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NCT04784585 · ClinicalTrials.gov registry record · NA
Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment
A NA study of Obesity, sponsored by The Miriam Hospital.
- Active
- Registry status
- NA
- Development phase
- 204
- Enrollment target
- 1
- Study location
NCT04784585 is a NA study of Obesity that is active but no longer recruiting, run by The Miriam Hospital. The registered enrollment target is 204 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04784585, a NA study of Obesity, is active but no longer recruiting, sponsored by The Miriam Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 204 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Self-Efficacy
- BEHAVIORAL Enhanced Education
- BEHAVIORAL Motivation
- BEHAVIORAL Self-Regulation
- BEHAVIORAL Generic Risk Alert (Active Comparator)
Study Locations (1)
Rhode Island
- Weight Control and Diabetes Research Center - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04784585
The ClinicalTrials.gov registry entry for NCT04784585 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (75% lower). The listed sponsor is The Miriam Hospital, which has 136 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 5 interventions - of which Self-Efficacy is the first listed.
NCT04784585 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT04784585 about?
NCT04784585 is a clinical study titled "Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment". 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 empi...
What is the current status of trial NCT04784585?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 204 participants. The study started on 2021-10-26. Estimated completion is 2026-05-31.
What conditions does trial NCT04784585 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT04784585?
The interventions under investigation include: Self-Efficacy (BEHAVIORAL), Enhanced Education (BEHAVIORAL), Motivation (BEHAVIORAL), Self-Regulation (BEHAVIORAL), Generic Risk Alert (Active Comparator) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04784585?
This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04784585 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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