Completado

PACT PDParents and Children Together Preventing Diabetes

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Lifestyle Intervention

+ Standard Family-Based intervention

Conductual
Quiénes están siendo reclutados

A partir de 8 años
+11 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: marzo de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalWake Forest University Health Sciences
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

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.

Título OficialParents and Children Together Preventing Diabetes
NCT01819493
Patrocinador PrincipalWake Forest University Health Sciences
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 33 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

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

3 criterios de inclusión requeridos para participar
Body Mass index (One overweight/obese parent (25 kg/m2 <BMI<40 kg/m2 and one overweight/obese child (at or above the 85th% of age-and gender- specific BMI)

Parental HbA1c levels (pre-diabetes = 5.7 - 6.4%)

Parent and their child age 8-10

8 criterios de exclusión impiden participar
Clinical history of T2DM

On glucose-lowering drugs

Currently participating in a supervised weight loss program

Pregnant or Breastfeeding

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
The lifestyle intervention for adults will involve a dietary weight loss program and an increase in caloric expenditure through moderate PA. Parents will be encouraged to decrease caloric intake in a sound manner to produce a total weight loss of 5%. The PA component will be to promote an increase in family home-based activity. Children. The study will promote healthy eating behaviors, rather than restrictive eating plans with caloric restrictions.

Grupo II

Comparador Activo
Families randomized to the Standard Family-based Intervention will receive three-month family YMCA memberships, one orientation training session, access to available equipment and programming at the YMCA, and receive diabetes educational materials from the "Power to Prevent" curriculum via email. Based on our previous experience with AA adults, the investigators anticipate that all families will have access to email either at home or at work. Educational materials will be mailed to families without access to email. The study will also maintain contact with participants by sending holiday and birthday cards, as well as postcard reminders of scheduled data collection visits.

Objetivos 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

Suspendido

Wake Forest Baptist Health

Winston-Salem, United StatesAbrir Wake Forest Baptist Health en Google Maps
Completado1 Centros de Estudio