NCT02277899

Brief Summary

The purpose of this study is to determine communication content and strategies in primary care that predict improvement in weight status among overweight school-age children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration 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

October 14, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

October 27, 2014

Last Update Submit

May 15, 2020

Conditions

Keywords

childhood obesityoverweightcommunicationprimary careweight managementcommunication methodspatient-centered communication

Outcome Measures

Primary Outcomes (1)

  • Percent overweight

    The percent over the median BMI percentile for age and gender. This measure changes comparably for similar weight changes in overweight and severely-obese children. In contrast, an overweight child would have to lose substantially less weight than a severely-obese child for the same change in BMI z-score.

    From recorded well-child visit to next well-child visit, approximately 12 months later

Secondary Outcomes (1)

  • BMI z-score

    From recorded well-child visit to next well-child visit, approximately 12 months later

Other Outcomes (1)

  • Change in the number of "5-2-1-0" behaviors

    From recorded well-child visit to next well-child visit, approximately 12 months later

Study Arms (1)

Overweight school-age children

Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded. The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include: 1. Communication regarding child's high weight status 2. Counseling regarding cardiovascular risk factor screening and assessment 3. Behavioral counseling 4. Interval follow-up to readdress weight, and 5. Patient-centeredness, scored as the ratio of patient to doctor-centered communication regarding weight topics.

Other: Communication regarding overweight statusOther: Risk-factor assessment and counselingOther: Lifestyle behavior assessment and counselingOther: Interval follow-up to readdress weightOther: Patient-centered communication

Interventions

Pediatrician-patient/parent communication regarding child's high weight status

Overweight school-age children

Counseling regarding cardiovascular risk factor assessments/results.

Overweight school-age children

Counseling regarding diet and lifestyle changes to improve weight status.

Overweight school-age children

Interval follow-up to readdress weight, prior to the next well-child visit one year later. Follow-up could include ongoing care through nutrition and/or an intensive weight-management program.

Overweight school-age children

Patient-centered communication will be scored as the ratio of patient to doctor-centered communication regarding weight topics. Means will be calculated for total and weight-communication-specific pediatrician, child, and parent-talk time, and patient, doctor, and the ratio of patient/doctor-centered communication scores. For the primary hypothesis, biomedical information-giving (for example, risk-factor communication) will be treated as patient-centered because the principal investigator's focus groups suggest that parents want this information, and prior research suggests that including biomedical-information giving improves the correlation of Roter's patient-centeredness measure with patient health status and satisfaction scores.

Overweight school-age children

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

We will recruit pediatricians (from academic, community, and private practices), children, and a consenting parent. Pediatricians and children will be selected to reflect the proportions of minority pediatricians and children in the practices. Pediatricians at the community and private practices will be eligible to participate if they provide outpatient pediatric care ≥20 hours/week. At the academic clinic, only second and third-year residents will be eligible. Eighty-five children and a consenting parent will be recruited.

You may qualify if:

  • Schedule a well-child visit with a participating pediatrician
  • Agree to return in one year for the follow-up well-child visit
  • Overweight
  • years old
  • Have a working telephone and/or e-mail address
  • Child/parent willing to provide assent/consent

You may not qualify if:

  • Unstable illness (such as uncontrolled asthma)
  • Developmental condition (such as trisomy 21)
  • Planning to move/leave practice within two years

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

Pediatric ObesityOverweightCommunicationWeight Loss

Interventions

Counseling

Condition Hierarchy (Ancestors)

ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Christy B Turer, MD, MHS

    University of Texas Southwestern and Children's Medical Center Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 29, 2014

Study Start

October 14, 2014

Primary Completion

August 5, 2016

Study Completion

August 10, 2017

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations