Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Social Support; Nutrition Session; Physical Activity Session
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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 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.; 45 minutes physical activity session to promote healthy behaviors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral Health Intervention; Randomized Control Trial; Family Intervention; Nutrition; Weight Management; Multidisciplinary Program