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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01606891
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):
University of Minnesota

Brief 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).

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: multi-component/setting parent-targeted intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Experimental: 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

Primary Outcome Measures :
  1. body mass index [ Time Frame: three years ]

Secondary Outcome Measures :
  1. energy intake [ Time Frame: three years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606891

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United States, Minnesota
University of Minnesota Division of Epidemiology & Community Health
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Simone A French, PhD University of Minnesota
Principal Investigator: Nancy E Sherwood, PhD University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Study Protocol  [PDF] May 14, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01606891    
Other Study ID Numbers: U01HD068990
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Keywords provided by University of Minnesota:
preschooler obesity prevention
community home visiting parents
preschooler excess BMI gain
multi-setting/component intervention
Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight