- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07817849
Online Acceptance and Commitment Therapy-Based Physical Literacy Program for Socioeconomically Disadvantaged Women Living With Overweight
Effects of a Brief Online Acceptance and Commitment Therapy-Based Physical Literacy Program in Socioeconomically Disadvantaged Women Living With Overweight: A Randomized Controlled Trial
This two-group, parallel, individually randomized controlled trial will evaluate a brief, live, online Acceptance and Commitment Therapy (ACT)-based physical literacy program among 60 socioeconomically disadvantaged adult women living with overweight. Participants will be randomized in a 1:1 ratio to either the intervention group or a waitlist control group.
The intervention consists of six weekly approximately 60-minute online group sessions integrating the six ACT processes with adult physical literacy education, guided movement, and graded home-based exercise snacks, followed by an independent-practice week and an approximately 60-minute booster session. Assessments will be conducted at baseline, immediately before the booster following completion of the six core sessions, and at post-booster follow-up. The study will compare changes between the intervention and waitlist control groups over the study period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayla Rezvan Reha, PhD
- Phone Number: +905340571233
- Email: aylarezvanreha@aydin.edu.tr
Study Locations
-
-
Avcilar
-
Istanbul, Avcilar, Turkey (Türkiye)
- Recruiting
- Online
-
Contact:
- Navid Reha, PhD
- Phone Number: +905350223304
- Email: navidrha@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eligibility required: (a) age 18 to 64 years old; (b) residence in Gümüşpala, Avcılar, Istanbul; (c) BMI of 25.0-29.9 kg/m²; (d) annual equivalized net disposable household income below TRY 144,690, the 60%-of-median threshold in the 2025 Turkish Statistical Institute poverty statistics, based on the 2024 income reference period (Turkish Statistical Institute, 2025); (e) no completion of high school (ISCED Levels 0-2; UNESCO Institute for Statistics, 2012); (f) ability to read and understand Turkish; (g) access to a smartphone, WhatsApp, and the internet; (h) willingness to complete all assessments; and (i) written informed consent.
Exclusion Criteria:
- pregnancy or childbirth within the previous six months; a medical or musculoskeletal condition, or professional advice, precluding or substantially restricting physical activity; concurrent participation in another structured weight-management, physical-activity, or psychological intervention; a cognitive or psychiatric condition substantially limiting comprehension or informed consent; or inability to complete study assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist Control
|
|
|
Experimental: ACT-Based Physical Literacy Program
|
Participants receive the live online ACT-based physical literacy program consisting of six weekly approximately 60-minute group sessions, an independent-practice week, and an approximately 60-minute booster session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change From Baseline in Physical Literacy Scale for Adults (PLAS) Total Score
Time Frame: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change From Baseline in PERMA-Profiler Overall Well-Being Score
Time Frame: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
|
Change From Baseline in Psy-Flex Scale Score
Time Frame: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
|
Change From Baseline in Total Physical Activity Measured by the Global Physical Activity Questionnaire (GPAQ)
Time Frame: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
|
Change From Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
|
Change From Baseline in Waist Circumference
Time Frame: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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