ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women With Obesity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: ACT workshop


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in the intervention group will receive the ACT workshop | Behavioral: ACT workshop<br>* 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.<br>|
| No Intervention: Waitlist Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in psychological flexibility at Week 1 | 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 | 
| Change from baseline in distress tolerance at Week 1 | 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 | 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 | 
| Change from baseline in psychological flexibility at 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 | 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 | 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 | 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 | 
| Change from baseline in weight self-stigma at 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 | 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 | 
| Change from baseline in body image at Month 1 | 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 | 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 | 
| Change from baseline in emotional eating at 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 | 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 | 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 | 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 | 
| Change from baseline in diet quality at 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 | 
| Change from baseline in body weight at 1 week | Participants will be weighed to the nearest 0.1 kg. | baseline and 1 week | 
| Change from baseline in body weight at 1 month | Participants will be weighed to the nearest 0.1 kg. | baseline and 1 month |