An interventional study of Vidas Activas, famiLias saludablEs (VALE) in Pediatric Obesity, sponsored by George Mason University. Status unknown at 2 sites in United States. Open to participants aged 5 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by George Mason University · Not applicable, Interventional, and Treatment
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:
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 140 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →George Mason University is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention group will receive weekly education sessions about nutrition, exercise, and behavioral health.
Behavioral: Vidas Activas, famiLias saludablEs (VALE)
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.
Change from Baseline BMI at 3 months and 6 months
body weight (kg)/height(m\^2)
Time frame: Baseline, 3 and 6 months
Change from Baseline Body Fat Percentage at 3 months and 6 months
% via bioelectric impedance
Time frame: Baseline, 3 and 6 months
Change from Baseline Blood Pressure at 3 months and 6 months
Systolic \& Diastolic Blood Pressure
Time frame: Baseline, 3 and 6 months
Change from Baseline Waist Circumference at 3 months and 6 months
cm
Time frame: Baseline, 3 and 6 months
Change from Baseline HbA1c at 3 months and 6 months
HbA1c (%)
Time frame: Baseline, 3 and 6 months
Change from Baseline Glucose at 3 months and 6 months
Glucose (mg/dL)
Time frame: Baseline, 3 and 6 months
Change from Baseline Blood Lipids at 3 months and 6 months
LDL, HDL, TRG, TC (mg/dL)
Time frame: Baseline, 3 and 6 months
Plan to share: No
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This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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