Lifestyle Intervention for Young Adults With Serious Mental Illness
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depressive Disorder; Overweight; Obesity
MeSH terms: Overweight; Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

Intervention name(s): PeerFIT; BEAT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
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