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Lifestyle Intervention for Young Adults With Serious Mental Illness

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PeerFIT

BEAT

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Serious Mental Illness, Young Adults, Obesity, Cardiometabolic Risk, Physical Activity, Weight Loss, Fitness, Peer Support, Smartphone, Mobile Technology, mHealth, Social Media, Facebook, Lifestyle Intervention

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Community Mental Health Affiliates
Greater Nashua Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PeerFIT

BEAT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in 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.

Change in 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.

Secondary Outcome Measures

Change in weight loss self-efficacy assessed using the Weight Efficacy Lifestyle (WEL) questionnaire

The Weight Efficacy Lifestyle (WEL) questionnaire will be used to measure self-efficacy for weight loss. The WEL consists of 20 items designed to measure self-confidence to control weight by resisting overeating in certain tempting situations. The total score will be used in analyses. The items are scored on a 10-point Likert scale from 0 ("not confident") to 10 ("very confident") and total score calculated as the sum of individual item responses.

Change in self-efficacy for exercise behaviors assessed using the Self-efficacy for Exercise Behaviors (SEB) scale

The Self-efficacy for Exercise Behaviors (SEB) scale will be used to measure participants' self-efficacy related to the ability to exercise despite barriers. The 12-item scale consists of common barriers that might affect participation in exercise (e.g., feeling depressed, socializing, stressful life changes, household chores). For each situation, participants use the scale from 1 ("I know I cannot") to 5 ("I know I can") to describe his or her confidence that they could exercise in the face of these barriers.

Change in peer support for health behavior change assessed using the 24-item Social Provisions Scale (SPS)

Participants' level of perceived peer support will be measured with the 24-item Social Provisions Scale (SPS). The SPS assesses six types of support from social relationships (guidance, reliable alliance, reassurance of worth, attachment, social integration, and opportunity for nurturance) and the total score will be used in the analysis. The items are scored on a 4-point Likert scale from 1 ("strongly disagree) to 4 ("strongly agree") as it pertains to relationships with group members. Higher scores indicate greater perceived support from group relationships.

Change in serum lipids

Lipids will be measured using the CardioChek PA Analyzer, a hand-held dual testing system that produces values for total cholesterol, LDL, HDL, and triglycerides using a multi-panel test strip and a single drop of blood acquired with a finger prick.

Full Information

NCT ID

NCT02815813

First Posted

June 24, 2016

Last Updated

October 13, 2022

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT02815813

Brief Title

Lifestyle Intervention for Young Adults With Serious Mental Illness

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

July 3, 2017 (Actual)

Primary Completion Date

May 31, 2022 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, Smartphone, Mobile Technology, mHealth, Social Media, Facebook, Lifestyle Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PeerFIT

Arm Type

Experimental

Arm Description

Arm Title

BEAT

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PeerFIT

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

BEAT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in weight

Description

Time Frame