- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07604649
TTM-Based Intervention for Weight Management Among High School Female Students (TTM-WMHSFS-RCT)
Efficacy of the Transtheoretical Model of Change-Based Intervention on Weight Management Behavior Among High School Female Students: A Randomized Controlled Trial
To examine the efficacy of a Transtheoretical Model (TTM)-based intervention in improving weight management behaviors.
- To identify if the student age, body mass index (BMI) and socioeconomic status can predict WMB.
- To investigate the difference in students' WMB between groups of grade, liven arrangement, socioeconomic class, and BMI.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doaa Kadhim Sabbar Sabbar, PhD
- Phone Number: +9467804600745
- Email: doaa.kazem1206a@conursing.uobaghdad.edu.iq
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female high school students
- Age 15-19 years
- Overweight or obese according to Body Mass Index (BMI) criteria
- Enrolled in high school morning classes
- Willing to participate in the study and provide informed consent
Exclusion Criteria:
- Students below high school level (e.g., middle school students)
- Students with physical disabilities that prevent participation in physical activity
- Students with chronic medical conditions affecting body weight or study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental (Intervention Group)
Participants in this arm will receive a structured behavioral intervention based on the Transtheoretical Model of behavior change.
The program includes stage-matched educational and counseling sessions designed to improve weight management behaviors.
Components include guidance on healthy eating, promotion of physical activity, goal setting, self-monitoring, and motivation enhancement according to each participant's readiness for change.
The intervention is non-pharmacological and has no known side effects.
|
This is a non-pharmacological, behavioral intervention designed to improve weight management behaviors among high school female students.
It is based on the Transtheoretical Model of behavior change and consists of structured, stage-matched educational and counseling sessions.
The intervention includes guidance on healthy dietary practices, promotion of regular physical activity, goal setting, self-monitoring techniques, and motivational strategies tailored to each participant's readiness to change.
|
|
No Intervention: Control (No Intervention)
Participants in this arm will receive routine school-based health education only.
This includes general information about healthy lifestyle practices such as balanced nutrition and physical activity.
No structured behavioral change program or stage-based intervention will be provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Weight Management Behavior Scores Measured by TTM-Based Questionnaires
Time Frame: 6 months
|
Change in Weight Management Behavior Scores Measured by TTM-Based Questionnaires: Weight Control Decisional Balance Scale (WCDBS): 20-item scale with scores ranging from -40 to +40. Higher positive scores indicate more favorable attitudes toward healthy weight management behaviors. Weight Control Processes of Change Scale (WCPOCS): 48-item scale with scores ranging from 48 to 240. Higher scores indicate greater engagement in healthy weight management behavior change processes. Stages of Change for Weight Control Scale (SCWCS): categorizes participants into precontemplation, contemplation, preparation, action, and maintenance stages. Higher stages indicate greater readiness for healthy weight management behavior change. The outcome will be reported as mean score changes and stage distribution differences between intervention and control groups. |
6 months
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Weight Management
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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