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OpenTrials
Completed

NCT Number: NCT02278705

Primary Care Clinical Practice Elements and Improving Overweight Children's Weight Status

The purpose of this study is to identify whether specific clinical practices-including attention to body-mass-index (BMI) screening/overweight/obesity, medical risk (from conditions associated with overweight/obesity such as high blood pressure), and following up to reassess progress-will improve the weight status of overweight school-age children.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern and Children's Medical Center

Dallas, Texas, 75390, United States

About this study

The aim of this study is to identify specific clinical practice elements in pediatric primary care that predict improvement in weight status among overweight school-age children. Pediatricians are well-suited to regularly assess and treat school-age children who are overweight. Well-child visits present an important opportunity to assess and treat overweight children. Strategies are needed to maximize the effectiveness of this opportunity. Although the American Academy of Pediatrics endorses recommendations by the United States Preventive Services Task Force that clinicians screen for overweight, assess medical/behavior risk, and use a staged treatment approach that includes frequent reassessment, it is unclear whether these practices, when used in primary care, impact whether children make lifestyle changes or improve their weight status. It is essential to identify specific clinical practice elements and communication strategies associated with weight-status improvement in overweight children, to maximize the effectiveness of primary-care weight-management interventions. The investigators hypothesize that, during primary-care visits with overweight 6-12-year-old children, attention to high BMI, medical risk (from weight-related comorbidities such as high blood pressure), and reassessing progress (defined as having a primary-care visit with evidence of attention to BMI or completing a referral to a weight-management specialist or nutritionist) will be associated with improvement in weight status (assessed as decrease in percent overweight (percentage above the age/sex-specific 95th BMI percentile) at follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 6-12 year-old children with ≥2 visits
  • valid height and weight data at each visit
  • BMI ≥85th percentile at the first visit

Exclusion criteria

  • children <6 and >12 years old
  • no valid height and weight data at two visits
  • BMI <85th percentile at all 6-12 year-old well child visits

Treatment and study plan

Attention to BMI

Other

Evidence (using electronic health record data) denoting provider attention to about high BMI.

Other names: BMI

Attention to high-BMI-related Medical Risk

Other

Evidence (using electronic health record data) denoting provider attention to high-BMI-related medical risk, including from high blood pressure/hypertension, cholesterol/dyslipidemia, blood sugar/diabetes, liver enzymes/fatty liver, and low vitamin D/vitamin-D deficiency.

Other names: Medical Risk

No attention to high BMI or high-BMI-related medical risk

Other

Lack of evidence (using electronic health record data) denoting provider attention to high BMI or high-BMI-related medical risk.

Other names: No BMI/Medical-Risk Attention

Primary outcomes

  1. weight-status improvement

    Time frame: From one visit to the next and from one well-child visit to the next

    Children with a decrease in BMI percent relative to the age/sex-specific BMI at the 95th percentile

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2014
Registry last updated
May 19, 2020

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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