21 (95% CI -0.03, 0.44, N = 285) for anxiety. Guidance consistently led to greater engagement with the tools. The intervention model is a potentially sustainable and accessible alternative to professionally guided self-care for people with mild-moderate depression. Factors which may have limited implementation success include: co-interventions, reduced number of guide calls (3 vs 6 or more), and delivery to dyads (patient-caregiver). [ABSTRACT FROM AUTHOR]

Background Probiotics may alleviate lactose maldigestion. Objectives The objective was to select a probiotic with high lactase activity and compare it with lactase and placebo in clinical trials. Methods Bacterial cultures were screened for lactase activity in a model of the upper gastrointestinal (GI) tract. Bifidobacterium animalis subsp. lactis Bi-07 (Bi-07) counts were adjusted in subsequent experiments to correspond to 4500 Food Chemicals Codex (FCC) units of lactase, the amount in the European Food Safety Authority (EFSA)-approved health claim. Two crossover clinical trials, Booster Alpha and Booster Omega, were performed in participants with lactose intolerance, where 2 × 1012 CFUs Bi-07, 4662 FCC lactase, or placebo was consumed simultaneously with a lactose challenge, with 1-wk washouts between challenges. The trial designs were identical except for the source of lactose. Breath hydrogen concentration (BHC) was measured to assess the effect of the investigational products on lactose digestion, for which incremental area under the curve (iAUC) was the primary outcome. Peak BHC, cumulative BHC, and GI symptoms were secondary outcomes. Results Bi-07 was superior to placebo in reducing BHC [iAUC, parts per million (ppm) ∙ h] in both trials (Booster Alpha: geometric least square mean ratio: 0.462; 95% CI: 0.249, 0.859; P =  0.016; Booster Omega: 0.227; 95% CI: 0.095, 0.543; P  = 0.001). Lactase was superior to placebo in Booster Alpha (0.190; 95% CI: 0.102, 0.365; P  < 0.001) but not Booster Omega (0.493; 95% CI: 0.210, 1.156; P  = 0.102). Noninferiority of Bi-07 compared with lactase was observed in Booster Omega (0.460; 95% CI: 0.193, 1.096; P  = 0.079; CI upper limit < 1.25 noninferiority margin). Odds of abdominal pain (compared with placebo: 0.32, P  = 0.036) and flatulence (compared with placebo: 0.25, P  = 0.007) were lower with lactase in Booster Alpha. Increased odds of nausea were seen with Bi-07 (compared with placebo: 4.0, P  = 0.005) in Booster Omega. Conclusions Bi-07 has high lactase activit y , and in 2 clinical trials, it supported lactose digestion in individuals with lactose intolerance. These trials were registered at clinicaltrials.gov as NCT03659747 (Booster Alpha) and NCT03814668 (Booster Omega). [ABSTRACT FROM AUTHOR]

Background The obesogenic environment of Western countries raises questions about its current management. Some clinical studies have explored hypnosis, although the current state of knowledge does not lead to definitive conclusions about its efficacy. Objectives We assessed the impact of Ericksonian hypnosis and self-hypnosis on disinhibition of eating in adults with obesity and high food impulsivity levels, compared with standard nutritional education. Methods From September 2014 to July 2015, adults with BMI (in kg/m2) of 30–40 and a high disinhibition score [>8 on the Three Factor Eating Questionnaire (TFEQ-51)] were included in a randomized controlled trial. The control and hypnosis groups received the same standard nutrition education in 8 workshops. In the hypnosis group, subjects had 8 sessions of hypnosis combined with training in self-hypnosis. Disinhibition (primary outcome) and other scores from the TFEQ-51 as well as anthropometric, food intake, cardiometabolic, and physical activity variables were collected at inclusion and at 8 mo. Results Of 82 randomly assigned adults, 70 participated in all sessions; 80 participated in ≥1 session and were included in the main analysis (hypnosis group, n  = 41; control group, n  = 39). After 8 mo of follow-up, disinhibition scores adjusted for baseline values were lower in the hypnosis group, with a mean between-group difference of 4.2 (95% CI: 2.8, 5.5; P  < 0.001); 67.7% of adults in the hypnosis group had normalized their disinhibition (compared with 11.1% in control; P  < 0.0001). Differences for weight (1.8 kg; 95% CI: −0.1, 3.7 kg; P  = 0.052), BMI (0.8; 95% CI: 0.1, 1.4; P  = 0.028), susceptibility to hunger score (2.2; 95% CI: 1.0, 3.3; P  < 0.001), and its 2 subscales also favored the hypnosis group. Conclusions In the management of adults with obesity and a high disinhibition score, hypnosis and self-hypnosis can significantly improve the deep mechanisms of eating behaviors and seem to have a beneficial effect on weight loss. This trial was registered at clinicaltrials.gov as NCT02292108. [ABSTRACT FROM AUTHOR]

