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Primary Care, Communication, and Improving Children's Health

Primary Care, Communication, and Improving Children's Health

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02277899
Enrollment
100
Registered
2014-10-29
Start date
2014-10-14
Completion date
2017-08-10
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Communication, Overweight, Weight Loss

Keywords

childhood obesity, overweight, communication, primary care, weight management, communication methods, patient-centered communication

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.

Detailed 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.

Interventions

OTHERCommunication regarding overweight status

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

OTHERRisk-factor assessment and counseling

Counseling regarding cardiovascular risk factor assessments/results.

OTHERLifestyle behavior assessment and counseling

Counseling regarding diet and lifestyle changes to improve weight status.

OTHERInterval 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.

OTHERPatient-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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent overweightFrom recorded well-child visit to next well-child visit, approximately 12 months laterThe 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.

Secondary

MeasureTime frameDescription
BMI z-scoreFrom recorded well-child visit to next well-child visit, approximately 12 months laterChange 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.

Other

MeasureTime frameDescription
Change in the number of 5-2-1-0 behaviorsFrom recorded well-child visit to next well-child visit, approximately 12 months laterThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026