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Journey to Better Health (JTBH)

21 de octubre de 2016 actualizado por: Monica L Baskin, University of Alabama at Birmingham

Deep South Network for Cancer Control - Healthier Weight Among African American Women

This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.

Descripción general del estudio

Estado

Terminado

Condiciones

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

Intervencionista

Inscripción (Actual)

409

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
        • University of Alabama at Birmingham

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

30 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2010

Finalización primaria (Actual)

1 de abril de 2015

Finalización del estudio (Actual)

1 de agosto de 2015

Fechas de registro del estudio

Enviado por primera vez

17 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

18 de octubre de 2016

Publicado por primera vez (Estimar)

19 de octubre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de octubre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

21 de octubre de 2016

Última verificación

1 de octubre de 2016

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)?

NO

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. .

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