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Lifestyle Intervention for Young Adults With Serious Mental Illness

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ClinicalTrials.gov Identifier: NCT02815813
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kelly Aschbrenner, PhD, 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).

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder Overweight Obesity Behavioral: PeerFIT Behavioral: BEAT Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peer Support and Mobile Technology Targeting Cardiometabolic Risk Reduction in Young Adults With Serious Mental Illness
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: PeerFIT
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.

Active Comparator: 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.
Behavioral: BEAT
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 Measures :
  1. Change in 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.

  2. Change in 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.


Secondary Outcome Measures :
  1. Change in weight loss self-efficacy assessed using the Weight Efficacy Lifestyle (WEL) questionnaire [ Time Frame: Baseline, 6 months, and 12 months ]
    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.

  2. Change in self-efficacy for exercise behaviors assessed using the Self-efficacy for Exercise Behaviors (SEB) scale [ Time Frame: Baseline, 6 months, and 12 months ]
    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.

  3. Change in peer support for health behavior change assessed using the 24-item Social Provisions Scale (SPS) [ Time Frame: Baseline, 6 months, and 12 months ]
    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.

  4. Change in serum lipids [ Time Frame: Baseline, 6 months, and 12 months ]
    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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815813


Contacts
Contact: Kelly A Aschbrenner, PhD 603-359-0921 kelly.aschbrenner@dartmouth.edu

Locations
United States, Massachusetts
Vinfen Recruiting
Cambridge, Massachusetts, United States, 02141
Contact: Stacy McHugh    978-587-6863    mchughs@vinfen.org   
United States, New Hampshire
The Mental Health Center of Greater New Hampshire Recruiting
Manchester, New Hampshire, United States, 03101
Contact: Harry Cunningham    603-782-0674    cunningh@mhcgm.org   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Kelly A Aschbrenner, PhD Dartmouth-Hitchcock and Geisel School of Medicine at Dartmouth College

Responsible Party: Kelly Aschbrenner, PhD, Scientist, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02815813     History of Changes
Other Study ID Numbers: STUDY00029586
R01MH110965 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly Aschbrenner, PhD, Dartmouth-Hitchcock Medical Center:
Serious Mental Illness
Young Adults
Obesity
Cardiometabolic Risk
Physical Activity
Weight Loss
Fitness
Peer Support
Smartphone
Mobile Technology
mHealth
Social Media
Facebook
Lifestyle Intervention

Additional relevant MeSH terms:
Disease
Schizophrenia
Depressive Disorder
Depression
Overweight
Depressive Disorder, Major
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Behavioral Symptoms
Body Weight
Signs and Symptoms
Bipolar and Related Disorders