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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
family based lifestyle and behavioral counseling
counseling focused on the child
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring BMI >85%for age and gender

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • WNY urban practices
  • WNY suburban practices

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention- Lifestyle family based

Information control

Arm Description

Behavioral family based

Child intervention only

Outcomes

Primary Outcome Measures

Percent BMI overweight for child and parent

Secondary Outcome Measures

Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity

Full Information

First Posted
December 9, 2009
Last Updated
April 26, 2023
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT01029834
Brief Title
Treating Pre-School Children at Risk for Overweight in the Primary Care Setting
Official Title
Treating Overweight Youth: A Family Based Approach in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
BMI >85%for age and gender

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention- Lifestyle family based
Arm Type
Experimental
Arm Description
Behavioral family based
Arm Title
Information control
Arm Type
Active Comparator
Arm Description
Child intervention only
Intervention Type
Behavioral
Intervention Name(s)
family based lifestyle and behavioral counseling
Intervention Description
16 group meetings
Intervention Type
Behavioral
Intervention Name(s)
counseling focused on the child
Intervention Description
16 meetings
Primary Outcome Measure Information:
Title
Percent BMI overweight for child and parent
Time Frame
baseline-6,12,18, 24 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Quattrin, MD
Organizational Affiliation
University at Buffalo/Women and Children's Hospital of Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
WNY urban practices
City
Buffalo
State/Province
New York
Country
United States
Facility Name
WNY suburban practices
City
Williamsville
State/Province
New York
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25049340
Citation
Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Treatment outcomes of overweight children and parents in the medical home. Pediatrics. 2014 Aug;134(2):290-7. doi: 10.1542/peds.2013-4084.
Results Reference
derived
PubMed Identifier
22987879
Citation
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.
Results Reference
derived

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

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