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

University at Buffalo (UB) logo

University at Buffalo (UB)

Status

Completed

Conditions

Overweight

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01029834
1R01HD053773-01

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

2 to 6 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 2 patient groups

Intervention- Lifestyle family based
Experimental group
Description:
Behavioral family based
Treatment:
Behavioral: family based lifestyle and behavioral counseling
Information control
Active Comparator group
Description:
Child intervention only
Treatment:
Behavioral: counseling focused on the child

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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