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

NCT02817009 | Completed

• 1 other identifier: 16-00319
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Behavioral Health Intervention; Randomized Control Trial; Family Intervention; Nutrition; Weight Management; Multidisciplinary Program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Differences in 5-2-1-0 measures between baseline and post-intervention session

  3 months

• Stabilize BMI z-score

  3 months

Study Arms (2)

Nutrition Group

NO INTERVENTION

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.

Healthy Families Group

EXPERIMENTAL

Participants and their families will attend a weekly nutrition session, social support session and physical activity session for 12 weeks.

Behavioral: Social Support; Behavioral: Nutrition Session; Behavioral: Physical Activity Session

Interventions

Social Support BEHAVIORAL

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.

Healthy Families Group

Nutrition Session BEHAVIORAL

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.

Healthy Families Group

Physical Activity Session BEHAVIORAL

45 minutes physical activity session to promote healthy behaviors

Healthy Families Group

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Autism Spectrum Disorder (299.0)
• Pervasive Developmental Disorder-Not Otherwise Specified (PDD NOS 299.9) and
• Other PDD (299.8)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Lutheran Medical Center

Brooklyn, New York, 11220, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marisol Gonzalez, MD

  NYU Lutheran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: June 29, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)