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NET-Works:Community Preschooler Obesity Prevention (NET-Works)

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ClinicalTrials.gov Identifier: NCT01606891
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

May 23, 2012
May 28, 2012
March 31, 2017
June 2012
March 21, 2017   (Final data collection date for primary outcome measure)
body mass index [ Time Frame: three years ]
Same as current
Complete list of historical versions of study NCT01606891 on ClinicalTrials.gov Archive Site
energy intake [ Time Frame: three years ]
Same as current
Not Provided
Not Provided
 
NET-Works:Community Preschooler Obesity Prevention
Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Childhood Obesity
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
  • Experimental: multi-component/setting parent-targeted intervention
    experimental
    Intervention: Behavioral: multi-component/setting parent-targeted intervention
  • No Intervention: Primary Care
    Standard primary care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
534
March 21, 2017
March 21, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A child and his or her parent(s) will be eligible for the study if:

    • the two to four year old child is scheduled to receive or eligible for (based on an upcoming birthday) a recommended well child visit conducted by a pediatric or family practice care provider;
    • the child has no medical problems that would preclude study participation as determined by the physician conducting the well child visit (e.g. serious disease that would make following guidelines for parent encouragement of healthy diet and physical activity infeasible);
    • the child's BMI is greater than or equal to the 50th percentile according to CDC age and sex reference standards http://www.cdc.gov/nchs/data/nhanes/growthcharts/bmiage.txt;
    • the child's parent/guardian agrees to participation in the study and is not planning to move out of the state in the next three years
    • the primary caregiver is willing and able to complete the evaluation measures and participate in intervention activities if assigned to the active intervention group.
    • the parent speaks either English or Spanish.

Exclusion Criteria:

  • A child will be excluded if she or he does not meet the above eligibility criteria
Sexes Eligible for Study: All
2 Years to 4 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01606891
U01HD068990
Yes
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
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
University of Minnesota - Clinical and Translational Science Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP