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

Healthy Homes/Healthy Kids: Pediatric Primary Care-based Obesity Prevention

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Injury
• Intervention / Treatment: Behavioral: Healthy Eating/Physical Activity; Behavioral: Safety/Injury Prevention

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.

• Study Type: Interventional
• Enrollment (Actual): 421
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartners Research Foundation
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Healthy Eating/Physical Activity; 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.	Behavioral: Healthy Eating/Physical Activity; 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.
ACTIVE_COMPARATOR: Safety/Injury Prevention; 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.	Behavioral: Safety/Injury Prevention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI percentile change	Children at risk for obesity (defined as having a BMI%ile between the 75th and 85th%ile) whose parent participates in the Healthy Eating/Physical Activity Intervention will have a significantly lower BMI percentile at 12 and 24 month-follow up when compared to children whose parents participated in the Safety/Injury Prevention Intervention.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake and activity patterns	Children whose parents are in the Healthy Eating/Physical Activity Home-based Intervention participants will exhibit more favorable dietary intake and activity patterns relative to children whose parents are in the Safety/Injury Prevention group	24 months
Parenting behaviors	Parents who exhibit more parenting behaviors related to obesity prevention and higher overall adherence to pediatric primary care provider recommendations will be more successful in helping their child achieve a healthy weight gain trajectory.	24 months
BMI percentile and psychosocial adjustment	A lower increase in BMI percentile will be associated with more favorable psychosocial adjustment and that there will be no increase in disordered eating in children with parents in the Healthy Eating/Physical Activity group relative to children with parents in in the Safety/Injury Prevention group	24 months
Parent BMI	Parent attention to child weight and instruction to model healthy eating and physical activity behavior will impact parent weight, with the Healthy Eating/Physical Activity group parents having lower BMI relative to the Safety/Injury Prevention group parents.	24 months

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Washington; University of Minnesota
• Investigators: Principal Investigator: Rona L Levy, PhD, University of Washington School of Social Work

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (ESTIMATE): March 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Obesity; Prevention; Injury prevention; Unhealthy weight gain
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: A08-132; 1R01DK084475 (NIH)