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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University at Buffalo.
Recruitment status was  Active, not recruiting
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
  Purpose

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 Intervention
Overweight
Behavioral: family based lifestyle and behavioral counseling
Behavioral: counseling focused on the child

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Treating Overweight Youth: A Family Based Approach in Primary Care

Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • Percent BMI overweight for child and parent [ Time Frame: baseline-6,12,18, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 108
Study Start Date: April 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029834

Locations
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
Investigators
Principal Investigator: Teresa Quattrin, MD University at Buffalo/Women and Children's Hospital of Buffalo
  More Information

No publications provided by University at Buffalo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teresa Quattrin, University at Buffalo
ClinicalTrials.gov Identifier: NCT01029834     History of Changes
Other Study ID Numbers: 1R01HD053773-01
Study First Received: December 9, 2009
Last Updated: July 1, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014