Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness
This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR\&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools. Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The Investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight
Conditions:
🦠 Serious Mental Illness
🗓️ Study Start (Actual) 2 August 2021
🗓️ Primary Completion (Estimated) 30 September 2025
✅ Study Completion (Estimated) 30 September 2025
👥 Enrollment (Estimated) 260
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depressive disorder with psychosis;
    • * age 18 and over;
    • * BMI \>= 30.0 (obese); and
    • * ownership of a phone running Android OS or iOS (iPhone).

    Exclusion Criteria:

    • * chart diagnosis of dementia;
    • * history of bariatric surgery;
    • * pregnant and nursing mothers;
    • * patient has a conservator/legally authorized representative who makes their medical decisions;
    • * psychiatric hospitalization during the month prior to enrollment.
    • Additionally, we will follow the American College of Sports Medicine recommendations for health screening and risk stratification in preparation for starting a moderate intensity exercise program to ensure that participants enrolled are capable of safely engaging in the app's recommendations regarding physical activity. Specifically, all potential participants will be given the Physical Activity Readiness Questionnaire (PAR-Q), a screening tool often used in weight management trials. If they endorse symptoms or major signs suggestive of cardiopulmonary disease (i.e., angina, anginal equivalent, dyspnea, syncope, orthopnea, edema, palpitations or claudication), which is a score \>=1 on the PAR-Q, they will need clearance from a VA physician before enrolling.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 September 2020
  • First Submitted that Met QC Criteria 16 September 2020
  • First Posted 23 September 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 June 2024
  • Last Update Posted 7 June 2024
  • Last Verified June 2024