Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers
20 september 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
53
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New York
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Brooklyn, New York, Förenta staterna, 11220
- NYU Lutheran Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
9 år till 11 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Stabilize Body Mass Index (BMI)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Differences in 5-2-1-0 measures between baseline and post-intervention session
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Marisol Gonzalez, MD, NYU Lutheran
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2015
Primärt slutförande (Faktisk)
1 augusti 2016
Avslutad studie (Faktisk)
1 augusti 2016
Studieregistreringsdatum
Först inskickad
7 mars 2016
Först inskickad som uppfyllde QC-kriterierna
28 juni 2016
Första postat (Uppskatta)
29 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 september 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 september 2016
Senast verifierad
1 september 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16-00319
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .