NCT04677582

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:

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2018

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

3.7 years

First QC Date

August 9, 2018

Last Update Submit

December 18, 2020

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Behavioral: Vidas Activas, famiLias saludablEs (VALE)

Interventions

Vidas Activas, famiLias saludablEs (VALE)BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Featherstone Elementary School

Woodbridge, Virginia, 22191, United States

Location

Kilby Elementary School

Woodbridge, Virginia, 22191, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Margaret Jones, PhD, CSCS*D

    George Mason University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2018

First Posted

December 21, 2020

Study Start

October 4, 2017

Primary Completion

June 20, 2021

Study Completion

July 1, 2021

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)