- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Doaa Kadhim Sabbar Sabbar, PhD
- Numéro de téléphone: +9467804600745
- E-mail: doaa.kazem1206a@conursing.uobaghdad.edu.iq
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Aucune 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Weight Management Behavior Scores Measured by TTM-Based Questionnaires
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Weight Management
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .