N/A
N=150
Lifestyle Intervention for Young Adults With Serious Mental Illness
Schizophrenia · Schizoaffective Disorder · Bipolar Disorder · Major Depressive Disorder · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT02815813 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Weight — 107.6; 105.1; 109.7; 106.7 Kilogram — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PeerFIT (Behavioral); BEAT (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
107.6; 105.1; 109.7; 106.7; 109.2; 106.9 | <0.01 sig |
| PRIMARY 6-minute Walk Test |
1398; 1424; 1386; 1426; 1357; 1319 | <0.01 sig |
| SECONDARY Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale |
11; 10.7; 11.2; 10.2 | — |
| SECONDARY Social Provisions Scale (SPS) |
29.2; 27.1 | — |
| SECONDARY Hemoglobin A1C |
5.3; 5.3; 5.3; 5.3; 5.6; 5.5 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02815813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.