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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 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.

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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.

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

FieldValue
Enrollment Target 276 participants
Start Date 2019-08-15
Est. Completion 2024-11-07
Phase NA

Sponsor

Drexel University

92 total trials

What the Registry Record Tells You About NCT04337619

The ClinicalTrials.gov registry entry for NCT04337619 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 276 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 (66% lower). The listed sponsor is Drexel University, which has 92 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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