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Lifestyle Intervention for Young Adults With Serious Mental Illness | Clinical Trials | Clareo Health

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Lifestyle Intervention for Young Adults With Serious Mental Illness

Peer Support and Mobile Technology Targeting Cardiometabolic Risk Reduction in Young Adults With Serious Mental Illness

NCT02815813•Dartmouth-Hitchcock Medical Center

Summary

This is a four year project evaluating the effectiveness of a group-based lifestyle intervention (PeerFIT) supported by mobile health (mHealth) technology and social media compared to 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 in young adults with serious mental illness (SMI).

Detailed Description

The objective of this study is to evaluate the effectiveness of a group-based lifestyle intervention (PeerFIT) supported by mobile health (mHealth) technology and social media to promote weight loss and improved fitness in young adults with serious mental illness (SMI). The study is a two-arm randomized controlled trial conducted in real world mental health settings to evaluate the effectiveness of the 12-month PeerFIT intervention compared to 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. The investigators will enroll 144 overweight and obese (BMI ≥ 25) young adults ages 18 to 35 with SMI attending one of two community mental health who are interested in losing weight and improving fitness. The investigators hypothesize that PeerFIT compared to BEAT will be associated with a greater proportion of participants who achieve cardiovascular risk reduction at 6 and 12 months follow-up as indicated by either clinically significant weight loss (5% or greater) or increased fitness (\>50 m on the six-minute walk test). The investigators also hypothesize that PeerFIT compared to BEAT will be associated with greater improvements in A1c and lipid profiles at 6 and 12 months follow-up. They will also investigate two theoretical mechanisms of action hypothesized to account for greater weight loss and increased cardiorespiratory fitness among participants assigned to PeerFIT: 1) improved self-efficacy and 2) increased peer support for health behavior change. The investigators hypothesize that the relationship between PeerFIT and weight loss and improved fitness will be mediated by improved self-efficacy and peer support for health behavior change.

Eligibility

Age

18 - 35 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Young adults ages 18 to 35
•Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression
•Overweight or obese defined as BMI ≥25
•Enrolled in treatment at the agency for at least 3 months prior to study recruitment
•Have not started taking Clozapine or Olanzapine antipsychotic medications over the prior 2 months (dose changes are allowed)
•Able and willing to give written informed consent to participate in the study or able to assent with guardian consent
•Willingness to be randomized to either of the two conditions
•Able and willing to attend the weekly 60-minute weight management session, participate in the weekly 1-hour physical activity sessions, and use the Facebook and mHealth (i.e., Fitbits and text messaging) components of the PeerFIT program

Exclusion Criteria

•Medical contraindication to weight loss (e.g., cancer, stroke, liver failure)
•Medical conditions (e.g., diabetes, angina) that do not receive medical clearance by a primary care provider
•Major surgery planned or likely to occur within the next 6 months
•Prior or planned bariatric surgery
•Use of prescription weight loss medication within the past 6 months
•5% or greater weight loss in 3 months prior to baseline
•Currently enrolled in another weight reduction program
•Pregnant or planning a pregnancy, or breastfeeding during study period
•Cognitive impairment sufficient to interfere with participant's ability to provide informed consent, complete study questionnaires, or participate in a group intervention as indicated by a Mini Mental Status Examination score \<24
•Active substance use determined to be incompatible with participation in the intervention identified by screening questionnaire that assesses for excessive use according to intake limits by gender
+3 more criteria

Locations (2)

Community Mental Health Affiliates

New Britain, Connecticut, United States

Greater Nashua Mental Health Center

Nashua, New Hampshire, United States

Key Dates

Start Date

July 3, 2017

Primary Completion Date

May 31, 2022

Completion Date

May 31, 2022

Last Updated

January 14, 2025

Enrollment

150

ACTUAL participants

Conditions

SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderOverweightObesity

Interventions

PeerFIT

BEHAVIORAL

BEAT

BEHAVIORAL

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Lifestyle Intervention for Young Adults With Serious Mental Illness

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques