- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05885438
ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women With Obesity
September 11, 2025 updated by: Andrea Davis, University of Alabama at Birmingham
The goal of this clinical trial is to investigate if a 4-hour acceptance and commitment therapy workshop can help the adoption and maintenance of healthy lifestyle behaviors in women with obesity. The objectives are as follows:
- To assess changes in ACT-related constructs before and after the workshop
- To assess changes in other psychological constructs that have been shown to hinder successful weight management before and after the workshop
- To assess changes in dietary and physical activity behaviors before and after the workshop. Participants will complete baseline questionnaires and anthropometric measures at three time points: baseline, 1 week after the workshop, and 1 month after the workshop. Researchers will compare an active intervention group to a waitlist control group to investigate the efficacy of the workshop.
Study Overview
Detailed Description
Acceptance and commitment therapy interventions demonstrate efficacy for weight loss.
ACT-based workshops represent an innovative and potentially scalable application of this approach to obesity treatment.
70 women will be recruited to participate.
Half of the participants (n = 35) will receive a brief ( approximately 4-hour) workshop that aims to facilitate the development and maintenance of healthy lifestyle behaviors using ACT principles such as valued living and committed action.
Outcomes will be assessed at baseline, 1-week, and 1-month post-intervention.
Study Type
Interventional
Enrollment (Actual)
52
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
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Alabama
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Birmingham, Alabama, United States, 35205
- University of Alabama at Birmingham
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-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Inclusion criteria will be individuals who self-identify as women, have a BMI of >30.0 kg/m2 based on self-reported height and weight, are able to read and understand written and spoken English, and have a primary residence within 50 miles driving distance of the University of Alabama at Birmingham campus.
Exclusion Criteria:
- Exclusion criteria will include presence of eating disorder symptoms (assessed by participant self-report for a former or current diagnosis) presence of a major mood disorder (assessed by participant self-report of a current or former diagnosis), recent weight change of +/-10 pounds, recent use of prescription medication for weight loss, and current participation in another weight management program.
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants in the intervention group will receive the ACT workshop
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This workshop is a brief behavioral intervention that teaches acceptance and commitment therapy skills (e.g., values clarification, acceptance, committed action) to approach healthy living.
|
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No Intervention: Waitlist Control
Participants in the waitlist control group will not receive the intervention until all members of the intervention group have received the workshop.
Once all members of the intervention group have received the workshop, participants in the waitlist control group will be able to receive the workshop if they so desire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in psychological flexibility at Week 1
Time Frame: Baseline and 1 week
|
The Acceptance and Action Questionnaire for Weight-Related Difficulties is a validated, self-report measure and will be used to assess change in psychological flexibility.
Possible scores range from 0-22, with higher scores indicating greater psychological flexibility.
|
Baseline and 1 week
|
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Change from baseline in distress tolerance at Week 1
Time Frame: baseline and 1 week
|
Distress tolerance will be measured using the Distress Tolerance Scale- Short Form (DTS), a validated, self-report measure.
Possible scores range from 15 to 75, with higher scores indicating better distress tolerance
|
baseline and 1 week
|
|
Change from baseline in valued living at Week 1
Time Frame: baseline and 1 week
|
The Valued Living Questionnaire is a validated, self-report measure to assess the extent to which an individual is living in a way that is consistent with their core values.
Scores range from 10-100, with higher scores indicating greater consistency between values and behavior.
|
baseline and 1 week
|
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Change from baseline in psychological flexibility at 1 month
Time Frame: baseline and 1 month
|
The Acceptance and Action Questionnaire for Weight-Related Difficulties is a validated, self-report measure and will be used to assess change in psychological flexibility.
Possible scores range from 0-22, with higher scores indicating greater psychological flexibility.
|
baseline and 1 month
|
|
Change from baseline in distress tolerance at 1 month
Time Frame: baseline and 1 month
|
Distress tolerance will be measured using the Distress Tolerance Scale- Short Form (DTS), a validated, self-report measure.
Possible scores range from 15 to 75, with higher scores indicating better distress tolerance
|
baseline and 1 month
|
|
Change from baseline in valued living at 1 month
Time Frame: baseline and 1 month
|
The Valued Living Questionnaire is a validated, self-report measure to assess the extent to which an individual is living in a way that is consistent with their core values.
