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NCT Number: NCT01084590

Healthy Homes/Healthy Kids_5-9

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.

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Key information

Conditions

Obesity Body Weight Injury Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Research Foundation, Bloomington, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Eating/Physical Activity

Behavioral

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

Behavioral

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.

Primary outcomes

  1. BMI percentile change

    Time frame: 24 months

    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 outcomes

  1. Dietary intake and activity patterns

    Time frame: 24 months

    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

  2. Parenting behaviors

    Time frame: 24 months

    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.

  3. BMI percentile and psychosocial adjustment

    Time frame: 24 months

    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

  4. Parent BMI

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Minnesota
  • University of Washington

Registry information

Official study title

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

Acronym: HHHK_5-9

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 10, 2010
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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