Primary Care, Communication, and Improving Children's Health

Overweight Clinical Trial

Official title:

Primary Care, Communication, and Improving Children's Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277899
• Other study ID #: 1K23HL118152-01A1 Aim 2
• Secondary ID: 1K23HL118152-01A
• Status: Completed
• Start date: October 14, 2014
• Est. completion date: August 10, 2017

Study information

• Verified date: May 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

We will test whether 1) pediatrician-patient communication regarding overweight status, behavior/risk-factor counseling, and the frequency and time to next follow-up visit, compared with either no communication or incomplete communication (communicating only high weight status without behavior/risk-factor counseling or a follow-up visit) will predict improvement in weight status at one year follow-up, and 2) during pediatrician-patient communication regarding weight and weight management, higher patient-centeredness will predict improvement in weight status at one year follow-up. The communication content identified will generate new information about the most effective content and style of pediatrician-patient communication that predict weight-status improvement. Because we prospectively will examine clinical practice elements in the one-year interval between well-child visits, acknowledging that communication regarding high weight status may initiate assessment of risk factors for heart disease (such as high cholesterol and blood sugar), more frequent follow-up visits, or prompt a nutrition referral, we will generate novel information about the most effective clinical practices and follow-up interval and frequency that predict weight-status improvement in overweight children. We also will examine if the content and style of communication are related to improvements in diet and lifestyle behaviors at one-year follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 10, 2017
• Est. primary completion date: August 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Communication
• Overweight
• Pediatric Obesity
• Weight Loss

Intervention

Other:
• Communication regarding overweight status
Pediatrician-patient/parent communication regarding child's high weight status
• Risk-factor assessment and counseling
Counseling regarding cardiovascular risk factor assessments/results.
• Lifestyle behavior assessment and counseling
Counseling regarding diet and lifestyle changes to improve weight status.
• Interval follow-up to readdress weight
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
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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern and Children's Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Turer CB, Barlow SE, Montaño 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. — View Citation

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. — View Citation

Turer CB, Montaño 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. — View Citation

Turer CB, Upperman C, Merchant Z, Montaño 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the number of "5-2-1-0" behaviors	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.	From recorded well-child visit to next well-child visit, approximately 12 months later
Primary	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	BMI z-score	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.	From recorded well-child visit to next well-child visit, approximately 12 months later