Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Drexel University
Study ID
NCT04337619
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Treatment — BEHAVIORAL
    Standard Behavioral Weight Loss Treatment (remotely delivered)
  • Willingness — BEHAVIORAL
    Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
  • Values — BEHAVIORAL
    Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
  • Mindful Awareness — BEHAVIORAL
    Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).

Study Details

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.

Key Dates

Start date
Aug 15, 2019
Status verified
Mar 2026
Primary completion
Nov 7, 2024
Completion
Nov 7, 2024

Study Design

Enrollment
276 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard Behavioral Weight Loss Treatment
  • Experimental: Behavioral + Willingness
  • Experimental: Behavioral + Values
  • Experimental: Behavioral + Mindful Awareness
  • Experimental: Behavioral + Willingness + Values
  • Experimental: Behavioral + Willingness + Awareness
  • Experimental: Behavioral + Values + Awareness
  • Experimental: Behavioral + Willingness + Values + Awareness

Primary Outcome Measure

Weight Change [ Time Frame: Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Drexel University Center for Weight, Eating and Lifestyle SciencePhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Drexel University Center for Weight, Eating and Lifestyle Science· Philadelphia, PA

Related Studies