PACT PDParents and Children Together Preventing Diabetes
Lifestyle Intervention
+ Standard Family-Based intervention
Estudio de Prevención
Resumen
Fecha de inicio: 1 de marzo de 2013
Fecha en la que se inscribió al primer participante.The investigators' long-term research goal is to translate the Diabetes Prevention Program (DPP) in community-based settings for overweight/obese African American (AA) families at risk for Type 2 Diabetes Mellitus (T2DM). Intensive lifestyle approaches addressing physical activity, healthy eating patterns, and stress management are established methods for reducing obesity and risk of T2DM for adults (Knowler, 2002; Tuomilehto et al, 2001; Pan et al, 1997). But, minimal evidence exists that this knowledge has been translated in sustainable settings or in a manner that acknowledges the influences of daily life on motivation and family self-efficacy for changes in nutrition and physical activity. The study proposes to adapt these components for AA families through the use of "family coaches", one-on-one intervention sessions through supervised individualized physical activity, and tailoring intervention strategies for individual families. Utilizing a family systems approach, each component will be delivered using brief motivational strategies that will target self-efficacy and motivational readiness. This four month, two-arm randomized clinical trial, Parents and Children Together Preventing Diabetes (PACT PD) will test the central hypothesis that, relative to a control condition, a "family health coaching" intervention focused on nutrition and physical activity using brief motivational strategies will improve targeted dietary and physical activity behaviors in overweight/obese AA parents and their overweight/obese 8-10 year old children, (N=50 families) all of whom are at risk for T2DM diabetes. This study will test the feasibility and acceptability of training YMCA fitness staff to utilize brief motivational interviewing and serve as "family health coaches". This study will evaluate the early efficacy of the newly translated, family-based diabetes prevention intervention in improving anthropometric measures of BMI (primary outcome) and waist circumference, physical activity and dietary intake, and family functioning (secondary outcomes) and intervention fidelity, feasibility and acceptability of participants. Further, the study will assess the acceptability and feasibility of booster interventions for motivation maintenance and potential for long-term retention and intervention success in the subsequent R18 application. This study will provide critical information regarding the early effectiveness of an innovative, family-based, behavioral intervention for the prevention of T2DM specifically translated for AA families. This study is funded by the National Institutes for Diabetes and Digestive and Kidney Disorders.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 33 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 8 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Wake Forest Baptist Health
Winston-Salem, United StatesAbrir Wake Forest Baptist Health en Google Maps