Background Maternal vitamin D status during pregnancy and lactation is a modifiable factor that may influence offspring musculoskeletal outcomes. However, few randomized trials have tested the effects of prenatal or postpartum vitamin D supplementation on offspring bone and muscle development. Objectives The aim was to examine hypothesized effects of improvements in early-life vitamin D status on childhood musculoskeletal health in Dhaka, Bangladesh. Methods In a previously completed, double-blind, dose-ranging trial, healthy pregnant women (n  = 1300) were recruited at 17–24 weeks' gestation and randomly assigned to a prenatal/postpartum regimen of 0/0, 4200/0, 16,800/0, 28,000/0, or 28,000/28,000 IU cholecalciferol (vitamin D3)/wk until 26 wk postpartum. In this new report, we describe additional follow-up at 4 y of age (n  = 642) for longer-term outcomes. Bone mineral content (BMC) and areal bone mineral density (aBMD) were measured by DXA. Grip strength was tested using a hand-held dynamometer. The primary comparison was children of women assigned to 28,000 IU/wk prenatally compared with placebo. Differences are expressed as means and 95% CIs. Results Total-body-less-head (TBLH) BMC, TBLH aBMD, and grip strength were similar in the combined high-dose prenatal (28,000/0 and 28,000/28,000 IU/wk) compared with placebo groups (mean difference [95% CI] = 0.61 g [–10.90, 12.13], 0.0004 g/cm2 [–0.0089, 0.0097], and 0.02 kg [–0.26, 0.31], respectively). In dose-ranging analyses, TBLH BMC and aBMD, whole-body BMC and aBMD, and grip strength in each of the prenatal vitamin D groups were not significantly different from placebo (P  > 0.05 for all comparisons). Only head aBMD was greater in children of women assigned to the 28,000/28,000-IU regimen compared with placebo (mean difference [95% CI] = 0.024 g/cm2 [0.0009, 0.047], P  = 0.042); the effect was attenuated upon adjustment for child height, weight, and sex (P  = 0.11). Conclusions Maternal prenatal, with or without postpartum, vitamin D supplementation does not improve child BMC, aBMD, or grip strength at 4 y of age. The MDIG trial and present follow-up study were registered prospectively at www.clinicaltrials.gov as NCT01924013 and NCT03537443, respectively. [ABSTRACT FROM AUTHOR]

