VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities

George Mason University (GMU)

Status: Unknown

Conditions: Pediatric Obesity

Treatments: Behavioral: Vidas Activas, famiLias saludablEs (VALE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04677582

117702

Details and patient eligibility

About

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:

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 5 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Intervention Group

Experimental group

Description:

The intervention group will receive weekly education sessions about nutrition, exercise, and behavioral health.

Treatment:

Behavioral: Vidas Activas, famiLias saludablEs (VALE)