Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers
20 september 2016 bijgewerkt door: NYU Langone Health
Childhood obesity is a contributing factor to health complications such as diabetes, heart disease, high blood pressure, cancer and asthma.
It is of particular concern among Hispanic populations in the United States as that group has the fastest growing childhood obesity rate.
Nearly two in five Hispanic children ages 2 to 19 are overweight or obese.
This program aims to test whether it is beneficial to routinize a multi-disciplinary pediatric weight management program within the highest volume clinic (NYU-LFHC Women, Adolescents and Children), and to add a home-visit component to reinforce teaching on food selection and preparation.
The intervention will include 27-hour intervention session which will be distributed into 12-session series over a 3 month period.
The program will target Hispanic children between the ages of 9 and 11 with a Body Mass Index (BMI) between the 95th and 99th percentiles.
To assess the effectiveness of this program, the investigators propose to conduct a general prospective study using randomized pre-test and post-test control group design with minimal risk for participants.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The proposed intervention will engage pediatricians at NYU Lutheran Family Health Centers (NYU LFHC) and providers at the school-based clinics in referring Hispanic children ages 9-11 years with a BMI between the 95th and 99th percentile to the study. In addition, a list will be generated from NYU Lutheran's Quality Improvement department if recruitment through providers is low. Providers will refer patients who meet the above criteria through eClincialWorks (ECW). A research assistant will then randomize the referrals after acquiring informed consent forms to either the control group or the intervention group. The control group will receive standard of care by nutritionists at NYU LFHC. The intervention group will receive a 27-hour intervention session which will be split into a 12-session series. The sessions will be conducted weekly over a 3 month period. This study will include three cycles with three separate cohorts.
The Healthy Families Intervention Group will include:
- Bilingual English and Spanish group nutrition education, behavioral social support, and physical activity (e.g. kickboxing, Zumba, yoga, aerobics).
- Monthly home visits by a nutritionist for family including specific recommendations on food purchasing and preparation.
Children randomized to standard of care will attend monthly sessions with a nutritionist.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
53
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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New York
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Brooklyn, New York, Verenigde Staten, 11220
- NYU Lutheran Medical Center
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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
9 jaar tot 11 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Patient of NYU-LFHC Women's, Pediatric, and Adolescent Medicine (5610)
- Hispanic ethnicity
- BMI percentile between the 95th and 99th
- Ages between 9 and 11 years old at the time the program begins
Exclusion Criteria:
- Autism Spectrum Disorder (299.0)
- Pervasive Developmental Disorder-Not Otherwise Specified (PDD NOS 299.9) and
- Other PDD (299.8)
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: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Nutrition Group
This group will go through standard of care and visit the nutritionist on a monthly basis for the three months that they are a part of the study.
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Experimenteel: Healthy Families Group
Participants and their families will attend a weekly nutrition session, social support session and physical activity session for 12 weeks.
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The social worker for the parent support group addresses culturally specific questions and adopts culturally acceptable strategies for setting limits and promoting healthy behaviors, engaging the group as a whole and building peer support.
Nutrition sessions will focus on how to make traditional Latin American foods healthier, including the sharing of recipes and learning what foods to buy in local supermarkets.
Home visits by the nutritionist assists with family-centric strategies for healthier eating in their urban Latino households, including those with large extended families.
45 minutes physical activity session to promote healthy behaviors
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Stabilize Body Mass Index (BMI)
Tijdsspanne: 3 months
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The goal is to stabilize or reduce the participant's BMI at the end of the study.
The height and weight of the control group will be measured at baseline and at the end of 3 months.
The height and weight of the intervention group will be measured at over 12 sessions within the 3 month time frame.
The intervention will be 27 hours in total.
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Differences in 5-2-1-0 measures between baseline and post-intervention session
Tijdsspanne: 3 months
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Compare pre-intervention and post-intervention data within the control and intervention group for cases for the following behaviors: physical activity, consumption of fruit and vegetables, sugar-sweetened beverages, and daily screen time (watching TV/YouTube, playing video games, using tablet/phone/mobile device), which will be collected through the 5-2-1-0 validated survey.
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3 months
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Stabilize BMI z-score
Tijdsspanne: 3 months
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The goal is to stabilize BMI z-score by the end of 3 months.
The BMI z-score will be calculated using the BMI collected in the primary outcome measure.
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3 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Marisol Gonzalez, MD, NYU Lutheran
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 december 2015
Primaire voltooiing (Werkelijk)
1 augustus 2016
Studie voltooiing (Werkelijk)
1 augustus 2016
Studieregistratiedata
Eerst ingediend
7 maart 2016
Eerst ingediend dat voldeed aan de QC-criteria
28 juni 2016
Eerst geplaatst (Schatting)
29 juni 2016
Updates van studierecords
Laatste update geplaatst (Schatting)
21 september 2016
Laatste update ingediend die voldeed aan QC-criteria
20 september 2016
Laatst geverifieerd
1 september 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 16-00319
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
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