VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities

Study Overview
=================
Brief Summary
-----------------
This proposal aims to test the initial feasibility and efficacy of a 10-week multidisciplinary pediatric weight management program among low-income Latino children, aged 5 to 11 years, from the Woodbridge, VA area. The following specific aims will be tested:

Detailed Description
-----------------
Specific Aim 1: To test the acceptability of a multidisciplinary group intervention targeted towards low-income Latino families with a child who is obese. Specific Aim 2: To test the effectiveness of the intervention by determining differences in behavioral changes (i.e. nutrition and physical activity habits), anthropometric (BMI-for-age, body fat) and clinical health outcomes (i.e. blood pressure, blood biomarkers) between children exposed to the intervention program vs. control children.

Official Title
-----------------
Vidas Activas, famiLias saludablEs (Active Lives, Healthy Families) (VALÉ)

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Behavioral: Vidas Activas, famiLias saludablEs (VALE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-pubertal (girls must not have started menses) Of Latino/Hispanic descent (parent self-identified) BMI for age >85th percentile (based on CDC growth reference) Child between 5-11 years old Healthy (no known chronic diseases or regular medication) Parent/adult caregivers willing to participate in all study visits Exclusion Criteria: Not of Latino/Hispanic descent <5 years old or >11 years old BMI for age <85th percentile Not pre-pubertal (girls have experienced their first menses) Child has learning deficits or acute/chronic medical condition Parent/guardian has no transportation or unable to participate in sessions

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The intervention group will receive weekly education sessions about nutrition, exercise, and behavioral health. | Behavioral: Vidas Activas, famiLias saludablEs (VALE)<br>* Families and Children allocated to the intervention will receive weekly group-based meetings over a 10-week period consisting of education and activities on healthy lifestyles. Graduate students/Research Assistants trained in nutrition, exercise and clinical psychology will lead the meetings. All activities will be culturally relevant (i.e. cooking healthy Latino recipes) and Spanish speaking students will be recruited to deliver the intervention. Participants will be involved on deciding activities and projects and while some sessions will meet as a family group with parents/guardians, others will meet separately.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline BMI at 3 months and 6 months | body weight (kg)/height(m^2) | Baseline, 3 and 6 months | 
| Change from Baseline Body Fat Percentage at 3 months and 6 months | % via bioelectric impedance | Baseline, 3 and 6 months | 
| Change from Baseline Blood Pressure at 3 months and 6 months | Systolic & Diastolic Blood Pressure | Baseline, 3 and 6 months | 
| Change from Baseline Waist Circumference at 3 months and 6 months | cm | Baseline, 3 and 6 months | 
| Change from Baseline HbA1c at 3 months and 6 months | HbA1c (%) | Baseline, 3 and 6 months | 
| Change from Baseline Glucose at 3 months and 6 months | Glucose (mg/dL) | Baseline, 3 and 6 months | 
| Change from Baseline Blood Lipids at 3 months and 6 months | LDL, HDL, TRG, TC (mg/dL) | Baseline, 3 and 6 months |