- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02343367
Health4Kids Intervention Trial for Hispanic Families (H4K)
17 de diciembre de 2020 actualizado por: The University of Texas Health Science Center at San Antonio
Pediatric Obesity Management Intervention Trial for Hispanic Families
The H4K Trial is a randomized controlled trial to improve children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese Hispanic children (ages 6-11) in three pediatric clinics in San Antonio, Texas.
The H4K trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and text messages) compared to standard care (physician counseling only) on three outcomes: 1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and consumption of sugary beverages and fruits and vegetables.
The investigators will recruit 230 overweight and obese children-and a parent or guardian for each-and randomize them to the H4K intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads).
The investigators hypothesize that intervention children will significantly improve their body composition, increased their PA levels and diet quality (more fruits and vegetables and less sugary beverages), and decrease their sedentary activity, compared to children in standard care.
If successful, this study will generate new scientific knowledge about effective Hispanic family-based approaches for obesity prevention with high potential for replication in underserved areas across the nation.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Given the continuing rise of the U.S. Hispanic population, reversing the Hispanic childhood obesity epidemic is critical to the nation's future health.
Mexican American children and those from socioeconomically disadvantaged families often are far more overweight and obese than their peers, heightening their risk for obesity-related health complications.
Our proposed randomized controlled trial, the Health4Kids (H4K) Trial for Hispanic Families, aims to improve Hispanic children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese (body mass index (BMI) between the 85th and 99.9thth (<99th) percentile for age and gender) Hispanic children ages 6-11 in pediatric clinics in San Antonio, Texas, a largely Hispanic city.
Our team, formed during our pilot research funded by the Centers for Medicare and Medicaid Services (1H0CMS030457), unites academic investigators and community partners with experience working together to conduct behavioral and clinical interventions and outreach with Hispanics.
The H4K trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and text messages) compared to standard care (physician counseling only) on three outcomes: 1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and consumption of sugary beverages and fruits and vegetables.
We will recruit 230 overweight and obese children-and a parent or guardian for each-and randomize them to the POM intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads).
From a baseline, we will measure the impact of the trial on the primary outcome (body composition) and secondary outcomes (insulin, glucose and cholesterol levels and several specific health behavior changes) at 1 month, 6 and 12 months post-randomization.
We also will evaluate the critical role of parenting strategies and changes in the home environment as mediators of intervention effects.
We hypothesize that intervention children will significantly improve their body composition, increased their PA levels and diet quality (more fruits and vegetables and less sugary beverages), and decrease their sedentary activity, compared to children in standard care.
If successful, this study will generate new scientific knowledge about effective Hispanic family-based approaches for obesity prevention with high potential for replication in underserved areas across the nation.
Tipo de estudio
Intervencionista
Inscripción (Actual)
518
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
-
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center San Antonio
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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
6 años a 11 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
A child is eligible for the POM trial for meeting the following criteria:
- identified by parent or legal guardian as Hispanic
- age 6-11
- overweight or obese (BMI between the 85th and 99.9thth (<99th) percentile for age and gender
- one parent/guardian that the child resides with full-time must agree to participate in intervention and evaluation activities.
Exclusion Criteria:
A child will be excluded if he/she has:
- a mental, emotional, or physical handicap identified by parents or health care provider that may interfere with study participation
- a diagnosis of cardiovascular, pulmonary, or digestive disease
- parent without a cell phone
- parent unable or not willing to receive text messages
- child or parent planning to move from the local area within the time span of the study.
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Standard Care
Brief patient-centered behavioral counseling using the Healthy Lifestyle Prescription, health education materials and a community resource guide.
Follow-up visits scheduled at 1, 6, and 12 months.
Parent receives weekly general health education cell phone text messages for 12 months
|
Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription
Health education materials about healthy eating and physical activity and a community resource guide
regularly scheduled cell phone text messages for 12 months
Otros nombres:
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Experimental: Pediatric Obesity Management
All elements of standard care plus a family-based face to face counseling session with a health educator, telephone counseling, mailed newsletters and regularly scheduled cell phone text messages with tips and motivational messages for healthy eating and PA, as well as information on community events and resources.
|
Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription
Health education materials about healthy eating and physical activity and a community resource guide
regularly scheduled cell phone text messages for 12 months
Otros nombres:
30 minute face-to-face family-centered behavioral counseling session delivered by a health educator
14 telephone counseling sessions delivered by a health educator using motivational interviewing techniques.
Two sessions per month for the first two months followed by one session per month for 10 months
12 monthly newsletters mailed to participant homes
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in weight (kg)
Periodo de tiempo: 6 months
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Weight will be measured using a portable Tanita Body Composition Analyzer SC-331S following standard protocol.
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6 months
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Change from baseline in waist circumference (cm)
Periodo de tiempo: 6 months
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Waist circumference (minimum waist girth) will be measured to the nearest 0.1 cm using a Myotape tape measure at the midpoint between the right iliac crests and the lower ribs when the subject is standing erect with feet together
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6 months
|
Change from baseline in body mass index (BMI z score)
Periodo de tiempo: 6 months
|
BMI will be calculated as weight (kg)/height squared (m2).
Weight will be measured by bioelectrical impedance analysis (BIA) using the foot-to-foot pressure contact electrode BIA technique using a portable Tanita Body Composition Analyzer SC-331S following standard protocol.
Height will be measured to the nearest 0.1 inch using a SECA brand stadiometer.
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6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in fasting insulin (µIu/mL)
Periodo de tiempo: 6 months
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Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
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6 months
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Change from baseline in fasting glucose (mg/dL)
Periodo de tiempo: 6 months
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Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
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6 months
|
Change in cholesterol (lipid panel: fasting total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) from baseline (mg/dL)
Periodo de tiempo: 6 months
|
Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
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6 months
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Change from baseline in moderate-to-vigorous physical activity (minutes/week)
Periodo de tiempo: 6 months
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Minutes per week of MVPA is assessed using accelerometry.
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6 months
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Change from baseline in consumption of sugar-sweetened beverages (servings/week)
Periodo de tiempo: 6 months
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Sugar-sweetened beverage consumption is assessed using the Block Kids Food Screener (Last Week version).
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6 months
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Change from baseline in consumption of fruits and vegetables (servings/day)
Periodo de tiempo: 6 months
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Fruit and vegetable consumption is assessed using the Block Kids Food Screener (Last Week version).
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6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Deborah M Parra-Medina, PhD, UT Health San Antonio
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 enero de 2015
Finalización primaria (Actual)
19 de noviembre de 2019
Finalización del estudio (Actual)
31 de marzo de 2020
Fechas de registro del estudio
Enviado por primera vez
6 de enero de 2015
Primero enviado que cumplió con los criterios de control de calidad
21 de enero de 2015
Publicado por primera vez (Estimar)
22 de enero de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de diciembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
17 de diciembre de 2020
Última verificación
1 de diciembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSC20130465H
- R01HD075936 (Subvención/contrato del NIH de EE. UU.)
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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