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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05885438
Collaborator
(none)
70
2
18

Study Details

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:

  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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACT workshop
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women With Obesity
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Participants in the intervention group will receive the ACT workshop

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in psychological flexibility at Week 1 [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.

  2. Change from baseline in distress tolerance at Week 1 [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

  3. Change from baseline in valued living at Week 1 [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.

  4. Change from baseline in psychological flexibility at 1 month [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.

  5. Change from baseline in distress tolerance at 1 month [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

  6. Change from baseline in valued living at 1 month [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.

Secondary Outcome Measures

  1. Change from baseline in weight self-stigma at Week 1 [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.

  2. Change from baseline in weight self-stigma at 1 month [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.

  3. Change from baseline in body image at Week 1 [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.

  4. Change from baseline in body image at Month 1 [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.

  5. Change from baseline in emotional eating at Week 1 [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.

  6. Change from baseline in emotional eating at 1 month [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.

  7. Change from baseline in physical activity at Week 1 [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.

  8. Change from baseline in physical activity at 1 month [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.

  9. Change from baseline in diet quality at Week 1 [baseline and 1 week]

    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.

  10. Change from baseline in diet quality at 1 month [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.

  11. Change from baseline in body weight at 1 week [baseline and 1 week]

    Participants will be weighed to the nearest 0.1 kg.

  12. Change from baseline in body weight at 1 month [baseline and 1 month]

    Participants will be weighed to the nearest 0.1 kg.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Davis, Graduate Student, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05885438
Other Study ID Numbers:
  • IRB-300010404
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023