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

NCT ID: NCT02278705

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7192 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Overweight; Childhood Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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).

Attention to BMI

Intervention Type: OTHER

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

Attention to high-BMI-related Medical Risk

Intervention Type: 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.

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

Intervention Type: OTHER

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

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).

Attention to BMI

Intervention Type: OTHER

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

Attention to high-BMI-related Medical Risk

Intervention Type: 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.

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

Intervention Type: OTHER

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

Interventions

Attention to BMI

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

BMI; Medical Risk; No BMI/Medical-Risk Attention

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christy B Turer, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern and Children's Medical Center

Dallas, Texas, United States

Countries

United States

References

Turer CB, Montano 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.

Reference Type: BACKGROUND

PMID: 25311599 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24720565 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28580163 (View on PubMed)

Turer CB, Upperman C, Merchant Z, Montano 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.

Reference Type: BACKGROUND

PMID: 26514648 (View on PubMed)

Turer CB, Barlow SE, Montano 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.

Reference Type: BACKGROUND

PMID: 28239625 (View on PubMed)

Other Identifiers

1K23HL118152-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1K23HL118152-01A1 Aim 1

Identifier Type: -

Identifier Source: org_study_id