Lifestyle Intervention for Young Adults With Serious Mental Illness
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|ClinicalTrials.gov Identifier: NCT02815813|
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder Overweight Obesity||Behavioral: PeerFIT Behavioral: BEAT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Peer Support and Mobile Technology Targeting Cardiometabolic Risk Reduction in Young Adults With Serious Mental Illness|
|Actual Study Start Date :||July 3, 2017|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||June 30, 2020|
PeerFIT is a group-based lifestyle intervention enhanced by mobile health technology and social media designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
Active Comparator: BEAT
BEAT involves basic education in fitness and nutrition supported by a wearable activity tracking device designed to achieve clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness.
Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
- 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.
- 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.
- Change in weight loss self-efficacy assessed using 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. The 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.
- Change in self-efficacy for exercise behaviors assessed using the Self-efficacy for Exercise Behaviors (SEB) scale [ Time Frame: Baseline, 6 months, and 12 months ]The Self-efficacy for Exercise Behaviors (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, socializing, 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 his or her confidence that they could exercise in the face of these barriers.
- Change in peer support for health behavior change assessed using the 24-item Social Provisions Scale (SPS) [ Time Frame: Baseline, 6 months, and 12 months ]Participants' level of perceived peer support will be measured with the 24-item Social Provisions Scale (SPS). The SPS assesses six 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. The 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.
- Change in serum lipids [ Time Frame: Baseline, 6 months, and 12 months ]Lipids will be measured using the CardioChek PA Analyzer, a hand-held dual testing system that produces values for total cholesterol, LDL, HDL, and triglycerides using a multi-panel test strip and a single drop of blood acquired with a finger prick.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815813
|Contact: Kelly A Aschbrenner, PhDemail@example.com|
|United States, Connecticut|
|Community Mental Health Affiliates||Recruiting|
|New Britain, Connecticut, United States, 06052|
|Contact: Heather Paluso 860-826-1358 ext 1671 HPaluso@CMHACC.org|
|United States, Massachusetts|
|Vinfen||Active, not recruiting|
|Cambridge, Massachusetts, United States, 02141|
|United States, New Hampshire|
|The Mental Health Center of Greater New Hampshire||Active, not recruiting|
|Manchester, New Hampshire, United States, 03101|
|Greater Nashua Mental Health Center||Recruiting|
|Nashua, New Hampshire, United States, 03060|
|Contact: Susan Flynn 603-402-1538 firstname.lastname@example.org|
|Principal Investigator:||Kelly A Aschbrenner, PhD||Dartmouth-Hitchcock and Geisel School of Medicine at Dartmouth College|