Background A large proportion of infants in low- and middle-income countries are stunted. These infants are often fed complementary foods that are low-quality, primarily in terms of protein and micronutrients. Objectives We aimed to test 2 milk–cereal mixes supplemented with modest and high amounts of protein during 6–12 mo of age, compared with no supplementation, for their effect on length-for-age z score (LAZ) at 12 mo of age. Methods Eligible infants (6 mo plus ≤29 d) were randomly assigned to either of the 2 interventions (modest- and high-protein) or a no supplement group. The milk–cereal mixes provided ∼125 kcal, 30%–45% energy from fats, and 80%–100% RDA of multiple micronutrients (MMN). The modest-protein group received 2.5 g protein [protein energy ratio (PER): 8%; 0.75 g from milk source] and the high-protein group received 5.6 g protein (PER: 18%, 1.68 g from milk source). One packet was given daily for 180 d. Counseling on continued breastfeeding and optimal infant-care practices was provided to all. Results We enrolled 1548 infants (high-protein: n  = 512; modest-protein: n  = 519; and no supplement: n  = 517). Compared with the no supplement group, there was an improvement in LAZ [adjusted mean difference (MD): 0.08; 95% CI: 0.01, 0.15], weight-for-age z score (MD: 0.12; 95% CI: 0.06, 0.19), weight-for-length z score (MD: 0.11; 95% CI: 0.02, 0.19), and midupper arm circumference z score (MD: 0.10; 95% CI: 0.02, 0.18) in the high-protein group at 12 mo of age. No significant differences for these anthropometric indicators were noted between the modest-protein and no supplement groups or between the high- and modest-protein groups. Conclusions Cereal mixes with higher amounts of milk-based protein and MMN may lead to improvement in linear growth and other anthropometric indexes in infants, compared with no supplementation. This trial was registered at ctri.nic.in as CTRI/2018/04/012932. [ABSTRACT FROM AUTHOR]

• We will monitor compliance with the intervention and adverse events. • Data will be analyzed following intention-to-treat principles. • A cost-effectiveness analysis will be performed. This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. This paper will provide a detailed description of the planned analyses for the TOPS trial. Australian New Zealand Clinical Trials Registry (ACTRN12615000939594). [ABSTRACT FROM AUTHOR]

• There is a lack of information about the effectiveness of foot-ankle muscle strengthening program on pain and functioning in people with KOA. • An 8-week foot-ankle muscle strengthening program decreased knee pain and enhanced physical function in individuals with KOA, presenting a potential to be clinically meaningful. • Foot-ankle muscle strengthening program can be a treatment option for individuals with knee osteoarthritis (KOA) who do not tolerate exercises with excessive load on the knee. Foot-ankle exercises could improve pain and function of individuals with KOA and need to be tested. To investigate whether an 8-week foot-ankle muscle strengthening program is effective for individuals with KOA to reduce pain and improve function. In this randomized controlled trial, individuals diagnosed with clinical and radiographic KOA were randomized into the intervention (supervised foot-ankle strengthening exercise program three times a week for 8 weeks) or control (usual care and recommendations of the healthcare team) group. Effectiveness was assessed by changes in clinical and functional outcomes between baseline and 8 weeks with pain as the primary outcome. ANCOVA tests using the intervention group as a reference and sex, body mass index, and baseline values as covariates assessed between-group differences. The intervention group showed lower pain scores (−4.4 units; 95%CI = −7.5, −1.1), better function (−7.1 units; 95%CI = −12.7, −1.4), higher total functional score (−11.9 units; 95%CI = −20.7, −3.1), with confidence intervals indicating a potential for the differences to be clinically meaningful, and better scores for the 30-s chair stand test (2.7 repetitions; 95%CI = 1.1, 4.1), with a confidence interval indicating a moderate clinically meaningful difference, compared to the controls. The 8-week foot-ankle exercise program showed positive, and potentially clinically meaningful, effects on knee pain and physical function among individuals with KOA, when compared to usual care. NCT04154059. https://clinicaltrials.gov/ct2/show/NCT04154059 [ABSTRACT FROM AUTHOR]

Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs). A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group. A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week. All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD. Secondary outcomes: physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences. Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P =.007; and Trail Making Test part A (TMT-A): r = −28.98, 95% CI: −54.89, −3.08, P =.029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = −1.86, 95% CI: −3.56, −0.17, P =.031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = −3.30, 95% CI: −6.57, −0.03, P =.048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P =.005). Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation. [ABSTRACT FROM AUTHOR]