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

Primary Purpose

Pediatric Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vidas Activas, famiLias saludablEs (VALE)
Sponsored by
George Mason University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

5 Years - 11 Years (Child)All SexesAccepts 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

Sites / Locations

  • Featherstone Elementary School
  • Kilby Elementary School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 9, 2018
Last Updated
December 18, 2020
Sponsor
George Mason University
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1. Study Identification

Unique Protocol Identification Number
NCT04677582
Brief Title
VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities
Acronym
VALÉ
Official Title
Vidas Activas, famiLias saludablEs (Active Lives, Healthy Families) (VALÉ)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
June 20, 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Mason University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will receive weekly education sessions about nutrition, exercise, and behavioral health.
Intervention Type
Behavioral
Intervention Name(s)
Vidas Activas, famiLias saludablEs (VALE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline BMI at 3 months and 6 months
Description
body weight (kg)/height(m^2)
Time Frame
Baseline, 3 and 6 months
Title
Change from Baseline Body Fat Percentage at 3 months and 6 months
Description
% via bioelectric impedance
Time Frame
Baseline, 3 and 6 months
Title
Change from Baseline Blood Pressure at 3 months and 6 months
Description
Systolic & Diastolic Blood Pressure
Time Frame
Baseline, 3 and 6 months
Title
Change from Baseline Waist Circumference at 3 months and 6 months
Description
cm
Time Frame
Baseline, 3 and 6 months
Title
Change from Baseline HbA1c at 3 months and 6 months
Description
HbA1c (%)
Time Frame
Baseline, 3 and 6 months
Title
Change from Baseline Glucose at 3 months and 6 months
Description
Glucose (mg/dL)
Time Frame
Baseline, 3 and 6 months
Title
Change from Baseline Blood Lipids at 3 months and 6 months
Description
LDL, HDL, TRG, TC (mg/dL)
Time Frame
Baseline, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Jones, PhD, CSCS*D
Organizational Affiliation
George Mason University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Featherstone Elementary School
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22191
Country
United States
Facility Name
Kilby Elementary School
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22191
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities

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