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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885438
• Other study ID #: IRB-300010404
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: Andrea L Davis, MA
• Phone: (205) 934-8723
• Email: andrealdavis[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. To assess changes in ACT-related constructs before and after the workshop

2. To assess changes in other psychological constructs that have been shown to hinder successful weight management before and after the workshop

3. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• ACT workshop
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in body weight at 1 week	Participants will be weighed to the nearest 0.1 kg.	baseline and 1 week
Secondary	Change from baseline in body weight at 1 month	Participants will be weighed to the nearest 0.1 kg.	baseline and 1 month