CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 276 enrolled
Drug / intervention
Behavioral Treatment +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04337619
NCT04337619N/ACompleted

Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss

Drexel University·interventional·Posted Apr 7, 2020·Updated Mar 11, 2026

In Brief

A clinical study evaluating Behavioral Treatment, Willingness, and 2 other interventions for Obesity and Weight Loss. Completed, enrolled 276 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Weight Loss
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 7, 2020
Enrollment StartAug 15, 2019
Primary CompletionNov 7, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 6.2 years ago

Interventions

Behavioral Treatmentbehavioral

Standard Behavioral Weight Loss Treatment (remotely delivered)

Willingnessbehavioral

Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).

Valuesbehavioral

Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).

Mindful Awarenessbehavioral

Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).