Clinical trial NCT02815813: 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
Overall status: COMPLETED
Phase: NA
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
Smartphone
Mobile Technology
mHealth
Social Media
Facebook
Lifestyle Intervention
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Weight
timeFrame: Baseline, 6 months, and 12 months
measure: 6-minute Walk Test
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: Self-efficacy for Exercise Behaviors Assessed Using the Self-efficacy for Exercise Behaviors (SEB) Scale
timeFrame: Six months and 12 months
measure: Social Provisions Scale (SPS)
timeFrame: Six months and 12 months
measure: Hemoglobin A1C
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
Locations:
city: New Britain
country: United States
facility: Community Mental Health Affiliates
state: Connecticut
city: Nashua
country: United States
facility: Greater Nashua Mental Health Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock and Geisel School of Medicine at Dartmouth College
name: Kelly A Aschbrenner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.