NET-Works:Community Preschooler Obesity Prevention (NET-Works)
|ClinicalTrials.gov Identifier: NCT01606891|
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : March 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: multi-component/setting parent-targeted intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||534 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 21, 2017|
|Actual Study Completion Date :||March 21, 2017|
Experimental: multi-component/setting parent-targeted intervention
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
No Intervention: Primary Care
Standard primary care
- body mass index [ Time Frame: three years ]
- energy intake [ Time Frame: three years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606891
|United States, Minnesota|
|University of Minnesota Division of Epidemiology & Community Health|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Simone A French, PhD||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Nancy E Sherwood, PhD||University of Minnesota - Clinical and Translational Science Institute|