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

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Behavioral: family based lifestyle and behavioral counseling; Behavioral: counseling focused on the child

• Registration Number: NCT01029834
• Lead Sponsor: State University of New York 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention- Lifestyle family based	family based lifestyle and behavioral counseling	Behavioral family based
Information control	counseling focused on the child	Child intervention only

Primary Outcome Measures

Name	Time	Method
Percent BMI overweight for child and parent	baseline-6,12,18, 24 months

Secondary Outcome Measures

Name	Time	Method
Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity	baseline, 6,12,18,24

Trial Locations

Locations (2)

WNY urban practices; 🇺🇸 Buffalo, New York, United States

WNY suburban practices; 🇺🇸 Williamsville, New York, United States