CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 534 enrolled
Drug / intervention
multi-component/setting parent-targeted interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01606891
NCT01606891N/ACompleted

Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers

University of Minnesota·interventional·Posted May 28, 2012·Updated Oct 15, 2018

In Brief

A clinical study evaluating multi-component/setting parent-targeted intervention for Childhood Obesity. Completed, enrolled 534 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2012
Enrollment StartJun 1, 2012
Primary CompletionMar 21, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.1 years ago

Interventions

multi-component/setting parent-targeted interventionbehavioral

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