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

Not Applicable

Active, not recruiting

• Conditions: Obesity; Weight Loss
• Interventions: Behavioral: Behavioral Treatment; Behavioral: Values; Behavioral: Mindful Acceptance; Behavioral: Mindful Awareness

• Registration Number: NCT04337619
• Lead Sponsor: Drexel University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-15
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 285

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Behavioral + Values + Awareness	Mindful Awareness	-
Behavioral + Values	Values	-
Behavioral + Mindful Acceptance	Behavioral Treatment	-
Behavioral + Acceptance + Values	Mindful Acceptance	-
Behavioral + Acceptance + Awareness	Behavioral Treatment	-
Behavioral + Values + Awareness	Behavioral Treatment	-
Behavioral + Acceptance + Values + Awareness	Behavioral Treatment	-
Standard Behavioral Weight Loss Treatment	Behavioral Treatment	-
Behavioral + Acceptance + Values	Behavioral Treatment	-
Behavioral + Mindful Awareness	Mindful Awareness	-
Behavioral + Values	Behavioral Treatment	-
Behavioral + Mindful Awareness	Behavioral Treatment	-
Behavioral + Acceptance + Awareness	Mindful Acceptance	-
Behavioral + Acceptance + Awareness	Mindful Awareness	-
Behavioral + Acceptance + Values + Awareness	Mindful Acceptance	-
Behavioral + Mindful Acceptance	Mindful Acceptance	-
Behavioral + Acceptance + Values	Values	-
Behavioral + Values + Awareness	Values	-
Behavioral + Acceptance + Values + Awareness	Values	-
Behavioral + Acceptance + Values + Awareness	Mindful Awareness	-

Primary Outcome Measures

Name	Time	Method
Weight change	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.

Secondary Outcome Measures

Name	Time	Method
Dietary intake	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.
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).	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.
Change in quality of life	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).

Trial Locations

Locations (1)

Drexel University Center for Weight, Eating and Lifestyle Science; 🇺🇸 Philadelphia, Pennsylvania, United States