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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817009
• Other study ID #: 16-00319
• Status: Completed
• Phase: N/A
• First received: March 7, 2016
• Last updated: September 20, 2016
• Start date: December 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

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.
• 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.
• Physical Activity Session
45 minutes physical activity session to promote healthy behaviors

Locations

Country	Name	City	State
United States	NYU Lutheran Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No