NCT00808431

Brief Summary

Preventing the onset of pediatric obesity and diabetes in Latino families The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

1.9 years

First QC Date

December 4, 2008

Last Update Submit

December 17, 2013

Conditions

Keywords

ObesityDiabetesPhysical ActivityChild FeedingGrowth TrajectoriesFamily based

Outcome Measures

Primary Outcomes (1)

  • Growth trajectories (using BMI, waist circumference), body composition

    3 months

Secondary Outcomes (1)

  • Physical activity accelerometry change over time, parental self-efficacy, child feeding questionnaire (parental food habits), identification of medical home

    3 months

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

Lifestyle counseling

Behavioral: Lifestyle counseling

Interventions

3 month skills building program emphasizing parent training, behavior modification training, nutrition education, and physical activity promotion

Also known as: Salud con la familia
Lifestyle counseling

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Latino parents with children ages 3-5
  • parent agrees to participate in all sessions
  • parent can be reached via telephone contact over next 3 months

You may not qualify if:

  • non-Latino parents
  • children outside target age range
  • parent not agreeing to participate in all sessions
  • parent cannot be reached via telephone contact over next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coleman Community Recreation Center

Nashville, Tennessee, 37211, United States

Location

Related Publications (1)

  • Barkin SL, Gesell SB, Po'e EK, Escarfuller J, Tempesti T. Culturally tailored, family-centered, behavioral obesity intervention for Latino-American preschool-aged children. Pediatrics. 2012 Sep;130(3):445-56. doi: 10.1542/peds.2011-3762. Epub 2012 Aug 6.

MeSH Terms

Conditions

Diabetes MellitusObesityMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Shari Barkin, MD, MSHS

    Vanderbilt University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 15, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 19, 2013

Record last verified: 2013-12

Locations