Reducing Obesity in Underserved Postpartum African American Women (RENEW)
27 de junio de 2017 actualizado por: Caroline Apovian, Boston Medical Center
In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based weight loss program to reduce obesity among postpartum African American (AA) adult women that can be integrated into a postpartum care model within a clinical setting.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators proposal adapts The Diabetes Prevention Program (DPP) 16 session core curriculum to our 8 session model and in addition uses the cultural tailoring techniques of the DPP to address the needs of our AA population in several ways: 1) The reference materials and lesson handouts include information about the types of foods and cooking methods used by an AA culture (see Other Study Documents); 2) Topics are selected for group classes that are most appropriate for our participants such as Hip Hop or Salsa dancing for physical activity.
Participants will be randomized during the early postpartum period to either usual care or intervention. Usual care participants will be offered the weight management standard of care which is one visit with a dietitian in the Nutrition and Weight Management Center. Intervention participants will be assigned a Birth Sister for the postpartum period. They will also attend 8 weekly sessions for the weight loss program. All participants will complete study assessment visits at 6 weeks postpartum and 15 weeks postpartum.
Tipo de estudio
Intervencionista
Inscripción (Actual)
128
Fase
- No aplica
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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
Pre-Natal:
- BMI greater than or equal to 25
- Ready to change (classified as answering yes to: Are you seriously considering trying to lose weight to reach your goal in the next 6 months?)
- English-speaking
Post-partum:
- Live birth (based on medical record review)
Exclusion Criteria:
Pre-Natal:
- Signs of moderate to severe depression based on the Patient Health Questionnaire-9 (PHQ-9)
- Previous enrollment in the Birth Sister's program prior to the study
Post-partum:
- Signs of moderate to severe post-partum depression based on the Edinburgh Postnatal Depression Scale (EPDS)
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
Weekly, in-person, support groups providing nutrition and physical activity education
|
Eight weekly in-person groups
|
|
Sin intervención: Control
Standard of care - one counseling visit with a study dietitian
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Periodo de tiempo: Weekly up to 8 weeks
|
Weekly up to 8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline Weight to 8 Weeks
Periodo de tiempo: Baseline and 8 weeks
|
Baseline and 8 weeks
|
|
|
Participant Satisfaction as Measured by Questionnaire and Exit Interview
Periodo de tiempo: 8 weeks
|
8 weeks
|
|
|
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire
Periodo de tiempo: Baseline and 8 weeks
|
Items were rated on a 5 point scale (1 strongly disagree, 2 disagree, 3 neutral or not applicable, 4 agree, 5 strongly agree).
We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree).
What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score).
|
Baseline and 8 weeks
|
|
Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire
Periodo de tiempo: Baseline and 8 weeks
|
The Multidimensional Body Relations Questionnaire (MBSRQ-AS) includes the following subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale (BASS).
We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree).
What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score).
Scale ranges from 1-5 (1=definitely disagree, 2=mostly disagree, 3=neither agree nor disagree, 4=mostly agree, 5=definitely agree) with higher scores reflecting better outcome.
A positive value shows improvement in that subscale over time.
|
Baseline and 8 weeks
|
|
Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale
Periodo de tiempo: Baseline and 8 weeks
|
Activity indices were created for each domain of activity (household/caregiving, occupational, active living, sports/exercise) by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree).
What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at Baseline from that measured at 8 weeks (difference = 8 weeks score - baseline score).
|
Baseline and 8 weeks
|
|
Waist Circumference at 8 Weeks
Periodo de tiempo: 8 weeks
|
8 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Caroline M. Apovian, MD, Professor of Medicine and Pediatrics
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 2011
Finalización primaria (Actual)
1 de septiembre de 2013
Finalización del estudio (Actual)
1 de septiembre de 2013
Fechas de registro del estudio
Enviado por primera vez
12 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2015
Publicado por primera vez (Estimar)
19 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de agosto de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
27 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-28272
- R21HD061311 (Subvención/contrato del NIH de EE. UU.)
- U54TR001012 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
Ensayos clínicos sobre Nutrition and physical activity education
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University of Texas Southwestern Medical CenterAmerican Heart AssociationAún no reclutandoInsuficiencia Cardíaca Sistólica