Trial record 1 of 2 for:    22987879 [PUBMED-IDS]
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Treating Pre-School Children at Risk for Overweight in the Primary Care Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01029834
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):
Teresa Quattrin, University at Buffalo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight Behavioral: family based lifestyle and behavioral counseling Behavioral: counseling focused on the child Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Treating Overweight Youth: A Family Based Approach in Primary Care
Study Start Date : April 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Intervention- Lifestyle family based
Behavioral family based
Behavioral: family based lifestyle and behavioral counseling
16 group meetings

Active Comparator: Information control
Child intervention only
Behavioral: counseling focused on the child
16 meetings

Primary Outcome Measures :
  1. Percent BMI overweight for child and parent [ Time Frame: baseline-6,12,18, 24 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01029834

United States, New York
WNY urban practices
Buffalo, New York, United States
WNY suburban practices
Willaimsville, New York, United States
Sponsors and Collaborators
University at Buffalo
Principal Investigator: Teresa Quattrin, MD University at Buffalo/Women and Children's Hospital of Buffalo

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Teresa Quattrin, Chief, Division of Diabetes/Endocrinology, University at Buffalo Identifier: NCT01029834     History of Changes
Other Study ID Numbers: 1R01HD053773-01 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by Teresa Quattrin, University at Buffalo:
BMI >85%for age and gender

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms