Clinical trial NCT05885438: 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
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Change from baseline in psychological flexibility at Week 1
timeFrame: Baseline and 1 week
measure: Change from baseline in distress tolerance at Week 1
timeFrame: baseline and 1 week
measure: Change from baseline in valued living at Week 1
timeFrame: baseline and 1 week
measure: Change from baseline in psychological flexibility at 1 month
timeFrame: baseline and 1 month
measure: Change from baseline in distress tolerance at 1 month
timeFrame: baseline and 1 month
measure: Change from baseline in valued living at 1 month
timeFrame: baseline and 1 month
Secondary outcomes:
measure: Change from baseline in weight self-stigma at Week 1
timeFrame: baseline and 1 week
measure: Change from baseline in weight self-stigma at 1 month
timeFrame: baseline and 1 month
measure: Change from baseline in body image at Week 1
timeFrame: baseline and 1 week
measure: Change from baseline in body image at Month 1
timeFrame: baseline and 1 month
measure: Change from baseline in emotional eating at Week 1
timeFrame: baseline and 1 week
measure: Change from baseline in emotional eating at 1 month
timeFrame: baseline and 1 month
measure: Change from baseline in physical activity at Week 1
timeFrame: baseline and 1 week
measure: Change from baseline in physical activity at 1 month
timeFrame: baseline and 1 month
measure: Change from baseline in diet quality at Week 1
timeFrame: baseline and 1 week
measure: Change from baseline in diet quality at 1 month
timeFrame: baseline and 1 month
measure: Change from baseline in body weight at 1 week
timeFrame: baseline and 1 week
measure: Change from baseline in body weight at 1 month
timeFrame: baseline and 1 month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: