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SMARTer Weight Loss Management

Study acronym: SMARTer
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: Northwestern University to Florida State Universityv8 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Primary completion date: Jul 1, 2027 to Apr 30, 2027
    • Study completion date: Jan 1, 2028 to Oct 31, 2027
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study site revised
    • Collaborators shortened, about 3 words
  2. Eligibility criteria shortened, about 19 words
    • Collaborators expanded, about 3 words
    v7
  3. Interventions: Adaptive SMARTer intervention (SMARTer) (Behavioral), Diabetes Prevention Program Participants (DPP) (Behavioral) to Adaptive SMARTer intervention (SMARTer) (Behavioral), Diabetes Prevention Program (DPP) (Behavioral), Self-Guided Treatment (Self-Guided)…v6
  4. Primary completion date: Jan 2027 to Jul 1, 2027
    • Study completion date: Apr 2027 to Jan 1, 2028
    v5
  5. Eligibility criteria expanded, about 8 wordsv4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2024 to Jun 25, 2024
    • Site details revised
    v3
  2. Start date: Jan 2024 to Mar 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and Self-Guided (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.
Trial Details
NCT Number NCT05861973
Lead Sponsor Florida State University
Conditions
(from sponsor)		 Obesity
Related terms Obesity
Enrollment 492 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov