Lifestyle Intervention for Young Adults With Serious Mental Illness

January 10, 2025 updated by: Kelly Aschbrenner, PhD, Dartmouth-Hitchcock Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Britain, Connecticut, United States, 06052
        • Community Mental Health Affiliates
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Greater Nashua Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

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
  • Use of anabolic steroids with the drug taken at least "most days of the week for the previous month"
  • Planning to leave agency or move out of geographic area within 12 months
  • People who are non-English speakers or who have major visual or hearing impairment will be excluded given the need to read the program materials and interact with technology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PeerFIT
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.
Behavioral: PeerFIT
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.
Behavioral: BEAT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months, and 12 months
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.
Baseline, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale
Time Frame: Six months and 12 months

The Self-efficacy for Exercise Behaviors (SEB) scale was used to measure participants' self-efficacy related to the ability to exercise despite common barriers. Five items represent the following areas:

negative affect, resisting relapse, and making time for exercise. Respondents rate their confidence on a five-point Likert scale from 1 = "I know I cannot" to 4 = "I know I can". Total scores range from 5 to 20. Higher overall scores indicate higher exercise self efficacy.
Six months and 12 months
Social Provisions Scale (SPS)
Time Frame: Six months and 12 months
Participants' level of perceived peer support was measured with the Social Provisions Scale (SPS). The SPS consists of 10 questions items assessing an individual's perceived social support across different dimensions like attachment, guidance, social integration, reliable alliance, and reassurance of worth; essentially assessing how much support they feel they receive from their social network. The items are rated on a 4-point Likert scale from 1 ("strongly disagree) to 4 ("strongly agree") as it pertains to relationships with group members. Scores range from 10 to 40. Higher scores indicate greater perceived support from group relationships.
Six months and 12 months
Hemoglobin A1C
Time Frame: Baseline, 6 months, and 12 months
Hemoglobin A1C will be measured using the CardioChek PA Analyzer.
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Kelly A Aschbrenner, PhD, Dartmouth-Hitchcock and Geisel School of Medicine at Dartmouth College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2017

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimated)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00029586
  • R01MH110965 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The proposed project involves human subject data, and all data collected on subjects (both positive and negative) will be submitted to the National Database for Clinical Trials Related to Mental Illness (NDCT). This will include individual level data from all subjects enrolled in both the active intervention and control conditions.

The NDCT is a secure data repository run by the National Institute of Mental Health (NIMH) that allows researchers to collect and share de-identified information with each other. This secure informatics platform facilitates scientific collaboration and data sharing, and enables effective communication of detailed research data, tools, and supporting documentation. The NDCT links data across research projects using Global Unique Identifiers (GUID) for each participant, and the NDCT Data Dictionary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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