ObesityNCT05885438
ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women With Obesity
A study testing ACT workshop in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- ACT workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 13 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35205
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- ACT workshop
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT workshopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention group will receive the ACT workshop Receives: Behavioral: ACT workshop |
| Waitlist Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline and 1 month
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 1 month
Change from baseline in body weight at 1 week
Participants will be weighed to the nearest 0.1 kg.
Measured: baseline and 1 week
Change from baseline in body weight at 1 month
Participants will be weighed to the nearest 0.1 kg.
Measured: baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start31 Aug 2023
- Primary completion13 Jun 2025
- Study completion13 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Davis, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885438
- Sponsor's protocol ID
- IRB-300010404
- Status last verified
- Sep 2025
- First submitted
- 22 May 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women With Obesity
- ClinicalTrials.gov ID
- NCT05885438
- Acronym / sponsor ID
- IRB-300010404
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jul 2025 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ACT workshopParticipants in the intervention group will receive the ACT workshop |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT workshopThis workshop is a brief behavioral intervention that teaches acceptance and commitment therapy skills (e.g., values clarification, acceptance, committed action) to approach healthy living. | Behavioural | Intervention |
Primary outcome
Change from baseline in psychological flexibility at Week 1
Time frame: 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.
Change from baseline in distress tolerance at Week 1
Time frame: 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
Change from baseline in valued living at Week 1
Time frame: 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.
Change from baseline in psychological flexibility at 1 month
Time frame: 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.
Change from baseline in distress tolerance at 1 month
Time frame: 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
Change from baseline in valued living at 1 month
Time frame: 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.
12 secondary outcomes
Change from baseline in weight self-stigma at Week 1
Time frame: baseline and 1 week
Change from baseline in weight self-stigma at 1 month
Time frame: baseline and 1 month
Change from baseline in body image at Week 1
Time frame: baseline and 1 week
Change from baseline in body image at Month 1
Time frame: baseline and 1 month
Change from baseline in emotional eating at Week 1
Time frame: baseline and 1 week
Change from baseline in emotional eating at 1 month
Time frame: baseline and 1 month
Change from baseline in physical activity at Week 1
Time frame: baseline and 1 week
Change from baseline in physical activity at 1 month
Time frame: baseline and 1 month
Change from baseline in diet quality at Week 1
Time frame: baseline and 1 week
Change from baseline in diet quality at 1 month
Time frame: baseline and 1 month
Change from baseline in body weight at 1 week
Time frame: baseline and 1 week
Change from baseline in body weight at 1 month
Time frame: baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT workshop in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in psychological flexibility at Week 1 (time frame: Baseline and 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.