- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02938312
Journey to Better Health (JTBH)
Deep South Network for Cancer Control - Healthier Weight Among African American Women
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Using a cluster-randomized study design, 400 overweight or obese African American women living in 8 rural counties in Alabama and Mississippi associated with the Deep South Network for Cancer Control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years.
Weight Loss Only condition: In year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. In year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. In-person group meetings will be facilitated by a trained lay staff and community health advisors. Monthly phone calls will be conducted by the community health advisor.
Weight Loss Plus Community Strategies condition: Participants will receive the same weight loss program as the Weight Loss Only condition. In addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails).
Over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate BMI), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- African American female
- Live or work in target county
- BMI >= 25 kg/m2
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next year
- Known major medical or psychological condition known to influence body weight
- Uncontrolled hypertension (BP > 160 mmHg systolic or >100 mmHg diastolic)
- Cardiovascular event in the preceding 12 months
- History of gastric bypass surgery
- History of psychiatric hospitalization in past 2 years
- History of substance abuse or eating disorder
- Any other condition by which a medical professional has suggested diet modification
- Physical activity and/or weight reduction would be contraindicated
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Weight Loss Only
24- month weight loss program (year 1: weekly in-person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls)
|
Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months.
Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week.
During 1-year weight loss maintenance, participants receive monthly motivational phone calls.
|
Experimental: Weight Loss Plus
Same intervention as "Weight Loss Only" but includes community-wide interventions to increase access to healthy affordable food and opportunities for safe and convenient physical activity
|
Participants attend in-person meetings as described above.
This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Weight
Periodo de tiempo: baseline to 6-months
|
Measured weight (nearest kg)
|
baseline to 6-months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Waist Circumference
Periodo de tiempo: baseline to 6-months
|
Measured circumference (nearest cm)
|
baseline to 6-months
|
Blood Pressure
Periodo de tiempo: baseline to 6-months
|
Measured blood pressure (mmHG) - systolic and diastolic
|
baseline to 6-months
|
Lipids
Periodo de tiempo: baseline to 6-months
|
Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
|
baseline to 6-months
|
Weight
Periodo de tiempo: baseline to 12-months
|
Measured weight (nearest kg)
|
baseline to 12-months
|
Weight
Periodo de tiempo: baseline to 24-months
|
Measured weight (nearest kg)
|
baseline to 24-months
|
Social Support for Healthy Eating and Exercise
Periodo de tiempo: baseline to 6-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
|
baseline to 6-months
|
Social Support for Healthy Eating and Exercise
Periodo de tiempo: baseline to 12-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
|
baseline to 12-months
|
Social Support Healthy Eating and Exercise
Periodo de tiempo: baseline to 24-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
|
baseline to 24-months
|
Self Efficacy for Healthy Eating and Exercise
Periodo de tiempo: baseline to 6-months
|
Self-report questionnaire about confidence in ability to eat healthy and exercise.
Composite and subscale scores are calculated.
|
baseline to 6-months
|
Self Efficacy for Healthy Eating and Exercise
Periodo de tiempo: baseline to 12-months
|
Self-report
|
baseline to 12-months
|
Self Efficacy for Healthy Eating and Exercise
Periodo de tiempo: baseline to 24-months
|
Self-report questionnaire about confidence in ability to eat healthy and exercise.
Composite and subscale scores are calculated.
|
baseline to 24-months
|
Dietary Intake
Periodo de tiempo: baseline to 6-months
|
24 hour recall
|
baseline to 6-months
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Dietary Intake
Periodo de tiempo: baseline to 12-months
|
24 hour recall
|
baseline to 12-months
|
Dietary Intake
Periodo de tiempo: baseline to 24-months
|
24 hour recall
|
baseline to 24-months
|
Perceived Stress Scale
Periodo de tiempo: baseline to 6-months
|
Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
|
baseline to 6-months
|
Perceived Stress Scale
Periodo de tiempo: baseline to 12-months
|
Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
|
baseline to 12-months
|
Perceived Stress Scale
Periodo de tiempo: baseline to 24-months
|
Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
|
baseline to 24-months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- F100708003
- 1U54CA153719 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
Ensayos clínicos sobre Weight Loss Only
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-
The Miriam HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Aún no reclutando
-
University of North Carolina, Chapel HillWeight Watchers InternationalTerminadoSobrepeso y ObesidadEstados Unidos
-
University Hospital, GhentTerminado
-
University of PennsylvaniaWeight Watchers InternationalTerminado
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University of RochesterActivo, no reclutandoObesidad | Exceso de peso | Estilo de vida saludable | Riesgos cardiovasculares | Investigación de implementaciónEstados Unidos
-
The Miriam HospitalUniversity of Tennessee; Weight Watchers InternationalTerminado
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University of North Carolina, Chapel HillWeight Watchers InternationalTerminadoObesidad | Pérdida de peso | Modificación de la dieta | Cambio de Peso, CuerpoEstados Unidos, Canadá, Reino Unido
-
Medical University of South CarolinaWeight Watchers InternationalTerminadoObesidad | Exceso de peso | Diabetes tipo 2Estados Unidos
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The Miriam HospitalUniversity of Tennessee; Weight Watchers InternationalTerminadoObesidad | Exceso de peso | Peso corporalEstados Unidos