- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337619
Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss (Activate)
February 19, 2024 updated by: Evan Forman, Drexel University
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 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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
285
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Drexel University Center for Weight, Eating and Lifestyle Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard Behavioral Weight Loss Treatment
|
Standard Behavioral Weight Loss Treatment (remotely delivered)
|
Experimental: Behavioral + Mindful Acceptance
|
Standard Behavioral Weight Loss Treatment (remotely delivered)
Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Experimental: Behavioral + Values
|
Standard Behavioral Weight Loss Treatment (remotely delivered)
Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Experimental: Behavioral + Mindful Awareness
|
Standard Behavioral Weight Loss Treatment (remotely delivered)
Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Experimental: Behavioral + Acceptance + Values
|
Standard Behavioral Weight Loss Treatment (remotely delivered)
Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
|
Experimental: Behavioral + Acceptance + Awareness
|
Standard Behavioral Weight Loss Treatment (remotely delivered)
Integration of acceptance and willingness 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).
|
Experimental: Behavioral + Values + Awareness
|
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).
|
Experimental: Behavioral + Acceptance + Values + Awareness
|
Standard Behavioral Weight Loss Treatment (remotely delivered)
Integration of acceptance and willingness skills into 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary intake
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).
|
Measured with a 25-item Food Frequency Questionnaire developed by the research team for this study.
|
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).
|
Physical activity
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).
|
Measured in minutes per week of moderate-to-vigorous physical activity (MVPA) using the FitBit Charge 2, 3, 4, and 5, consumer-grade wrist-worn activity trackers utilized in several other studies.
|
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).
|
Change in quality of life
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).
|
Measured using the Quality of Life Inventory (QOLI).
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Evan M Forman, PhD, Drexel University Center for Weight, Eating and Lifestyle Science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2019
Primary Completion (Estimated)
October 31, 2024
Study Completion (Estimated)
October 31, 2024
Study Registration Dates
First Submitted
February 25, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (Actual)
April 7, 2020
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 19, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK119658 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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