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Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 22, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Trial arms changed: 6 → 1
    • Interventions: Enhanced Education (Behavioral), Generic Risk Alert (Active Comparator) (Behavioral), Motivation (Behavioral), Online Behavioral Obesity… to JITAI Enhanced Education Intervention Option (Behavioral), JITAI Generic Risk Alert Intervention Option (Active Comparator) (Behavioral)…
    v10
  2. Notable Primary and study completion dates: Oct 30, 2024 to May 31, 2026
    • Trial status: Completed to Active, Not Recruiting
    v9
  3. Minor Re-verified, no change to tracked fieldsv8
  4. Minor Trial status: Recruiting to Completedv7 Show 4 more changesShow less
    • Enrollment target: estimated 159 to confirmed 204
    • Primary completion date: Oct 31, 2024 to Oct 30, 2024
    • Study completion date changed from estimate of May 31, 2025 to Oct 30, 2024
    • Site details revised
  5. Minor Site contact updatedv6
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  1. Notable Primary completion date: Mar 31, 2024 to Oct 31, 2024
    • Study completion date: May 31, 2024 to May 31, 2025
    v5
  2. Minor Primary completion date: Nov 30, 2023 to Mar 31, 2024v4
  3. Notable Start date changed from estimate of Apr 1, 2021 to Oct 26, 2021v3
  4. Minor Start date: Mar 15, 2021 to Apr 1, 2021v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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This project targets dietary lapses (instances of nonadherence to dietary goals), a major cause of poor outcomes during behavioral obesity treatment, which is a recommended first-line intervention for cardiovascular disease. The investigators propose to conduct a micro-randomized trial (MRT) to empirically optimize a smartphone-based just-in-time adaptive intervention (JITAI) that monitors risk and intervenes on lapses as needed. By evaluating the immediate, proximal effect of four theory-driven interventions on lapse behavior, the project will: (a) produce a scalable, finalized JITAI that has the greatest potential to show clear clinical impact in future trials; and (b) inform the development of more sophisticated theoretical models of adherence behavior more broadly. Therefore, this study has three goals. First the investigators aim to compare the effects of delivering any intervention to no intervention on the occurrence of lapse. Second, the investigators aim to compare the effects of specific theory-driven interventions to one another to determine which ones are best for preventing lapses. Within this second aim, the investigators also aim to examine other factors that may influence the effectiveness of interventions (e.g., time, location). Lastly, the investigators will use the data from this MRT to customize intervention delivery in future versions of this JITAI Patients will be recruited through various methods including advertisements in local media, targeted online advertising, advertisements in medical and minority communities, and direct mailers. All participants will receive a well-established 3-month online obesity treatment program, with 3 months of no-treatment follow-up. In conjunction, they will use a smartphone-based JITAI consisting of: 1) repeated daily surveys assess lapses and relevant triggers; 2) a machine learning algorithm that uses information from the surveys to determine real-time lapse risk; \& 3) interventions to counter lapse risk. When an individual is at risk for lapsing she will be randomly assigned to no intervention, a generic risk alert, or one of 4 theory-driven interventions with interactive skills training. The outcome of interest will be the occurrence (or lack thereof) of dietary lapse, as measured both subjectively (i.e., reported by the participant in the daily surveys) and objectively (i.e., via wrist-based intake monitoring), in the hours following randomization initiated by heightened lapse risk.
Trial Details
NCT Number NCT04784585
Lead Sponsor The Miriam Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Obesity
Related terms Obesity
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov