- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01402557
Telehealth for Weight Maintenance of African-American Women ("Exercise Your Faith")
Telehealth for Weight Maintenance of African-American Women
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rates of obesity in the United States have increased dramatically over the past four decades. Although research studies have demonstrated that weight loss is achievable through lifestyle modifications, the maintenance of weight reduction beyond six months remains a challenge.
This study will examine the feasibility of a telehealth program for weight maintenance. Telehealth is the delivery of health related services to promote healthy behaviors through the innovative use of technology, without the need for travel. The telehealth program will be accessible at home through Internet-enabled television sets. The telehealth program includes three components: (1) weekly video programs that discuss problem solving and relapse prevention strategies and include motivational stories; (2) regularly updated video exercise programs; and (3) online communication with other study participants and an exercise and nutrition specialist.
A randomized controlled trial will determine the feasibility and acceptability of the weight maintenance telehealth program. The study participants will be African-American women, as they have a higher prevalence of obesity with a disproportionate risk of related chronic diseases (e.g., diabetes). Two churches will collaborate with the University of Illinois at Chicago and assist in meeting the social, spiritual, and cultural needs of the participants. One hundred women will be recruited to participate in a one-year trial. The study includes a weight loss phase (Phase 1), and a weight maintenance phase (Phase 2). During Phase 1, all participants will attend a 12-week weight loss program held in the participating churches. Following completion of this program, one church will be assigned to be the intervention group, and the other church will be the comparison group. During Phase 2, participants in the intervention group will receive monthly telephone counseling plus access to the telehealth program, while the comparison group will only receive monthly telephone counseling. The specific aims of the study include: (1) to evaluate the effect of the telehealth program on change in body mass index; and (2) to evaluate the effect of the telehealth program on physical activity and fat, fiber, fruit and vegetable intake.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Self-identification as an African-American or Black woman
- Age 35-65 years
- Body mass index 25-50 kg/m2
- Physician approval to safely exercise if any positive answers on Physical Activity Readiness Questionnaire
- Owns a television
- Has a working telephone line
Exclusion Criteria:
- Plans to move from the Chicago area during the coming year
- Has a household member already in the study
- Uses illicit drugs or drinks more than two alcoholic drinks daily
- Pregnant, nursing, or planning pregnancy
- Participating in an organized weight loss program or using pharmacotherapy for weight loss
- Use an assistive device for ambulation, or cannot participate in exercise classes
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 |
|---|---|
|
Comparador activo: Telephone Support Only
These participants receive telephone support only during the weight maintenance phase.
|
An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants.
All participants attend the church programs prior to the weight maintenance phase.
Following completion of the weight loss program, participants will receive monthly telephone counseling.
|
|
Experimental: Telehealth
These participants receive telehealth support (with Internet-enabled digital video recorders) during the weight maintenance phase.
These participants also receive telephone support monthly.
|
An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants.
All participants attend the church programs prior to the weight maintenance phase.
Following completion of the weight loss program, participants will receive monthly telephone counseling.
After the weight loss program, women will access the home weight maintenance telehealth program through Internet enabled digital video recorders connected to their television sets.
The telehealth program includes three components: (1) Weekly Video: home access to weekly video programs including problem solving and relapse prevention strategies, as well as motivational stories; (2) Teleexercise: home access to updated video exercise programs; and (3) Electronic Communication: social support through online communication with other participants, and with an exercise and nutrition interventionist.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Índice de masa corporal
Periodo de tiempo: 12 meses
|
12 meses
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical activity
Periodo de tiempo: 12 months
|
12 months
|
|
|
Dietary intake
Periodo de tiempo: 12 months
|
Dietary intake includes fat, fiber, fruits and vegetables.
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ben Gerber, MD, MPH, University of Illinois at Chicago
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 2006-0836
- R21DK078352 (Subvención/contrato del NIH de EE. UU.)
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