Weight ManagementTTM-WMHSFS-RCTNCT07604649
TTM-Based Intervention for Weight Management Among High School Female Students
A study testing Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight Management in people with Weight Management, run by University of Baghdad.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Management
- What is being tested?
- Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 10 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Weight Management
- Being tested
- Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Intervention Group) | Experimental | 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. Receives: Behavioral: Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight Management |
| Control (No Intervention) | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight Management Behavior Scores Measured by TTM-Based Questionnaires
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Mar 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with two parallel groups: an intervention group receiving a Transtheoretical Model-based behavioral program and a control group receiving standard health education.
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Kadhim Sabbar, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604649
- Sponsor's protocol ID
- Weight Management
- Acronym
- TTM-WMHSFS-RCT
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Transtheoretical Model of Change-Based Intervention on Weight Management Behavior Among High School Female Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07604649
- Acronym / sponsor ID
- TTM-WMHSFS-RCT / Weight Management
- Conditions
- Weight Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 22 May 2026 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial with two parallel groups: an intervention group receiving a Transtheoretical Model-based behavioral program and a control group receiving standard health education.
| Arm | Type | Receives |
|---|---|---|
| Experimental (Intervention Group) | Experimental | Behavioral: Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight ManagementParticipants 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. |
| Control (No Intervention) | 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. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight ManagementThis 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. | Behavioural | Experimental (Intervention Group) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Transtheoretical Model (TTM)-Based Behavioral Intervention for Weight Management in people with Weight Management, run by University of Baghdad.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doaa Kadhim Sabbar Sabbar, PhD (+9467804600745, doaa.kazem1206a@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight Management Behavior Scores Measured by TTM-Based Questionnaires (time frame: 6 months). 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 22 May 2026.