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NCT04337619 · ClinicalTrials.gov registry record · NA
Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
A NA study of Obesity and Weight Loss, sponsored by Drexel University.
- Completed
- Registry status
- NA
- Development phase
- 276
- Enrollment target
- 1
- Study location
NCT04337619: Completed NA study of Obesity and Weight Loss, sponsored by Drexel University.
NCT04337619 is a NA study of Obesity and Weight Loss that has completed, run by Drexel University. The registered enrollment target is 276 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04337619, a NA study of Obesity and Weight Loss, has completed, sponsored by Drexel University.
- COMPLETED
- Registry status
- NA
- Development phase
- 276 participants
- Enrollment target
- 1
- Study location
Study Summary
Mindfulness and Acceptance based Behavioral Therapies (MABTs) are among the most promising behavioral approaches for obesity, with two recent large trials showing that they achieve better initial weight loss and/or better weight loss maintenance than does gold standard behavioral weight loss treatment (BT). However, results vary, potentially due to inconsistencies in how MABT components are utilized and emphasized. Optimizing MABTs using a typical approach, i.e., successive randomized controlled trials of various MABT packages, is slow and difficult. Multiphase Optimization Strategy (MOST) has been developed as a better method of optimizing treatment. Consistent with Phase I of MOST, we derived three MABT components from the theoretical literature. Evaluation of MABT components through a factorial design (MOST Phase II) will allow us to determine the independent and interacting efficacies of each MABT component, in addition to the identification of subsets of individuals most or least responsive to each component. Whereas mediational analyses have been inconclusive, the use of a factorial design will allow for a critical test of the main and interaction effects of individual MABT treatment components. The current study will use a full factorial design to identify the independent and combined effects of three core MABT components (Awareness, Acceptance, and Values Clarity) as additions to remotely delivered weight loss counseling. Moderators of treatment outcome (disinhibited eating, food cue susceptibility, emotional eating, delay discounting, and inhibitory control), and mediator/process variables implicated in MABTs (mindful eating, acceptance of food cues, mindfulness, body responsiveness, autonomous motivation, values clarity, hunger/satiety perceptions, and motivation and pleasure resulting from social functioning) will be assessed as well.
Primary Outcome
Measured at home using a standardized weighing procedure. Participants will be weighed in lightweight clothes without shoes using a standardized bluetooth scale accurate to 0.1 kg.
Conditions Studied
Interventions
- BEHAVIORAL Behavioral Treatment
- BEHAVIORAL Willingness
- BEHAVIORAL Values
- BEHAVIORAL Mindful Awareness
Study Locations (1)
Pennsylvania
- Drexel University Center for Weight, Eating and Lifestyle Science - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2024-11-07 |
| Phase | NA |
What the finished NCT04337619 record still lists
NCT04337619 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 4 interventions - of which Behavioral Treatment is the first listed.
NCT04337619 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04337619 about?
NCT04337619 is a clinical study titled "Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss". Mindfulness and Acceptance based Behavioral Therapies (MABTs) are among the most promising behavioral approaches for obesity, with two recent large trials showing that they achieve better initial weight loss and/or better weight loss maintenance than does gold standard behavioral weight loss treatme...
What is the current status of trial NCT04337619?
This trial is currently completed. It is a NA study. The enrollment target is 276 participants. The study started on 2019-08-15. Estimated completion is 2024-11-07.
What conditions does trial NCT04337619 study?
This clinical trial studies the following conditions: Obesity, Weight Loss.
What interventions are being tested in trial NCT04337619?
The interventions under investigation include: Behavioral Treatment (BEHAVIORAL), Willingness (BEHAVIORAL), Values (BEHAVIORAL), Mindful Awareness (BEHAVIORAL).
Who is sponsoring clinical trial NCT04337619?
This trial is sponsored by Drexel University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04337619 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04337619's enrollment target sits among peer trials
276 242nd of 1053 higher than 812 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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