- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277899
Primary Care, Communication, and Improving Children's Health
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern and Children's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Schedule a well-child visit with a participating pediatrician
- Agree to return in one year for the follow-up well-child visit
- Overweight
- 6-12 years old
- Have a working telephone and/or e-mail address
- Child/parent willing to provide assent/consent
Exclusion Criteria:
- Unstable illness (such as uncontrolled asthma)
- Developmental condition (such as trisomy 21)
- Planning to move/leave practice within two years
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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:
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Pediatrician-patient/parent communication regarding child's high weight status
Counseling regarding cardiovascular risk factor assessments/results.
Counseling regarding diet and lifestyle changes to improve weight status.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent overweight
Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later
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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.
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From recorded well-child visit to next well-child visit, approximately 12 months later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI z-score
Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later
|
Change in BMI z-score of 0.25-0.5 has been associated with reductions in cardiovascular-disease risk factors.
Using both percent overweight and BMI z-score measures will allow examination of the relationship between relative weight changes and cardiovascular-disease risk-factor improvement.
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From recorded well-child visit to next well-child visit, approximately 12 months later
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the number of "5-2-1-0" behaviors
Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later
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The "5-2-1-0" behaviors are: eat five fruits and vegetables, watch "screens" (TV, computer, tablets, video games, cell phones, etc…) two hours per day or less, be physically active for one hour per day or more, and drink zero calorie-containing beverages per day.
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From recorded well-child visit to next well-child visit, approximately 12 months later
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christy B Turer, MD, MHS, University of Texas Southwestern and Children's Medical Center Dallas
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1K23HL118152-01A1 Aim 2
- 1K23HL118152-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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