MedTrace Logo

NET-Works:Community Preschooler Obesity Prevention

NCT01606891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2018-10-15

No results posted yet for this study

Summary

The goal of the Minnesota center is to integrate primary care, home, and community-based intervention strategies to promote sustained patterns of change in food intake, physical activity, and body weight among low income, ethnically diverse children. A culturally matched family connector will create linkages among the settings to support parents in making home environment and parenting behavior changes conducive to healthy growth and development in their children.

Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted randomized controlled intervention on the primary outcome, child BMI, compared to a standard primary care-only intervention among 500 low income ethnic minority two to four year old children who are at or above the 50th percentile of BMI for age and gender.

Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower BMI at 24 and 36 months, compared with children in the standard primary care only control group.

Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted intervention on secondary outcomes, including change in child energy intake and physical activity energy expenditure, compared to a standard primary care-only intervention.

Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower energy intake and higher energy expenditure over the three-year period, compared with children in the standard primary care-only control group.

Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on hypothesized mediators of change in dietary intake, physical activity, and BMI.

Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and physical activity environment will mediate changes in child energy intake and expenditure, and body mass index (BMI).

Conditions

  • Childhood Obesity

Interventions

BEHAVIORAL

multi-component/setting parent-targeted intervention

parents assigned to this group will be asked to participate in a program of home visiting, community parenting classes, and community food and physical activity resource links

Sponsors & Collaborators

Principal Investigators

  • Simone A French, PhD · University of Minnesota

  • Nancy E Sherwood, PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2017-03-21
Completion
2017-03-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01606891 on ClinicalTrials.gov