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

Overweight Clinical Trial

Official title:

Treating Overweight Youth: A Family Based Approach in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029834
• Other study ID #: 1R01HD053773-01
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: June 2013

Study information

• Verified date: April 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• family based lifestyle and behavioral counseling
16 group meetings
• counseling focused on the child
16 meetings

Locations

Country	Name	City	State
United States	WNY urban practices	Buffalo	New York
United States	WNY suburban practices	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent BMI overweight for child and parent		baseline-6,12,18, 24 months
Secondary	Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity		baseline, 6,12,18,24