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Health4Kids Intervention Trial for Hispanic Families (H4K)

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

518

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Texas
      • San Antonio, Texas, États-Unis, 78229
        • University of Texas Health Science Center San Antonio

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

6 ans à 11 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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
Autres noms:
  • SMS
Expérimental: 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
Autres noms:
  • 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in weight (kg)
Délai: 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)
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in fasting insulin (µIu/mL)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 6 months
Minutes per week of MVPA is assessed using accelerometry.
6 months
Change from baseline in consumption of sugar-sweetened beverages (servings/week)
Délai: 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)
Délai: 6 months
Fruit and vegetable consumption is assessed using the Block Kids Food Screener (Last Week version).
6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2015

Achèvement primaire (Réel)

19 novembre 2019

Achèvement de l'étude (Réel)

31 mars 2020

Dates d'inscription aux études

Première soumission

6 janvier 2015

Première soumission répondant aux critères de contrôle qualité

21 janvier 2015

Première publication (Estimation)

22 janvier 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 décembre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 décembre 2020

Dernière vérification

1 décembre 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • HSC20130465H
  • R01HD075936 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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