Pediatric Obesity Clinical Trial
— VALÉOfficial title:
Vidas Activas, famiLias saludablEs (Active Lives, Healthy Families) (VALÉ)
Verified date | December 2020 |
Source | George Mason University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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:
Status | Active, not recruiting |
Enrollment | 140 |
Est. completion date | July 2021 |
Est. primary completion date | June 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 11 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Featherstone Elementary School | Woodbridge | Virginia |
United States | Kilby Elementary School | Woodbridge | Virginia |
Lead Sponsor | Collaborator |
---|---|
George Mason University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline BMI at 3 months and 6 months | body weight (kg)/height(m^2) | Baseline, 3 and 6 months | |
Primary | Change from Baseline Body Fat Percentage at 3 months and 6 months | % via bioelectric impedance | Baseline, 3 and 6 months | |
Primary | Change from Baseline Blood Pressure at 3 months and 6 months | Systolic & Diastolic Blood Pressure | Baseline, 3 and 6 months | |
Primary | Change from Baseline Waist Circumference at 3 months and 6 months | cm | Baseline, 3 and 6 months | |
Primary | Change from Baseline HbA1c at 3 months and 6 months | HbA1c (%) | Baseline, 3 and 6 months | |
Primary | Change from Baseline Glucose at 3 months and 6 months | Glucose (mg/dL) | Baseline, 3 and 6 months | |
Primary | Change from Baseline Blood Lipids at 3 months and 6 months | LDL, HDL, TRG, TC (mg/dL) | Baseline, 3 and 6 months |
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