Clinical trial NCT01080885: Healthy Homes/Healthy Kids Preschool
Official title: Linking Home Environments and Primary Care: Obesity Prevention for 2-5 Year Olds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Prevention
Prevention of unhealthy weight gain
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parent and pediatrician participation and satisfaction
timeFrame: 6 months
measure: Healthy Eating
timeFrame: 6 months
measure: Levels of TV watching
timeFrame: 6 months
measure: Physical activity levels
timeFrame: 6 months
Secondary outcomes:
measure: Hypothesized mediators of BMI change
timeFrame: 6 months
measure: Body mass index (BMI) percentile
timeFrame: 6 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners Research Foundation
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Nancy E Sherwood, PhD
role: PRINCIPAL_INVESTIGATOR
References: