SchizophreniaNCT02815813

Lifestyle Intervention for Young Adults With Serious Mental Illness

A study testing PeerFIT and BEAT in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
What is being tested?: PeerFIT and BEAT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 2 sitesUnited States
Study dates: 3 Jul 2017to 31 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Overweight, Obesity
Being tested: PeerFIT, BEAT
Keywords: Serious Mental Illness, Young Adults, Obesity, Cardiometabolic Risk, Physical Activity, Weight Loss, Fitness, Peer Support, Smartphone, Mobile Technology, mHealth, Social Media, Facebook, Lifestyle Intervention
Medical subject headings: Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major, Overweight, Obesity, Motor Activity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PeerFITBehavioural
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.
BEATBehavioural
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.

Study groups in NCT02815813
Study group	Role	What they receive
PeerFIT	Experimental	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. Receives: Behavioral: PeerFIT
BEAT	Active comparator	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. Receives: Behavioral: BEAT

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline, 6 months, and 12 months

Secondary outcomes (3)

Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale
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.
Measured: Six months and 12 months
Social Provisions Scale (SPS)
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.
Measured: Six months and 12 months
Hemoglobin A1C
Hemoglobin A1C will be measured using the CardioChek PA Analyzer.
Measured: Baseline, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201731 May 2022

First posted28 Jun 2016 (estimated)
Study start3 Jul 2017
Primary completion31 May 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02815813
Sponsor's protocol ID: STUDY00029586
Other IDs: R01MH110965
Status last verified: Nov 2024
First submitted: 24 Jun 2016
Last updated: 14 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 34189933
Aschbrenner 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.
PubMed 30316998

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peer Support and Mobile Technology Targeting Cardiometabolic Risk Reduction in Young Adults With Serious Mental Illness
ClinicalTrials.gov ID: NCT02815813
Acronym / sponsor ID: STUDY00029586
Conditions: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Overweight, Obesity
Keywords: Serious Mental Illness, Young Adults, Obesity, Cardiometabolic Risk, Physical Activity, Weight Loss, Fitness, Peer Support
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 3 Jul 2017 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 28 Jun 2016 (estimated)
Results: Posted 14 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PeerFIT	Experimental	Behavioral: PeerFITPeerFIT 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 comparator	Behavioral: BEATBEAT 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.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PeerFITThe 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.	Behavioural	PeerFIT
BEATParticipants 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.	Behavioural	BEAT

Primary outcome

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.
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.

3 secondary outcomes

Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale
Time frame: Six months and 12 months
Social Provisions Scale (SPS)
Time frame: Six months and 12 months
Hemoglobin A1C
Time frame: Baseline, 6 months, and 12 months

Results and safety

Results posted to the registry on 14 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PeerFIT	76	53
BEAT	74	51

Primary outcome: Weight

Time frame: Baseline, 6 months, and 12 months. Mean (Standard Deviation). Unit: Kilogram

Measure	PeerFIT n = 76	BEAT n = 74
Baseline weight	107.6 (26.9)	105.1 (20.9)
6-month weight	109.7 (26.3)	106.7 (22.1)
12-month weight	109.2 (27.6)	106.9 (22.5)

PeerFIT vs BEAT: p <0.01, GLMM

Population analysed: Participants at baseline, 6 months and 12 months

Primary outcome: 6-minute Walk Test

Time frame: Baseline, 6 months, and 12 months. Mean (Standard Deviation). Unit: feet

Measure	PeerFIT n = 76	BEAT n = 74
Baseline	1398 (296)	1424 (250)
6-months	1386 (296)	1426 (248)
12-months	1357 (271)	1319 (332)

PeerFIT vs BEAT: p <0.01, GLMM

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PeerFIT	0 of 76 (0%)	0 of 76 (0%)	0 of 76
BEAT	0 of 74 (0%)	0 of 74 (0%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34189933Aschbrenner 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.
Derived from this study: PubMed 30316998Aschbrenner 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kelly A Aschbrenner, PhD principal investigator

Dartmouth-Hitchcock and Geisel School of Medicine at Dartmouth College

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PeerFIT and BEAT in people with Schizophrenia and Schizoaffective Disorder, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: Baseline, 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02815813, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.