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Healthy Homes/Healthy Kids Preschool (HHHK)

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HealthPartners Institute

Status

Completed

Conditions

Obesity

Treatments

Behavioral: Healthy Spots/Safe Tots
Behavioral: Busy Bodies/Better Bites

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01080885
R21DK078239-01A2 (U.S. NIH Grant/Contract)
08-149

Details and patient eligibility

About

The goals of this study are to evaluate the feasibility, acceptability, and potential efficacy of an innovative obesity prevention intervention integrating pediatrician counseling and a home-based program to prevent unhealthy weight gain among 2-4 year old children at risk for obesity.

Full description

The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The goals of this developmental study are to develop and evaluate the feasibility and acceptability of a primary care-based, preschool obesity prevention intervention integrating pediatrician counseling and a home-based program for parents of 2-4 year old children at risk for obesity. We propose to recruit 60 parent-child dyads from families of 2-4 year old at risk children (e.g., BMI between the 85th and 95th percentile for age and gender or a BMI between the 50th and 85th percentile and at least one overweight parent) and randomize each dyad to one of the following groups: (a) Healthy Eating/Physical Activity Intervention including brief pediatrician counseling regarding the child's current BMI%ile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction recommendations paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the obesity prevention home environmental strategies, or (b) General Health/Safety/Injury Prevention Contact Control Intervention: Families will receive the same brief counseling from their pediatrician paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the general health, safety and injury prevention home environmental strategies.

  • Healthy Eating/Physical Activity Home-based Intervention: The "Busy Bodies/Better Bites" 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 6 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: The "Healthy Tots/Safe Spots" intervention arm will include the same brief counseling from the pediatrician paired with a 6 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

60 patients

Sex

All

Ages

2 to 4 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. BMI between the 85th and 95th percentile for age and gender or
  2. BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)
  3. Receives care at a HealthPartners Clinic in the Twin Cities Metropolitan Area

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Busy Bodies/Better Bites
Experimental group
Description:
Healthy Eating/Physical Activity Intervention
Treatment:
Behavioral: Busy Bodies/Better Bites
Healthy Spots/Safe Tots
Active Comparator group
Description:
Injury Prevention and Safety Intervention
Treatment:
Behavioral: Healthy Spots/Safe Tots

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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