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Health4Kids Intervention Trial for Hispanic Families (H4K)
17 december 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
518
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Texas
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San Antonio, Texas, Verenigde Staten, 78229
- University of Texas Health Science Center San Antonio
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 jaar tot 11 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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
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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
Andere namen:
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Experimenteel: 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.
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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
Andere namen:
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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in weight (kg)
Tijdsspanne: 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)
Tijdsspanne: 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
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Change from baseline in body mass index (BMI z score)
Tijdsspanne: 6 months
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in fasting insulin (µIu/mL)
Tijdsspanne: 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)
Tijdsspanne: 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 in cholesterol (lipid panel: fasting total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) from baseline (mg/dL)
Tijdsspanne: 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 moderate-to-vigorous physical activity (minutes/week)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Deborah M Parra-Medina, PhD, UT Health San Antonio
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2015
Primaire voltooiing (Werkelijk)
19 november 2019
Studie voltooiing (Werkelijk)
31 maart 2020
Studieregistratiedata
Eerst ingediend
6 januari 2015
Eerst ingediend dat voldeed aan de QC-criteria
21 januari 2015
Eerst geplaatst (Schatting)
22 januari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 december 2020
Laatste update ingediend die voldeed aan QC-criteria
17 december 2020
Laatst geverifieerd
1 december 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HSC20130465H
- R01HD075936 (Subsidie/contract van de Amerikaanse NIH)
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