Lifestyle Intervention for Young Adults With Serious Mental Illness

Not Applicable

Completed

Conditions: Overweight
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depressive Disorder
Obesity

Interventions: Behavioral: BEAT
Behavioral: PeerFIT

Registration Number: NCT02815813

Lead Sponsor: Dartmouth-Hitchcock Medical Center

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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BEAT	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.
PeerFIT	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.

Primary Outcome Measures

Name	Time	Method
Weight	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2): Greater Nashua Mental Health Center
🇺🇸
Nashua, New Hampshire, United States
Community Mental Health Affiliates
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New Britain, Connecticut, United States