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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Washington
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT01084590
First received: March 9, 2010
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Obesity
Injury
Behavioral: Healthy Eating/Physical Activity
Behavioral: Safety/Injury Prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Healthy Homes/Healthy Kids: Pediatric Primary Care-based Obesity Prevention

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • BMI percentile change [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Dietary intake and activity patterns [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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

  • Parenting behaviors [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • BMI percentile and psychosocial adjustment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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

  • Parent BMI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 425
Study Start Date: March 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   5 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, Prenisilone, and Decadron.
  • Families who have limited English skills.
  • Families who plan to move out of the metropolitan area within the next two years.
  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: NCT01084590

Locations
United States, Minnesota
HealthPartners Research Foundation
Bloomington, Minnesota, United States, 55425
United States, Washington
University of Washington School of Social Work
Seattle, Washington, United States, 98105
Sponsors and Collaborators
HealthPartners Institute for Education and Research
University of Washington
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Nancy E Sherwood, PhD HealthPartners Institute for Education and Research
Principal Investigator: Rona L Levy, PhD University of Washington School of Social Work
  More Information

No publications provided by HealthPartners Institute for Education and Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT01084590     History of Changes
Other Study ID Numbers: A08-132, 1R01DK084475
Study First Received: March 9, 2010
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by HealthPartners Institute for Education and Research:
Prevention
Obesity
Safety
Unhealthy weight gain
Injury prevention

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

ClinicalTrials.gov processed this record on August 19, 2014