Primary Care, Communication, and Improving Children's Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-14

Study Completion Date

2017-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Primary Care Clinical Practice Elements and Improving Overweight Children's Weight Status

NCT02278705

Overweight Childhood Obesity

COMPLETED

Guided Self-Help Obesity Treatment in the Doctor's Office - GOT Doc

NCT02976454

Pediatric Obesity

COMPLETED NA

Improving Primary Care to Prevent Childhood Obesity

NCT00377767

Overweight in Preschool Age Children Risk of Overweight in Preschool Age Children

UNKNOWN PHASE1/PHASE2

Guided Self-help for Families With an Overweight Child

NCT01145833

Obesity

COMPLETED NA

Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication

NCT03074929

Obesity, Childhood

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity Overweight Communication Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Communication regarding overweight status

Intervention Type OTHER

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

Risk-factor assessment and counseling

Intervention Type OTHER

Counseling regarding cardiovascular risk factor assessments/results.

Lifestyle behavior assessment and counseling

Intervention Type OTHER

Counseling regarding diet and lifestyle changes to improve weight status.

Interval follow-up to readdress weight

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Communication regarding overweight status

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

Intervention Type OTHER

Risk-factor assessment and counseling

Counseling regarding cardiovascular risk factor assessments/results.

Intervention Type OTHER

Lifestyle behavior assessment and counseling

Counseling regarding diet and lifestyle changes to improve weight status.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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