TTM-Based Intervention for Weight Management Among High School Female Students (TTM-WMHSFS-RCT)

May 19, 2026 updated by: Doaa Kadhim Sabbar, University of Baghdad

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.

  1. To identify if the student age, body mass index (BMI) and socioeconomic status can predict WMB.
  2. To investigate the difference in students' WMB between groups of grade, liven arrangement, socioeconomic class, and BMI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled trial aims to evaluate the efficacy of a Transtheoretical Model (TTM)-based behavioral intervention in improving weight management behaviors among high school female students. The intervention is designed to guide participants through the stages of behavior change, enhancing their readiness to adopt and maintain healthy lifestyle practices such as balanced nutrition, physical activity, and weight control behaviors. The study will compare outcomes between an intervention group receiving structured TTM-based sessions and a control group receiving standard health education. Primary outcomes will focus on changes in weight management behaviors, while secondary outcomes may include changes in stage of readiness for change, self-efficacy, and health-related attitudes. The findings are expected to provide evidence on the effectiveness of stage-based behavioral interventions in promoting healthy weight management among adolescent females.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight Management
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Weight Management

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Conditions

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Dietary Supplements

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