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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

March 3, 2010
April 20, 2012
July 2010
July 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01080885 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Healthy Homes/Healthy Kids Preschool
Linking Home Environments and Primary Care: Obesity Prevention for 2-5 Year Olds

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
  • 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.
  • 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.
  • Experimental: Busy Bodies/Better Bites
    Healthy Eating/Physical Activity Intervention
    Intervention: Behavioral: Busy Bodies/Better Bites
  • Active Comparator: Healthy Spots/Safe Tots
    Injury Prevention and Safety Intervention
    Intervention: Behavioral: Healthy Spots/Safe Tots
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
2 Years to 4 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01080885
08-149, R21DK078239-01A2
Yes
HealthPartners Institute for Education and Research
HealthPartners Institute for Education and Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Nancy E Sherwood, PhD HealthPartners Institute for Education and Research
HealthPartners Institute for Education and Research
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP