- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Doaa Kadhim Sabbar Sabbar, PhD
- Número de teléfono: +9467804600745
- Correo electrónico: doaa.kazem1206a@conursing.uobaghdad.edu.iq
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Weight Management Behavior Scores Measured by TTM-Based Questionnaires
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Weight Management
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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