NCT02278705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,192

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

6.7 years

First QC Date

October 24, 2014

Last Update Submit

May 15, 2020

Conditions

Keywords

childhood obesitychildhood overweightprimary careweight management

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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 BMIOther: Attention to high-BMI-related Medical RiskOther: No 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).

Other: Attention to BMIOther: Attention to high-BMI-related Medical RiskOther: No attention to high BMI or high-BMI-related medical risk

Interventions

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

Also known as: BMI
Weight-status improvedWeight-status unchanged/worse

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.

Also known as: Medical Risk
Weight-status improvedWeight-status unchanged/worse

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

Also known as: No BMI/Medical-Risk Attention
Weight-status improvedWeight-status unchanged/worse

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern and Children's Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (5)

  • 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.

    PMID: 25311599BACKGROUND
  • 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.

    PMID: 24720565BACKGROUND
  • 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.

    PMID: 28580163BACKGROUND
  • 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.

    PMID: 26514648BACKGROUND
  • 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.

    PMID: 28239625BACKGROUND

MeSH Terms

Conditions

OverweightPediatric Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsObesity

Study Officials

  • Christy B Turer, MD, MHS

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2014

First Posted

October 30, 2014

Study Start

January 1, 2009

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations