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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278705
• Other study ID #: 1K23HL118152-01A1 Aim 1
• Secondary ID: 1K23HL118152-01A
• Status: Completed
• Start date: January 2009
• Est. completion date: September 2015

Study information

• Verified date: May 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7192
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Overweight
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern and Children's Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Turer CB, Barlow SE, Montaño S, Flores G. Discrepancies in Communication Versus Documentation of Weight-Management Benchmarks: Analysis of Recorded Visits With Latino Children and Associated Health-Record Documentation. Glob Pediatr Health. 2017 Feb 6;4:2333794X16685190. doi: 10.1177/2333794X16685190. eCollection 2017. — View Citation

Turer CB, Mehta M, Durante R, Wazni F, Flores G. Parental perspectives regarding primary-care weight-management strategies for school-age children. Matern Child Nutr. 2016 Apr;12(2):326-38. doi: 10.1111/mcn.12131. Epub 2014 Apr 10. — View Citation

Turer CB, Montaño S, Lin H, Hoang K, Flores G. Pediatricians' communication about weight with overweight Latino children and their parents. Pediatrics. 2014 Nov;134(5):892-9. doi: 10.1542/peds.2014-1282. Epub 2014 Oct 13. — View Citation

Turer CB, Upperman C, Merchant Z, Montaño S, Flores G. Primary-Care Weight-Management Strategies: Parental Priorities and Preferences. Acad Pediatr. 2016 Apr;16(3):260-6. doi: 10.1016/j.acap.2015.09.001. Epub 2015 Sep 26. — View Citation

Upperman C, Palmieri P, Lin H, Flores G, Turer CB. What do parents want for their children who are overweight when visiting the paediatrician? Obes Sci Pract. 2015 Oct;1(1):33-40. doi: 10.1002/osp4.5. Epub 2015 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight-status improvement	Children with a decrease in BMI percent relative to the age/sex-specific BMI at the 95th percentile	From one visit to the next and from one well-child visit to the next