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Healthy Homes/Healthy Kids Preschool (HHHK)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT01080885
First received: March 3, 2010
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Busy Bodies/Better Bites
Behavioral: Healthy Spots/Safe Tots

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Linking Home Environments and Primary Care: Obesity Prevention for 2-5 Year Olds

Resource links provided by NLM:

MedlinePlus related topics: Obesity Rashes
U.S. FDA Resources

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

Primary Outcome Measures:
  • Parent and pediatrician participation and satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Parents of at risk preschool children and pediatricians will show high participation rates in and report high levels of satisfaction with the interventions.

  • Healthy Eating [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of sweetened beverage and higher levels of lower fat/calorie snack and meal consumption compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. The Nutrition Data System for Research will be used to measure this change.

  • Levels of TV watching [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of TV watching compared to Safety/Injury Prevention Home-based Contact Control Intervention participants;

  • Physical activity levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Healthy Eating/Physical Activity Home-based Intervention participants will show higher levels of physical activity compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. Physical activity level will be measured by accelerometry.


Secondary Outcome Measures:
  • Hypothesized mediators of BMI change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Parents in the Healthy Eating/Physical Activity Home-based Intervention will report more favorable levels of hypothesized mediators of BMI change (e.g., family meal frequency, availability of lower fat/calorie foods and physical activity opportunities) compared to Safety/Injury Prevention Home-based Contact Control Intervention participants.

  • Body mass index (BMI) percentile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Participation in the Healthy Eating/Physical Activity Home-based Intervention will lead to reduced BMI percentile compared to Safety/Injury Prevention Home-based Contact Control Intervention participant.


Enrollment: 60
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Busy Bodies/Better Bites
Healthy Eating/Physical Activity Intervention
 Behavioral: Busy Bodies/Better Bites
This intervention will include 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 healthy eating and physical activity home environmental strategies.
Active Comparator: Healthy Spots/Safe Tots
Injury Prevention and Safety Intervention
 Behavioral: Healthy Spots/Safe Tots
This intervention 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.

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

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080885

Locations
United States, Minnesota
HealthPartners Research Foundation
Bloomington, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute for Education and Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Nancy E Sherwood, PhD HealthPartners Institute for Education and Research
  More Information

No publications provided

Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT01080885     History of Changes
Other Study ID Numbers: 08-149, R21DK078239-01A2
Study First Received: March 3, 2010
Last Updated: April 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by HealthPartners Institute for Education and Research:
Prevention
Prevention of unhealthy weight gain

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

ClinicalTrials.gov processed this record on May 16, 2013