Clinical trial NCT01084590: Healthy Homes/Healthy Kids_5-9
Official title: Healthy Homes/Healthy Kids: Pediatric Primary Care-based Obesity Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Injury
Keywords: Prevention
Obesity
Safety
Unhealthy weight gain
Injury prevention
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Washington
name: University of Minnesota
First posted: 2010-03-10
Enrollment: 421
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI percentile change
timeFrame: 24 months
Secondary outcomes:
measure: Dietary intake and activity patterns
timeFrame: 24 months
measure: Parenting behaviors
timeFrame: 24 months
measure: BMI percentile and psychosocial adjustment
timeFrame: 24 months
measure: Parent BMI
timeFrame: 24 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners Research Foundation
state: Minnesota
city: Seattle
country: United States
facility: University of Washington School of Social Work
state: Washington
Study officials:
affiliation: HealthPartners Institute
name: Nancy E Sherwood, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington School of Social Work
name: Rona L Levy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: JaKa MM, French SA, Wolfson J, Jeffery RW, Lorencatto F, Michie S, Levy RL, Langer SL, Sherwood NE. Understanding Outcomes in Behavior Change Interventions to Prevent Pediatric Obesity: The Role of Dose and Behavior Change Techniques. Health Educ Behav. 2019 Apr;46(2):312-321. doi: 10.1177/1090198118798679. Epub 2018 Sep 14.
citation: Kunin-Batson AS, Seburg EM, Crain AL, Jaka MM, Langer SL, Levy RL, Sherwood NE. Household factors, family behavior patterns, and adherence to dietary and physical activity guidelines among children at risk for obesity. J Nutr Educ Behav. 2015 May-Jun;47(3):206-15. doi: 10.1016/j.jneb.2015.01.002. Epub 2015 Mar 4.
citation: Sherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28.