ClinicalTrials.Veeva

Menu

Healthy Homes/Healthy Kids_5-9 (HHHK_5-9)

HealthPartners Institute logo

HealthPartners Institute

Status

Completed

Conditions

Obesity
Injury

Treatments

Behavioral: Safety/Injury Prevention
Behavioral: Healthy Eating/Physical Activity

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01084590
1R01DK084475 (U.S. NIH Grant/Contract)
A08-132

Details and patient eligibility

About

The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based obesity prevention intervention. The intervention will consist of brief pediatrician counseling as well as phone coaching for parents with overweight children who are between the ages of five and nine. We propose to enroll and randomize 425 parent-child dyads with children who have a measured body mass index (BMI) the 75th and 95th percentile. They will be randomized one of into two groups, the (a) Healthy Eating/Physical Activity Intervention, or the (b) General Healthy/Safety/Injury Prevention Contact Control Intervention. Both groups will receive brief pediatrician counseling regarding their child's current BMI percentile status and recommendations for home environmental changes to achieve a healthy weight gain trajectory and to improve home safety and reduce injury risk. This will be paired with a 12 month home-based program delivered via phone by health behavior specialists to help parents make environmental changes specific to their group assignment.

Full description

The goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based intervention that integrates brief pediatric counseling and a home-based phone program to prevent unhealthy weight gain in overweight children ages five-nine. Parent-child dyads will be recruited for the Healthy Homes/Healthy Kids Study via a multi-step process including use of electronic medical record data to identify children, pediatrician approval, and outreach via letters and phone calls. Four hundred and twenty five parent-child dyads from pediatric primary care will be recruited to participate and be randomized to one of two interventions:

Healthy Eating/Physical Activity Home-based Intervention: This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.

Safety/Injury Prevention Home-based Contact Control Intervention: This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.

Enrollment

421 patients

Sex

All

Ages

5 to 9 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI%ile between the 75th and 95th%ile
  • Receives care at a HealthPartners Clinic in the Twin Cities Metropolitan Area

Exclusion criteria

  • Children with the following chronic conditions: kidney disease, Type 1 diabetes, lupus, a thyroid condition, cancer, or chromosomal abnormality such as Down's syndrome or Turner's syndrome
  • Children who within the last six months or those who are currently taking the following medications and took them or will be taking them for more than a month: Prednisone, Prednisilone, and Decadron.
  • Families who have limited English skills.
  • Families who plan to move out of the metropolitan area within the next two years.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

421 participants in 2 patient groups

Healthy Eating/Physical Activity
Experimental group
Description:
This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.
Treatment:
Behavioral: Healthy Eating/Physical Activity
Safety/Injury Prevention
Active Comparator group
Description:
This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.
Treatment:
Behavioral: Safety/Injury Prevention

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems