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Treating Pre-School Children at Risk for Overweight in the Primary Care Setting

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University at Buffalo
ClinicalTrials.gov Identifier:
NCT01029834
First received: December 9, 2009
Last updated: July 1, 2011
Last verified: June 2011
History of Changes

December 9, 2009
July 1, 2011
April 2008
April 2013   (final data collection date for primary outcome measure)
Percent BMI overweight for child and parent [ Time Frame: baseline-6,12,18, 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029834 on ClinicalTrials.gov Archive Site
Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity [ Time Frame: baseline, 6,12,18,24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treating Pre-School Children at Risk for Overweight in the Primary Care Setting
Treating Overweight Youth: A Family Based Approach in Primary Care

The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI >27 kg/m2.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Overweight
  • Behavioral: family based lifestyle and behavioral counseling
    16 group meetings
  • Behavioral: counseling focused on the child
    16 meetings
  • Experimental: Intervention- Lifestyle family based
    Behavioral family based
    Intervention: Behavioral: family based lifestyle and behavioral counseling
  • Active Comparator: Information control
    Child intervention only
    Intervention: Behavioral: counseling focused on the child
Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
108
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 2-5 year old with a BMI greater than the 85th% for age and sex
  • one overweight parent (BMI>27kg/m2)
  • child with normal developmental milestones
  • history of adherence to 90% of scheduled primary care visits
  • parent must be at 5th grade reading and speaking of English language or the spanish language
  • no plans on moving out of the area for the 2 years subsequent to enrollment

Exclusion Criteria:

  • child with a height 2 SD below the mean for age and sex and/or pathological growth velocity
  • SGA
  • any chronic disorders influencing energy intake and/or growth
  • any orthopedic disorder preventing the child or the parent from ambulation normally and performing the activity prescribed by the program
  • any medication known to have the potential of affecting weight changes
  • parent or child with psychiatric and/or eating disorder
  • participating mother who is pregnant or planning a pregnancy
  • parent being acquainted with the parent of a previously randomized study participant
Both
2 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01029834
1R01HD053773-01
Yes
Teresa Quattrin, University at Buffalo
University at Buffalo
Not Provided
Principal Investigator: Teresa Quattrin, MD University at Buffalo/Women and Children's Hospital of Buffalo
University at Buffalo
June 2011

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