NCT05885438

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. 1.To assess changes in ACT-related constructs before and after the workshop
  2. 2.To assess changes in other psychological constructs that have been shown to hinder successful weight management before and after the workshop
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

May 22, 2023

Last Update Submit

September 11, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (12)

  • Change from baseline in weight self-stigma at Week 1

    baseline and 1 week

  • Change from baseline in weight self-stigma at 1 month

    baseline and 1 month

  • Change from baseline in body image at Week 1

    baseline and 1 week

  • Change from baseline in body image at Month 1

    baseline and 1 month

  • Change from baseline in emotional eating at Week 1

    baseline and 1 week

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention group will receive the ACT workshop

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.

Interventions

ACT workshopBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants who self-identify as women will be eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 2, 2023

Study Start

August 31, 2023

Primary Completion

June 13, 2025

Study Completion

July 13, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations