Vidas Activas, famiLias saludablEs (Active Lives, Healthy Families) (VALÉ)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric Obesity
- Sponsor
- George Mason University
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Change from Baseline Blood Pressure at 3 months and 6 months
- Last Updated
- 5 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Change from Baseline Blood Pressure at 3 months and 6 months
Time Frame: Baseline, 3 and 6 months
Systolic \& Diastolic Blood Pressure
Change from Baseline BMI at 3 months and 6 months
Time Frame: Baseline, 3 and 6 months
body weight (kg)/height(m\^2)
Change from Baseline HbA1c at 3 months and 6 months
Time Frame: Baseline, 3 and 6 months
HbA1c (%)
Change from Baseline Body Fat Percentage at 3 months and 6 months
Time Frame: Baseline, 3 and 6 months
% via bioelectric impedance
Change from Baseline Blood Lipids at 3 months and 6 months
Time Frame: Baseline, 3 and 6 months
LDL, HDL, TRG, TC (mg/dL)
Change from Baseline Waist Circumference at 3 months and 6 months
Time Frame: Baseline, 3 and 6 months
cm
Change from Baseline Glucose at 3 months and 6 months
Time Frame: Baseline, 3 and 6 months
Glucose (mg/dL)