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OpenTrials
Completed

NCT Number: NCT01029834

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

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.

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Key information

Conditions

Overweight Behavior Body Weight Coitus Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WNY urban practices, Buffalo, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

family based lifestyle and behavioral counseling

Behavioral

16 group meetings

counseling focused on the child

Behavioral

16 meetings

Primary outcomes

  1. Percent BMI overweight for child and parent

    Time frame: baseline-6,12,18, 24 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Treating Overweight Youth: A Family Based Approach in Primary Care

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2009
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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