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
2 other identifiers
interventional
150
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Jul 2017
Longer than P75 for not_applicable schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedStudy Start
First participant enrolled
July 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedResults Posted
Study results publicly available
January 14, 2025
CompletedJanuary 14, 2025
November 1, 2024
4.9 years
June 24, 2016
August 6, 2024
January 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight
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
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 Outcomes (3)
Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale
Six months and 12 months
Social Provisions Scale (SPS)
Six months and 12 months
Hemoglobin A1C
Baseline, 6 months, and 12 months
Study Arms (2)
PeerFIT
EXPERIMENTALPeerFIT 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.
BEAT
ACTIVE COMPARATORBEAT 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- % 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Community Mental Health Affiliates
New Britain, Connecticut, 06052, United States
Greater Nashua Mental Health Center
Nashua, New Hampshire, 03060, United States
Related Publications (2)
Aschbrenner KA, Naslund JA, Gorin AA, Mueser KT, Browne J, Wolfe RS, Xie H, Bartels SJ. Group Lifestyle Intervention With Mobile Health for Young Adults With Serious Mental Illness: A Randomized Controlled Trial. Psychiatr Serv. 2022 Feb 1;73(2):141-148. doi: 10.1176/appi.ps.202100047. Epub 2021 Jun 30.
PMID: 34189933DERIVEDAschbrenner KA, Naslund JA, Gorin AA, Mueser KT, Scherer EA, Viron M, Kinney A, Bartels SJ. Peer support and mobile health technology targeting obesity-related cardiovascular risk in young adults with serious mental illness: Protocol for a randomized controlled trial. Contemp Clin Trials. 2018 Nov;74:97-106. doi: 10.1016/j.cct.2018.10.005. Epub 2018 Oct 11.
PMID: 30316998DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kelly Aschbrenner
- Organization
- Dartmouth-Hitchcock
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly A Aschbrenner, PhD
Dartmouth-Hitchcock and Geisel School of Medicine at Dartmouth College
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
June 24, 2016
First Posted
June 28, 2016
Study Start
July 3, 2017
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
January 14, 2025
Results First Posted
January 14, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
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.