Scores range from 10-100, with higher scores indicating greater consistency between values and behavior.
|
baseline and 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in weight self-stigma at Week 1
Time Frame: baseline and 1 week
|
Weight self-stigma will be measured using the Weight Self-Stigma Questionnaire, a validated self-report measure.
This is a 23-item measure, with scores ranging from 12- 60. higher scores indicate more weight self-stigma.
|
baseline and 1 week
|
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Change from baseline in weight self-stigma at 1 month
Time Frame: baseline and 1 month
|
Weight self-stigma will be measured using the Weight Self-Stigma Questionnaire, a validated self-report measure.
This is a 23-item measure, with scores ranging from 12- 60. higher scores indicate more weight self-stigma.
|
baseline and 1 month
|
|
Change from baseline in body image at Week 1
Time Frame: baseline and 1 week
|
Body image will be measured using the Body Shape Questionnaire, a validated, 14 item self report measure.
Scores range from 14 to 84, with higher scores indicating more negative body image.
|
baseline and 1 week
|
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Change from baseline in body image at Month 1
Time Frame: baseline and 1 month
|
Body image will be measured using the Body Shape Questionnaire, a validated, 14 item self report measure.
Scores range from 14 to 84, with higher scores indicating more negative body image.
|
baseline and 1 month
|
|
Change from baseline in emotional eating at Week 1
Time Frame: baseline and 1 week
|
Emotional eating will be measured using the Emotional Eating Scale.
This is a 25 item self-report measure with possible scores ranging from 25 to 125.
Higher scores suggest greater likelihood to eat in response to emotionality.
|
baseline and 1 week
|
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Change from baseline in emotional eating at 1 month
Time Frame: baseline and 1 month
|
Emotional eating will be measured using the Emotional Eating Scale.
This is a 25 item self-report measure with possible scores ranging from 25 to 125.
Higher scores suggest greater likelihood to eat in response to emotionality.
|
baseline and 1 month
|
|
Change from baseline in physical activity at Week 1
Time Frame: baseline and 1 week
|
Physical Activity will be measured using the International Physical Activity Questionnaire -Short Form.
This is a validated self report measure that provides information on frequency (times per week) and duration (minutes per session) of physical activity undertaken per week.
|
baseline and 1 week
|
|
Change from baseline in physical activity at 1 month
Time Frame: baseline and 1 month
|
Physical Activity will be measured using the International Physical Activity Questionnaire -Short Form.
This is a validated self report measure that provides information on frequency (times per week) and duration (minutes per session) of physical activity undertaken per week.
|
baseline and 1 month
|
|
Change from baseline in diet quality at Week 1
Time Frame: baseline and 1 week
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Dietary quality will be measured using the Rapid Eating Assessment for Participants- Shortened Version (REAPS-S).
The REAPS-S is a 16-item, self-report questionnaire with possible scores ranging from 16 - 48, with lower scores indicating a less healthy diet.
|
baseline and 1 week
|
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Change from baseline in diet quality at 1 month
Time Frame: baseline and 1 month
|
Dietary quality will be measured using the Rapid Eating Assessment for Participants- Shortened Version (REAPS-S).
The REAPS-S is a 16-item, self-report questionnaire with possible scores ranging from 16 - 48, with lower scores indicating a less healthy diet.
|
baseline and 1 month
|
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Change from baseline in body weight at 1 week
Time Frame: baseline and 1 week
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Participants will be weighed to the nearest 0.1 kg.
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baseline and 1 week
|
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Change from baseline in body weight at 1 month
Time Frame: baseline and 1 month
|
Participants will be weighed to the nearest 0.1 kg.
|
baseline and 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 31, 2023
Primary Completion (Actual)
June 13, 2025
Study Completion (Actual)
July 13, 2025
Study Registration Dates
First Submitted
May 22, 2023
First Submitted That Met QC Criteria
May 22, 2023
First Posted (Actual)
June 2, 2023
Study Record Updates
Last Update Posted (Estimated)
September 12, 2025
Last Update Submitted That Met QC Criteria
September 11, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300010404
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
product manufactured in and exported from the U.S.
No
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