Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
Activate
Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
1 other identifier
interventional
276
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Aug 2019
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2019
CompletedFirst Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
April 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2024
CompletedResults Posted
Study results publicly available
March 11, 2026
CompletedMarch 11, 2026
March 1, 2026
5.2 years
February 25, 2020
January 20, 2026
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Change
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.
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).
Secondary Outcomes (3)
Dietary Intake
Measured at baseline, mid-treatment (6 months), post-treatment (12 months) (i.e., at 0, 6, and 12 months).
Physical Activity
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).
Quality of Life Score
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).
Study Arms (8)
Standard Behavioral Weight Loss Treatment
EXPERIMENTALBehavioral + Willingness
EXPERIMENTALBehavioral + Values
EXPERIMENTALBehavioral + Mindful Awareness
EXPERIMENTALBehavioral + Willingness + Values
EXPERIMENTALBehavioral + Willingness + Awareness
EXPERIMENTALBehavioral + Values + Awareness
EXPERIMENTALBehavioral + Willingness + Values + Awareness
EXPERIMENTALInterventions
Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Standard Behavioral Weight Loss Treatment (remotely delivered)
Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Eligibility Criteria
You may qualify if:
- Individuals must be of overweight or obese BMI (27-50 kg/m2)
- Individuals must be adults (aged 18-70)
- Completion of a 3-day food diary
- Completion of baseline assessment tasks
- Willingness to lose weight, be physically active, and participate in-group sessions.
- Participants must also provide consent for the research team to contact their personal physician if necessary to provide clearance or to consult about rapid weight gain.
You may not qualify if:
- Inability to engage in physical activity (defined as walking a city block without stopping)
- Medical or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the program
- Recently began or changed the dose of a medication that can cause significant change in weight
- History of bariatric surgery; weight loss of \> 5% in the previous 3 months
- Currently pregnant or breastfeeding or planning to become pregnant
- Planning to, or participating in, another weight loss treatment in the next 3 years.
- Engaging in compensatory vomiting, other severe compensatory behaviors, or more than 12 of any compensatory behavior in the previous 3 months
- Experiencing significant loss of control eating (9 or more binge episodes in the previous 3 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drexel University Center for Weight, Eating and Lifestyle Science
Philadelphia, Pennsylvania, 19104, United States
Related Publications (3)
Crochiere RJ, Fitzgerald DT, Butryn ML, Zhang F, Beaulieu K, Maher JP, Huang Z, Cong C, Forman EM. Moderators of the relation between physical activity and subsequent energy intake among behavioral weight loss participants. Health Psychol. 2026 Mar 5. doi: 10.1037/hea0001597. Online ahead of print.
PMID: 41785111DERIVEDChabria R, Hagerman CJ, Crane N, Ehmann M, Knudsen FM, Brown KL, Forman E, Butryn ML. Racial disparities in the efficacy of traditional versus acceptance-based behavioral weight loss. Health Psychol. 2026 Feb;45(2):197-205. doi: 10.1037/hea0001537. Epub 2025 Jul 24.
PMID: 40705619DERIVEDCrochiere RJ, Butryn ML, Zhang F, Beaulieu K, Maher JP, Huang Z, Cong C, Forman EM. Intraday relations between physical activity and energy intake among behavioral weight loss participants. Health Psychol. 2024 May;43(5):376-387. doi: 10.1037/hea0001358. Epub 2024 Jan 8.
PMID: 38190202DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Average daily calorie intake was not analyzed as an outcome or included in the imputation model because this measure is expected to be strongly biased by participants' adherence to food tracking and inaccuracies in calorie estimation (Butryn et al., 2020; Mixon and Davis, 2020).
Results Point of Contact
- Title
- Fengqing Zhang
- Organization
- Drexel University
Study Officials
- PRINCIPAL INVESTIGATOR
Evan M Forman, PhD
Drexel University Center for Weight, Eating and Lifestyle Science
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2020
First Posted
April 7, 2020
Study Start
August 15, 2019
Primary Completion
November 7, 2024
Study Completion
November 7, 2024
Last Updated
March 11, 2026
Results First Posted
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share