Overview

This trial is active, not recruiting.

Condition childhood obesity
Treatment multi-component/setting parent-targeted intervention
Phase phase 3
Sponsor University of Minnesota - Clinical and Translational Science Institute
Start date June 2012
End date March 2017
Trial size 500 participants
Trial identifier NCT01606891, U01HD068990

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Arm
(Experimental)
experimental
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)
Standard primary care

Primary Outcomes

Measure
body mass index
time frame: three years

Secondary Outcomes

Measure
energy intake
time frame: three years

Eligibility Criteria

Male or female participants from 2 years up to 4 years old.

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

Additional Information

Official title Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers
Principal investigator Simone A French, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.