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

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ClinicalTrials.gov Identifier: NCT02278705
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Christy Boling Turer, University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Overweight Childhood Obesity Other: Attention to BMI Other: Attention to high-BMI-related Medical Risk Other: No attention to high BMI or high-BMI-related medical risk

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 7192 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Primary Care Clinical Practice Elements and Improving Overweight Children's Weight Status
Study Start Date : January 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort Intervention/treatment
Weight-status improved
Cases, termed, "weight-status improved," are defined as children whose BMI percent relative to their age/sex-specific BMI at the 95th percentile decreases from one visit to the next; and from one well-child visit to the next well-child (or primary-care visit approximately 9-18 months later).
Other: Attention to BMI
Evidence (using electronic health record data) denoting provider attention to about high BMI.
Other Name: BMI

Other: Attention to high-BMI-related Medical Risk
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 Name: Medical Risk

Other: No attention to high BMI or high-BMI-related medical risk
Lack of evidence (using electronic health record data) denoting provider attention to high BMI or high-BMI-related medical risk.
Other Name: No BMI/Medical-Risk Attention

Weight-status unchanged/worse
Controls are defined as children whose BMI percent relative to their age/sex-specific BMI at the 95th percentile remains unchanged or increases from one visit to the next; and from one well-child visit to the next well-child (or primary-care visit approximately 9-18 months later).
Other: Attention to BMI
Evidence (using electronic health record data) denoting provider attention to about high BMI.
Other Name: BMI

Other: Attention to high-BMI-related Medical Risk
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 Name: Medical Risk

Other: No attention to high BMI or high-BMI-related medical risk
Lack of evidence (using electronic health record data) denoting provider attention to high BMI or high-BMI-related medical risk.
Other Name: No BMI/Medical-Risk Attention




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Overweight 6-12 year-old children followed by pediatricians at community-based and academic primary-care clinics. A random sample of controls will be matched to cases by age, gender, race/ethnicity, BMI-percentile category, and clinic site.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278705


Locations
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United States, Texas
University of Texas Southwestern and Children's Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Christy B Turer, MD, MHS University of Texas Southwestern Medical Center

Publications:
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Responsible Party: Christy Boling Turer, Assistant Professor of Pediatrics and Internal Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02278705     History of Changes
Other Study ID Numbers: 1K23HL118152-01A1 Aim 1
1K23HL118152-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christy Boling Turer, University of Texas Southwestern Medical Center:
childhood obesity
childhood overweight
primary care
weight management

Additional relevant MeSH terms:
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Overweight
Pediatric Obesity
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders