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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04677582
Other study ID # 117702
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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