VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities

Pediatric Obesity Clinical Trial

— VALÉ  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04677582
• Other study ID #: 117702
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2017
• Est. completion date: July 2021

Study information

• Verified date: December 2020
• Source: George Mason University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Featherstone Elementary School	Woodbridge	Virginia
United States	Kilby Elementary School	Woodbridge	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
George Mason University

Country where clinical trial is conducted

United States, 

Outcome

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