VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities (VALÉ)

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

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:

Study Overview

• Status: Unknown
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: Vidas Activas, famiLias saludablEs (VALE)

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Woodbridge, Virginia, United States, 22191
      • Featherstone Elementary School
    • Woodbridge, Virginia, United States, 22191
      • Kilby Elementary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Group; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: George Mason University
• Investigators: Principal Investigator: Margaret Jones, PhD, CSCS*D, George Mason University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2017
• Primary Completion (Anticipated): June 20, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 117702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No