VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities

Not Applicable

• Conditions: Pediatric Obesity
• Interventions: Behavioral: Vidas Activas, famiLias saludablEs (VALE)

• Registration Number: NCT04677582
• Lead Sponsor: George Mason University

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.

Study Timeline

• Study Start: 2017-10-04
• Study First Submitted: 2018-08-09
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-18
• Last Update Submitted: 2020-12-18
• Study First Posted: 2020-12-21
• Last Update Posted: 2020-12-21
• Primary Completion: 2021-06-20
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Vidas Activas, famiLias saludablEs (VALE)	The intervention group will receive weekly education sessions about nutrition, exercise, and behavioral health.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Featherstone Elementary School; 🇺🇸 Woodbridge, Virginia, United States

Kilby Elementary School; 🇺🇸 Woodbridge, Virginia, United States