- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01043614
Peer Education, Exercising and Eating Right - Obesity Prevention in Freshmen Women (ProjectPEER)
Project PEER: Peer Education, Exercising and Eating Right
Project PEER utilizes a randomized controlled study design to investigate the combined effects of an exercise and nutrition intervention that is based on self-efficacy principles and delivered primarily by peer educators to reduce the risk for obesity in female college freshman over one academic year (N = 300). The control group will receive minimal interaction from the research team, paralleling the typical freshman experience on the UIUC campus. Recruitment will take place in two waves (consecutive fall terms with n = 150).
During the final year (Fall 2010) of the project, a General Education course will be offered that targets weight management. Importantly, the discussion groups for this course will be taught by peer educators trained using the peer resources further refined during the PEER project. In addition to conventional measures of content knowledge assessed in the college classroom when obtaining class credit, personal physical activity and nutrition behaviors along with behavioral determinants (self-efficacy, self-regulatory skills and outcome expectations) will also be assessed.
Primary Aim 1: To determine the effectiveness of a peer-delivered self efficacy-based behavioral intervention to enhance nutrition and physical activity behaviors and subsequently weight management success in female university freshman over one academic year. We hypothesize that freshmen randomized to the intervention group will be more successful in losing or maintaining weight than the control group through a combination of diet and physical activity strategies.
Primary Aim 2: To examine the role played by social cognitive factors in changing nutrition and physical activity behaviors across one academic year. We hypothesize that self-efficacy will have both a direct influence on behavior and an indirect effect through its influence on self-regulatory skills and outcome expectations.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Illinois
-
Urbana, Illinois, Estados Unidos, 61801
- University of Illinois at Urbana-Champaign
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female
- In first year on campus, enrolled full-time, and in residence on the UIUC campus
- Aged 17-19 yrs (minors will be required to obtain parental signature on the IRB form)
- Free from any chronic disease/condition that would alter ability to exercise or preclude diet manipulation such as diabetes, hypertension or pregnancy.
- Free from an eating disorder as assessed using the Eating Disorder Inventory
- Free from any medications that would alter adiposity or psychological outcomes
- Sedentary or participation in non-professional recreational activity
- Non-smoking
- Body mass index (BMI) between the 50th and 95th BMI-for-age percentile
Exclusion Criteria:
- Male
- Status other than freshman or enrolled for entire year
- Not living on campus
- Smoking
- Pregnant
- Competitive athlete
- Chronic condition that would alter ability to exercise or preclude diet manipulation such as diabetes, hypertension
- Eating disorder as assessed using the Eating Disorder Inventory
- Taking medications that would alter adiposity or psychological outcomes
- Participation in competitive athletics
- BMI outside parameters
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: Peer group education
Small groups of female college freshmen facilitated by peer educators
|
An exercise and nutrition intervention that is based on self-efficacy principles and delivered primarily by peer educators to reduce the risk for obesity in female college freshman over one academic year
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Anthropometric measures (eg; weight, hip/ waist dimensions)
Periodo de tiempo: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Self-efficacy measures for physical activity, nutrition
Periodo de tiempo: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ellen M Evans, PhD, Uiversity of Illinois at Urbana- Champaign
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2007-04574
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .