Dataset Information

STRIDE: a randomized trial of a lifestyle intervention to promote weight loss among individuals taking antipsychotic medications.

ABSTRACT:

Background

Individuals diagnosed with serious mental illnesses are at increased risk of obesity- and cardiovascular-related morbidity and early mortality. Lifestyle interventions aimed at weight loss, even those adapted to suit the needs of this particular subgroup, have rarely produced clinically meaningful reductions in weight.

Methods/design

The STRIDE study is a multi-site, parallel, two-arm randomized controlled translational trial. Participants were recruited from community mental health clinics and an integrated not-for-profit health system. Participants were randomized either to usual care or to a 12-month intervention that consisted of: 1) weekly group participation for six months covering topics on nutrition, physical activity and lifestyle changes; 2) monthly group participation for an additional six month maintenance period; and 3) individual monthly contacts from intervention group facilitators during the second six month phase. All participants are assessed at baseline, 6, 12, and 24 months post-enrollment. Process and implementation evaluations are included and the study design includes a cost-utility analysis. Participants include 200 individuals with serious mental illness with an average age of 47.1 years, a mean body-mass index of 38.3 kg/m(2) and taking an average of 3.2 psychiatric medications at baseline. Baseline physiological measures included mean blood pressure (SBP/DBP) measurements of 119.2 (SD = 14.7)/79.4 (SD = 10.1); 35% reported a hypertension diagnosis and 11% took antihypertensive medications. Average lipid levels (mg/dL) were: a) triglycerides 188.0 (SD = 138.6), ranged from 43 to 1145; b) LDL 101.4 (SD = 32.9) and ranged from 17 to 185; c) HDL 45.8 (SD = 12.7) and ranged from 22 to 89; and d) total cholesterol 181.6 (SD = 39.7) and ranged from 50 to 324. Average fasting glucose levels were 108.9 (SD = 32.5) and ranged from 24 to 289. Average fasting insulin levels were 13.0 (SD=11.9) and ranged from 2 to 99.

Discussion

The STRIDE study is based on a modified version of the PREMIER comprehensive lifestyle intervention, DASH diet arm. STRIDE has successfully enrolled 200 individuals with serious mental illness in community-based settings. Baseline characteristics present a population at high risk for obesity-related negative health outcomes and demonstrate the need for evidence-based interventions to reduce these risks.

Trial registration

Clinical Trials.gov NCT00790517.

SUBMITTER: Yarborough BJ

PROVIDER: S-EPMC3907020 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

STRIDE: a randomized trial of a lifestyle intervention to promote weight loss among individuals taking antipsychotic medications.

Yarborough Bobbi Jo H BJ Leo Michael C MC Stumbo Scott S Perrin Nancy A NA Green Carla A CA

BMC psychiatry 20130928

<h4>Background</h4>Individuals diagnosed with serious mental illnesses are at increased risk of obesity- and cardiovascular-related morbidity and early mortality. Lifestyle interventions aimed at weight loss, even those adapted to suit the needs of this particular subgroup, have rarely produced clinically meaningful reductions in weight.<h4>Methods/design</h4>The STRIDE study is a multi-site, parallel, two-arm randomized controlled translational trial. Participants were recruited from community ...[more]

