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Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Support
Nutrition Session
Physical Activity Session
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Behavioral Health Intervention, Randomized Control Trial, Family Intervention, Nutrition, Weight Management, Multidisciplinary Program

Eligibility Criteria

9 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • NYU Lutheran Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Nutrition Group

Healthy Families Group

Arm Description

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.

Participants and their families will attend a weekly nutrition session, social support session and physical activity session for 12 weeks.

Outcomes

Primary Outcome Measures

Stabilize Body Mass Index (BMI)
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.

Secondary Outcome Measures

Differences in 5-2-1-0 measures between baseline and post-intervention session
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.
Stabilize BMI z-score
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.

Full Information

First Posted
March 7, 2016
Last Updated
September 20, 2016
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02817009
Brief Title
Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers
Official Title
Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Behavioral Health Intervention, Randomized Control Trial, Family Intervention, Nutrition, Weight Management, Multidisciplinary Program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Healthy Families Group
Arm Type
Experimental
Arm Description
Participants and their families will attend a weekly nutrition session, social support session and physical activity session for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Social Support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Session
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Session
Intervention Description
45 minutes physical activity session to promote healthy behaviors
Primary Outcome Measure Information:
Title
Stabilize Body Mass Index (BMI)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Differences in 5-2-1-0 measures between baseline and post-intervention session
Description
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.
Time Frame
3 months
Title
Stabilize BMI z-score
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisol Gonzalez, MD
Organizational Affiliation
NYU Lutheran
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Lutheran Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers

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