NET-Works:Community Preschooler Obesity Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01606891
First received: May 23, 2012
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Childhood Obesity
Behavioral: multi-component/setting parent-targeted intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • body mass index [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • energy intake [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: multi-component/setting parent-targeted intervention
experimental
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

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606891

Contacts
Contact: Simone A French, PhD 612-626-8594 frenc001@umn.edu
Contact: Nancy E Sherwood, PhD 952-967-7303 Nancy.E.Sherwood@HealthPartners.com

Locations
United States, Minnesota
University of Minnesota Division of Epidemiology & Community Health Recruiting
Minneapolis, Minnesota, United States, 55454
Principal Investigator: Simone A French, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Simone A French, PhD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Nancy E Sherwood, PhD HealthPartners Institute for Education and Research
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01606891     History of Changes
Other Study ID Numbers: U01HD068990
Study First Received: May 23, 2012
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
preschooler obesity prevention
community home visiting parents
preschooler excess BMI gain
multi-setting/component intervention

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014