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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Social Support; Behavioral: Nutrition Session; Behavioral: Physical Activity Session

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:

1. Bilingual English and Spanish group nutrition education, behavioral social support, and physical activity (e.g. kickboxing, Zumba, yoga, aerobics).
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11220
      • NYU Lutheran Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: Healthy Families Group; Participants and their families will attend a weekly nutrition session, social support session and physical activity session for 12 weeks.	Behavioral: Social Support; 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.; Behavioral: Nutrition Session; 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.; Behavioral: Physical Activity Session; 45 minutes physical activity session to promote healthy behaviors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	3 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Marisol Gonzalez, MD, NYU Lutheran

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Nutrition; Family Intervention; Randomized Control Trial; Behavioral Health Intervention; Weight Management; Multidisciplinary Program
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 16-00319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No