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

Primary Purpose

Obesity, Weight Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Treatment
Mindful Acceptance
Values
Mindful Awareness
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss, Behavioral treatment, Acceptance-based behavioral weight loss treatment, Acceptance and Commitment Therapy, Multiphase Optimization Strategy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Drexel University Center for Weight, Eating and Lifestyle Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Standard Behavioral Weight Loss Treatment

Behavioral + Mindful Acceptance

Behavioral + Values

Behavioral + Mindful Awareness

Behavioral + Acceptance + Values

Behavioral + Acceptance + Awareness

Behavioral + Values + Awareness

Behavioral + Acceptance + Values + Awareness

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dietary intake
Measured with a 25-item Food Frequency Questionnaire developed by the research team for this study.
Physical activity
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 using the Quality of Life Inventory (QOLI).

Full Information

First Posted
February 25, 2020
Last Updated
March 10, 2022
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT04337619
Brief Title
Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
Acronym
Activate
Official Title
Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Weight Loss, Behavioral treatment, Acceptance-based behavioral weight loss treatment, Acceptance and Commitment Therapy, Multiphase Optimization Strategy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Behavioral Weight Loss Treatment
Arm Type
Experimental
Arm Title
Behavioral + Mindful Acceptance
Arm Type
Experimental
Arm Title
Behavioral + Values
Arm Type
Experimental
Arm Title
Behavioral + Mindful Awareness
Arm Type
Experimental
Arm Title
Behavioral + Acceptance + Values
Arm Type
Experimental
Arm Title
Behavioral + Acceptance + Awareness
Arm Type
Experimental
Arm Title
Behavioral + Values + Awareness
Arm Type
Experimental
Arm Title
Behavioral + Acceptance + Values + Awareness
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Treatment
Intervention Description
Standard Behavioral Weight Loss Treatment (remotely delivered)
Intervention Type
Behavioral
Intervention Name(s)
Mindful Acceptance
Intervention Description
Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Intervention Type
Behavioral
Intervention Name(s)
Values
Intervention Description
Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Intervention Type
Behavioral
Intervention Name(s)
Mindful Awareness
Intervention Description
Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
Primary Outcome Measure Information:
Title
Weight change
Description
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.
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).
Secondary Outcome Measure Information:
Title
Dietary intake
Description
Measured with a 25-item Food Frequency Questionnaire developed by the research team for this study.
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).
Title
Physical activity
Description
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.
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).
Title
Change in quality of life
Description
Measured using the Quality of Life Inventory (QOLI).
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan M Forman, PhD
Organizational Affiliation
Drexel University Center for Weight, Eating and Lifestyle Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University Center for Weight, Eating and Lifestyle Science
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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