PMID: 24074269

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Project description:ObjectivesThe STRIDE study assessed whether a lifestyle intervention, tailored for individuals with serious mental illnesses, reduced weight and diabetes risk. The authors hypothesized that the STRIDE intervention would be more effective than usual care in reducing weight and improving glucose metabolism.MethodThe study design was a multisite, parallel two-arm randomized controlled trial in community settings and an integrated health plan. Participants who met inclusion criteria were ≥18 years old, were taking antipsychotic agents for ≥30 days, and had a body mass index ≥27. Exclusions were significant cognitive impairment, pregnancy/breastfeeding, recent psychiatric hospitalization, bariatric surgery, cancer, heart attack, or stroke. The intervention emphasized moderate caloric reduction, the DASH (Dietary Approaches to Stop Hypertension) diet, and physical activity. Blinded staff collected data at baseline, 6 months, and 12 months.ResultsParticipants (men, N=56; women, N=144; mean age=47.2 years [SD=10.6]) were randomly assigned to usual care (N=96) or a 6-month weekly group intervention plus six monthly maintenance sessions (N=104). A total of 181 participants (90.5%) completed 6-month assessments, and 170 (85%) completed 12-month assessments, without differential attrition. Participants attended 14.5 of 24 sessions over 6 months. Intent-to-treat analyses revealed that intervention participants lost 4.4 kg more than control participants from baseline to 6 months (95% CI=-6.96 kg to -1.78 kg) and 2.6 kg more than control participants from baseline to 12 months (95% CI=-5.14 kg to -0.07 kg). At 12 months, fasting glucose levels in the control group had increased from 106.0 mg/dL to 109.5 mg/dL and decreased in the intervention group from 106.3 mg/dL to 100.4 mg/dL. No serious adverse events were study-related; medical hospitalizations were reduced in the intervention group (6.7%) compared with the control group (18.8%).ConclusionsIndividuals taking antipsychotic medications can lose weight and improve fasting glucose levels. Increasing reach of the intervention is an important future step.

Project description:ImportanceGenome-wide association studies have identified genetic loci influencing obesity risk in children. However, the importance of these loci in the associations with weight reduction through lifestyle interventions has not been investigated in large intervention trials.ObjectiveTo evaluate the associations between various obesity susceptibility loci and changes in body weight in children during an in-hospital, lifestyle intervention program.Design, setting, and participantsLong-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children (LOGIC), an interventional prospective cohort study, enrolled 1429 children with overweight or obesity to participate in an in-hospital lifestyle intervention program. Genotyping of 56 validated obesity single-nucleotide variants (SNVs) was performed, and the associations between the SNVs and body weight reduction during the intervention were evaluated using linear mixed-effects models for each SNV. The LOGIC study was conducted from January 6, 2006, to October 19, 2013; data analysis was performed from July 15, 2015, to November 6, 2016.ExposuresA 4- to 6-week standardized in-hospital lifestyle intervention program (daily physical activity, calorie-restricted diet, and behavioral therapy).Main outcomes and measuresThe association between 56 obesity-relevant SNVs and changes in body weight and body mass index.ResultsOf 1429 individuals enrolled in the LOGIC Study, 1198 individuals (mean [SD] age, 14.0 [2.2] years; 670 [56%] girls) were genotyped. A mean (SD) decrease was noted in body weight of -8.7 (3.6) kg (95% CI, -15.7 to -1.8 kg), and body mass index (calculated as weight in kilograms divided by height in meters squared) decreased by -3.3 (1.1) (95% CI, -5.4 to -1.1) (both P < .05). Five of 56 obesity SNVs were statistically significantly associated with a reduction of body weight or body mass index (all P < 8.93 × 10-4 corresponding to Bonferroni correction for 56 tests). Compared with homozygous participants without the risk allele, homozygous carriers of the rs7164727 (LOC100287559: 0.42 kg; 95% CI, 0.31-0.53 kg, P = 4.00 × 10-4) and rs12940622 (RPTOR: 0.35 kg; 95% CI, 0.18-0.52 kg; P = 1.86 × 10-5) risk alleles had a lower reduction of body weight, whereas carriers of the rs13201877 (IFNGR1: 0.65 kg; 95% CI, 0.51-0.79 kg; P = 2.39 × 10-5), rs10733682 (LMX1B: 0.45 kg; 95% CI, 0.27-0.63 kg; P = 6.37 × 10-4), and rs2836754 (ETS2: 0.56 kg; 95% CI, 0.38-0.74 kg; P = 1.51 × 10-4) risk alleles were associated with a greater reduction of body weight after adjustment for age and sex.Conclusions and relevanceGenes appear to play a minor role in weight reduction by lifestyle in children with overweight or obesity. The findings suggest that environmental, social, and behavioral factors are more important to consider in obesity treatment strategies.

