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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT workshop
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Waitlist Control

Arm Description

Participants in the intervention group will receive the ACT workshop

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.

Outcomes

Primary Outcome Measures

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.
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
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.
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.
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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change from baseline in body weight at 1 week
Participants will be weighed to the nearest 0.1 kg.
Change from baseline in body weight at 1 month
Participants will be weighed to the nearest 0.1 kg.

Full Information

First Posted
May 22, 2023
Last Updated
August 31, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05885438
Brief Title
ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women With Obesity
Official Title
ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive the ACT workshop
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ACT workshop
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in psychological flexibility at Week 1
Description
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.
Time Frame
Baseline and 1 week
Title
Change from baseline in distress tolerance at Week 1
Description
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
Time Frame
baseline and 1 week
Title
Change from baseline in valued living at Week 1
Description
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.
Time Frame
baseline and 1 week
Title
Change from baseline in psychological flexibility at 1 month
Description
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.
Time Frame
baseline and 1 month
Title
Change from baseline in distress tolerance at 1 month
Description
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
Time Frame
baseline and 1 month
Title
Change from baseline in valued living at 1 month
Description
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.
Time Frame
baseline and 1 month
Secondary Outcome Measure Information:
Title
Change from baseline in weight self-stigma at Week 1
Description
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.
Time Frame
baseline and 1 week
Title
Change from baseline in weight self-stigma at 1 month
Description
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.
Time Frame
baseline and 1 month
Title
Change from baseline in body image at Week 1
Description
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.
Time Frame
baseline and 1 week
Title
Change from baseline in body image at Month 1
Description
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.
Time Frame
baseline and 1 month
Title
Change from baseline in emotional eating at Week 1
Description
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.
Time Frame
baseline and 1 week
Title
Change from baseline in emotional eating at 1 month
Description
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.
Time Frame
baseline and 1 month
Title
Change from baseline in physical activity at Week 1
Description
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.
Time Frame
baseline and 1 week
Title
Change from baseline in physical activity at 1 month
Description
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.
Time Frame
baseline and 1 month
Title
Change from baseline in diet quality at Week 1
Description
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.
Time Frame
baseline and 1 week
Title
Change from baseline in diet quality at 1 month
Description
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.
Time Frame
baseline and 1 month
Title
Change from baseline in body weight at 1 week
Description
Participants will be weighed to the nearest 0.1 kg.
Time Frame
baseline and 1 week
Title
Change from baseline in body weight at 1 month
Description
Participants will be weighed to the nearest 0.1 kg.
Time Frame
baseline and 1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants who self-identify as women will be eligible to participate.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea L Davis, MA
Phone
(205) 934-8723
Email
andrealdavis@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gareth Dutton, PhD
Phone
(205) 934-6876
Email
gdutton@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Davis, MA
Phone
205-206-9434
Email
andrealdavis@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Gareth R Dutton, PhD
Phone
2059346876
Email
gdutton@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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