NCT02817009

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Childhood Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-06-29
• Last updated: 2016-09-21

Locations

1 site across 1 country: United States