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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

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

    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
        • University of Texas Health Science Center San Antonio

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:
  • SMS
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:
  • SMS
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

¿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
Weight will be measured using a portable Tanita Body Composition Analyzer SC-331S following standard protocol.
6 months
Change from baseline in waist circumference (cm)
Periodo de tiempo: 6 months
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
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.
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
Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
6 months
Change from baseline in fasting glucose (mg/dL)
Periodo de tiempo: 6 months
Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
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.
6 months
Change from baseline in moderate-to-vigorous physical activity (minutes/week)
Periodo de tiempo: 6 months
Minutes per week of MVPA is assessed using accelerometry.
6 months
Change from baseline in consumption of sugar-sweetened beverages (servings/week)
Periodo de tiempo: 6 months
Sugar-sweetened beverage consumption is assessed using the Block Kids Food Screener (Last Week version).
6 months
Change from baseline in consumption of fruits and vegetables (servings/day)
Periodo de tiempo: 6 months
Fruit and vegetable consumption is assessed using the Block Kids Food Screener (Last Week version).
6 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 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

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. .

Ensayos clínicos sobre behavioral counseling

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