Clinical trial NCT02817009: 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
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Behavioral Health Intervention
Randomized Control Trial
Family Intervention
Nutrition
Weight Management
Multidisciplinary Program
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 53
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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)

Primary outcomes:
measure: Stabilize Body Mass Index (BMI)
timeFrame: 3 months
Secondary outcomes:
measure: Differences in 5-2-1-0 measures between baseline and post-intervention session
timeFrame: 3 months
measure: Stabilize BMI z-score
timeFrame: 3 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Lutheran Medical Center
state: New York
Study officials:
affiliation: NYU Lutheran
name: Marisol Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References: