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

Completed

• Conditions: Childhood Obesity; Overweight
• Interventions: Other: Attention to BMI; Other: Attention to high-BMI-related Medical Risk; Other: No attention to high BMI or high-BMI-related medical risk

• Registration Number: NCT02278705
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2014-10-24
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-30
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7192

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Weight-status unchanged/worse	Attention to BMI	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).
Weight-status unchanged/worse	Attention to high-BMI-related Medical Risk	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).
Weight-status improved	Attention to BMI	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).
Weight-status unchanged/worse	No attention to high BMI or high-BMI-related medical risk	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).
Weight-status improved	Attention to high-BMI-related Medical Risk	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).
Weight-status improved	No attention to high BMI or high-BMI-related medical risk	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).

Primary Outcome Measures

Name	Time	Method
weight-status improvement	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

Trial Locations

Locations (1)

University of Texas Southwestern and Children's Medical Center; 🇺🇸 Dallas, Texas, United States