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The STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic medications: a randomized trial.

ABSTRACT: The 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.The 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.Participants (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%).Individuals taking antipsychotic medications can lose weight and improve fasting glucose levels. Increasing reach of the intervention is an important future step.

SUBMITTER: Green CA

PROVIDER: S-EPMC4282602 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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The STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic medications: a randomized trial.

Green Carla A CA Yarborough Bobbi Jo H BJ Leo Michael C MC Yarborough Micah T MT Stumbo Scott P SP Janoff Shannon L SL Perrin Nancy A NA Nichols Greg A GA Stevens Victor J VJ

The American journal of psychiatry 20141031 1

<h4>Objectives</h4>The 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.<h4>Method</h4>The study design was a multisite, parallel two-arm randomized controlled trial in community settings and an integrated health plan. Participants who met inclusion criteri ...[more]

PMID: 25219423

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Project description:BackgroundIndividuals 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/designThe 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.DiscussionThe 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 registrationClinical Trials.gov NCT00790517.

Project description:BackgroundDNA methylation age (mAge), a methylation biomarker for the aging process, might serve as a more accurate predictor of morbidity and aging status than chronological age. We evaluated the role of multiple factors, including fat deposition, cardiometabolic risk factors and lifestyle weight-loss intervention, on the deviation of mAge from chronological age (mAge deviation) or 18-month change in mAge (?mAge). In this sub-study of the CENTRAL magnetic resonance imaging weight-loss trial, we evaluated mAge by a validated 240-CpG-based prediction formula at baseline and after 18-month intervention of either low fat (LF) or mediterranean/low carbohydrate (MED/LC) diets.ResultsAmong 120 CENTRAL participants with abdominal obesity or dyslipidemia, mAge (mean?±?SD: 60.3?±?7.5 years) was higher than the chronological age (48.6?±?9.3 years) but strongly correlated (r?=?0.93; p?=?3.1?×?10-53). Participants in the lowest tertile of mAge deviation from their chronological age had significantly lower waist-circumference, visceral adipose tissue, intrahepatic fat (IHF) content, fasting-glucose and HOMA-IR, as compared with participants in the highest sex-specific residual tertile (p?<?0.05 for all). IHF% remained associated with greater mAge deviation after further adjustments (??=?0.23; p?=?0.02). After 18-month weight-loss lifestyle intervention, mAge remained significantly correlated with chronological age (r?=?0.94, p?=?1.5?×?10-55). mAging occurred, with no difference between lifestyle intervention groups (??=?0.9?±?1.9 years in MED/LC vs. ??=?1.3?±?1.9 years in LF; p?=?0.2); however, we observed a mAging attenuation in successful weight losers (>?5% weight loss) vs. weight-loss failures ( ??=?0.6 years vs. ??=?1.1 years; p?=?0.04), and in participants who completed the trial with healthy liver fat content (<?5% IHF) vs. participants with fatty liver (??=?0.6 years vs. ??=?1.8 years; p?=?0.003). Overall, 18 months of weight-loss lifestyle intervention attenuated the mAging of the men, mainly the older, by 7.1 months than the expected (p?<?0.05).ConclusionsLifestyle weight-loss intervention may attenuate mAging. Deviation of mAge from chronological age might be related to body fat distribution and glycemic control and could indicate biological age, health status and the risk for premature cardiometabolic diseases.Trial registrationClinicalTrials.gov NCT01530724. Registered 10 February 2012, https://clinicaltrials.gov/ct2/show/study/NCT01530724 .

Project description:The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months.At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level.Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.clinicaltrials.gov Identifier: NCT00842426.

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The STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic medications: a randomized trial.

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The STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic medications: a randomized trial.

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