- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02343367
Health4Kids Intervention Trial for Hispanic Families (H4K)
17 grudnia 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
518
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Texas
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San Antonio, Texas, Stany Zjednoczone, 78229
- University of Texas Health Science Center San Antonio
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
6 lat do 11 lat (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: 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
Inne nazwy:
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Eksperymentalny: 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
Inne nazwy:
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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from baseline in weight (kg)
Ramy czasowe: 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)
Ramy czasowe: 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
|
6 months
|
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Change from baseline in body mass index (BMI z score)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from baseline in fasting insulin (µIu/mL)
Ramy czasowe: 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 fasting glucose (mg/dL)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 6 months
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Sugar-sweetened beverage consumption is assessed using the Block Kids Food Screener (Last Week version).
|
6 months
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Change from baseline in consumption of fruits and vegetables (servings/day)
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Deborah M Parra-Medina, PhD, UT Health San Antonio
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 stycznia 2015
Zakończenie podstawowe (Rzeczywisty)
19 listopada 2019
Ukończenie studiów (Rzeczywisty)
31 marca 2020
Daty rejestracji na studia
Pierwszy przesłany
6 stycznia 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 stycznia 2015
Pierwszy wysłany (Oszacować)
22 stycznia 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
21 grudnia 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 grudnia 2020
Ostatnia weryfikacja
1 grudnia 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HSC20130465H
- R01HD075936 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .