Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 9 - 11 |
| Updated: | 6/30/2016 |
| Start Date: | December 2015 |
| End Date: | August 2016 |
| Contact: | Marisol Gonzalez, MD |
| Email: | Marisol.Gonzalez@nyumc.org |
| Phone: | 917-817-5842 |
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.
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.
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.
(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.
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)
We found this trial at
1
site
Brooklyn, New York 11220
Principal Investigator: Marisol Gonzalez, MD, MPH
Phone: 917-817-5842
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