NOT_YET_RECRUITING
SMARTer Weight Loss Management
The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and usual care assessment-only (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) March 2024
🗓️ Primary Completion (Estimated) January 2027
✅ Study Completion (Estimated) April 2027
👥 Enrollment (Estimated) 492
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Over 18 years old
    • * BMI of ≥25, weight \<396 lbs
    • * Must own a Smartphone, and be willing to install the SMARTer app
    • * Participants must also plan to reside in the Chicagoland area for the duration of their participation (i.e., 12 months)
    • * Not enrolled in a formal weight loss program

    Exclusion Criteria:

    • * Cerebrovascular accident or myocardial infarction within six months of enrollment
    • * Diabetes treated with insulin
    • * Pregnancy, lactation or intended pregnancy
    • * Active suicidal ideation
    • * Anorexia or bulimia
    • * Requiring an assistive device for mobility
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 8 May 2023
  • First Submitted that Met QC Criteria 8 May 2023
  • First Posted 17 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 February 2024
  • Last Update Posted 28 February 2024
  • Last Verified February 2024