Project description:IntroductionChildren and adolescents are increasingly prescribed antipsychotic medications off-label in the treatment of behavioural disorders. While antipsychotic medications are effective in managing behavioural issues, they carry a significant risk of adverse events that compromise ongoing physical health. Of particular concern is the negative impact antipsychotic medications have on cardiometabolic health. Interventions that aim to modify lifestyle habits have the potential to alleviate the adverse effects of antipsychotic medication by enhancing weight management, increasing physical activity, promoting better nutritional practices, improving dietary habits and promoting healthier sleep patterns and sleep hygiene. However, a comprehensive review has not been performed to ascertain the effectiveness of lifestyle interventions for children and adolescents who are at increased risk of antipsychotic-induced compromises to their physical health.Methods and analysisThis systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Four databases will be searched without any year constraints to identify randomised controlled trials that are published in the English language and report a lifestyle intervention compared with usual care with any physical health outcome measure. Trial registers and results repositories will be scoured to identify additional studies. Two reviewers will independently conduct screening, data extraction and quality assessment and compare the results. Quantitative data will be synthesised, where appropriate, through a random-effects meta-analysis model. Otherwise, data will be reported in a qualitative (narrative) synthesis. Heterogeneity will be quantified using the I2 statistic. The Cochrane Risk of Bias 2 tool will be used for risk of bias assessment. The Grading of Recommendations, Assessment, Development and Evaluation system will be used to evaluate the cumulative body of evidence.Ethics and disseminationEthics approval is not required. The publication plan will target high-impact, peer-reviewed journals that fall under the scope of Psychiatry and Mental Health.Prospero registration numberCRD42022380277.

Project description:IntroductionIn pregnancy, people with obesity or excess adiposity are prone to excess gestational weight gain (GWG) and have the highest risks for multiple maternal morbidities. Epidemiological studies suggest that the lowest incidence of adverse maternal and infant outcomes occurs with GWG lower than current recommendations (<5 kg) and with gestational weight maintenance, resulting in fat mass loss, in those with obesity. Data from randomised clinical trials are needed to evaluate the efficacy of a fat mass loss intervention on pregnancy outcomes. The objective of this proof-of-principle randomised controlled trial is to test the effect of a gestational fat mass loss intervention in pregnant individuals with obesity on changes in weight, fat mass and cardiometabolic disease risk factors.Methods and analysisIn this two-site randomised parallel group, 100 women (30% black; 30% Hispanic) with pre-existing obesity (31.0≤body mass index≤55.0 kg/m2) are randomised to usual care (Provider Directed Group) or usual care plus a fat mass loss intervention with food provision (Weight Maintenance Group). The primary outcomes of the trial (Healthy Mamas/Mamis Saludables) are weight, fat mass (via three-compartment model) and cardiometabolic disease risk factors (ie, blood pressure, lipids, glucose, insulin) from baseline (~13 weeks gestation) to ~35 weeks gestation and at 2 weeks postpartum. Secondary aims evaluate the safety of the fat mass loss intervention during pregnancy and test the hypotheses that compared with usual care, the intervention will have no significant adverse effect on fetal growth, neonatal size, infant body composition and other adverse events. Mediators (eg, eating, activity) and moderators (eg, parity, obesity grade, race/ethnicity) of intervention effects are also examined. Finally, the study will explore the effect of prenatal fat mass loss on reducing the incidence of adverse obstetrical outcomes, including non-elective caesarean delivery, gestational diabetes, hypertension and pre-eclampsia.Ethics and disseminationThe trial has been approved by the Pennington Biomedical Research Center Institutional Review Board, is monitored by an independent data and safety monitoring board and will be conducted in agreement with the Declaration of Helsinki. All results, positive, negative and inconclusive, will be disseminated at national and/or international scientific meetings and in peer-reviewed scientific journals.Trial registration numberNCT04731688.

Dataset Information

STRIDE: a randomized trial of a lifestyle intervention to promote weight loss among individuals taking antipsychotic medications.

Background

Methods/design

Discussion

Trial registration

Publications

STRIDE: a randomized trial of a lifestyle intervention to promote weight loss among individuals taking antipsychotic medications.

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