NCT02815813.

Study name	Lifestyle Intervention for Young Adults With Serious Mental Illness
Methods	Randomised controlled trial
Participants	Overweight and obese (BMI ≥ 25) young adults ages 18 to 35 with SMI, attending 1 of 2 community mental health centres who are interested in losing weight and improving fitness
Interventions	A 12‐month PeerFIT intervention vs basic education in fitness and nutrition supported by a wearable activity tracking device (BEAT) in achieving clinically significant improvements in weight loss and cardiorespiratory fitness
Outcomes	Primary outcomes: 1. Change in weight (time frame: baseline, 6 months, and 12 months). Participants' weight will be measured in pounds (lbs) on a flat, even surface with the use of a high‐quality, calibrated professional medical scale, with the participant wearing indoor clothing and no shoes 2. Change in 6‐minute walk test (time frame: baseline, 6 months, and 12 months). After a baseline blood pressure has been obtained, participants are asked to walk a measured distance as far as they are able in 6 minutes Secondary outcomes: 1. Change in weight loss self‐efficacy assessed by the Weight Efficacy Lifestyle (WEL) questionnaire (time frame: baseline, 6 months, and 12 months). The Weight Efficacy Lifestyle (WEL) questionnaire will be used to measure self‐efficacy for weight loss. The WEL consists of 20 items designed to measure self‐confidence to control weight by resisting overeating in certain tempting situations. The total score will be used in analyses. Items are scored on a 10‐point Likert scale from 0 ("not confident") to 10 ("very confident") and total score calculated as the sum of individual item responses 2. Change in self‐efficacy for exercise behaviours assessed by the Self‐efficacy for Exercise Behaviors (SEB) scale (time frame: baseline, 6 months, and 12 months). The SEB scale will be used to measure participants' self‐efficacy related to the ability to exercise despite barriers. The 12‐item scale consists of common barriers that might affect participation in exercise (e.g. feeling depressed, socialising, stressful life changes, household chores). For each situation, participants use the scale from 1 ("I know I cannot") to 5 ("I know I can") to describe their confidence that they could exercise in the face of these barriers 3. Change in peer support for health behaviour change assessed by the 24‐item Social Provisions Scale (SPS) (time frame: baseline, 6 months, and 12 months). Participants' level of perceived peer support will be measured by the 24‐item SPS. The SPS assesses 6 types of support from social relationships (guidance, reliable alliance, reassurance of worth, attachment, social integration, and opportunity for nurturance), and the total score will be used in the analysis. Items are scored on a 4‐point Likert scale from 1 ("strongly disagree) to 4 ("strongly agree") as it pertains to relationships with group members. Higher scores indicate greater perceived support from group relationships 4. Change in serum lipids (time frame: baseline, 6 months, and 12 months). Lipids will be measured by the CardioChek PA Analyzer, a hand‐held dual testing system that produces values for total cholesterol, LDL, HDL, and triglycerides via a multi‐panel test strip and a single drop of blood acquired with a finger prick
Starting date	July 2017
Contact information	Principal Investigator: Kelly A Aschbrenner, PhD Dartmouth‐Hitchcock and Geisel School of Medicine at Dartmouth College
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