Childhood ObesityNCT02277899
Primary Care, Communication, and Improving Children's Health
An observational study of Childhood Obesity and Overweight, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Childhood Obesity, Overweight, Communication
- What is being tested?
- Communication regarding overweight status, Risk-factor assessment and counseling and Lifestyle behavior assessment and counseling
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2014to 10 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Unstable illness (such as uncontrolled asthma)
- Developmental condition (such as trisomy 21)
- Planning to move/leave practice within two years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern and Children's Medical Center
Dallas, Texas, 75390
About this study
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.
Read the 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.
- Conditions
- Childhood Obesity, Overweight, Communication, Weight Loss
- Being tested
- Communication regarding overweight status, Risk-factor assessment and counseling, Lifestyle behavior assessment and counseling, Interval follow-up to readdress weight, Patient-centered communication
- Keywords
- childhood obesity, overweight, communication, primary care, weight management, communication methods, patient-centered communication
- Medical subject headings
- Pediatric Obesity, Overweight, Communication, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication regarding overweight statusOther
Pediatrician-patient/parent communication regarding child's high weight status
Risk-factor assessment and counselingOther
Counseling regarding cardiovascular risk factor assessments/results.
Lifestyle behavior assessment and counselingOther
Counseling regarding diet and lifestyle changes to improve weight status.
Interval follow-up to readdress weightOther
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 communicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Communication regarding overweight status; Other: Risk-factor assessment and counseling; Other: Lifestyle behavior assessment and counseling; Other: Interval follow-up to readdress weight; Other: Patient-centered communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From recorded well-child visit to next well-child visit, approximately 12 months later
Secondary outcomes (1)
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.
Measured: From recorded well-child visit to next well-child visit, approximately 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study start14 Oct 2014
- Primary completion5 Aug 2016
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christy B Turer, MD, MHS, Principal investigator, University of Texas Southwestern and Children's Medical Center Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277899
- Sponsor's protocol ID
- 1K23HL118152-01A1 Aim 2
- Other IDs
- 1K23HL118152-01A1
- Status last verified
- May 2020
- First submitted
- 27 Oct 2014
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25311599Turer 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.
PubMed 24720565Upperman 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.
PubMed 28580163Turer 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.
PubMed 26514648Turer 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.
PubMed 28239625
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care, Communication, and Improving Children's Health
- ClinicalTrials.gov ID
- NCT02277899
- Acronym / sponsor ID
- 1K23HL118152-01A1 Aim 2
- Conditions
- Childhood Obesity, Overweight, Communication, Weight Loss
- Keywords
- childhood obesity, overweight, communication, primary care, weight management, communication methods, patient-centered communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight school-age children | – | Other: Communication regarding overweight status, Other: Risk-factor assessment and counseling, Other: Lifestyle behavior assessment and counseling, Other: Interval follow-up to readdress weight, Other: Patient-centered communicationOverweight 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unstable illness (such as uncontrolled asthma)
- Developmental condition (such as trisomy 21)
- Planning to move/leave practice within two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication regarding overweight statusPediatrician-patient/parent communication regarding child's high weight status | Other | Overweight school-age children |
| Risk-factor assessment and counselingCounseling regarding cardiovascular risk factor assessments/results. | Other | Overweight school-age children |
| Lifestyle behavior assessment and counselingCounseling regarding diet and lifestyle changes to improve weight status. | Other | Overweight school-age children |
| Interval follow-up to readdress weightInterval 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. | Other | Overweight school-age children |
| Patient-centered communicationPatient-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. | Other | Overweight school-age children |
Primary outcome
Percent overweight
Time frame: From recorded well-child visit to next well-child visit, approximately 12 months later
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.
1 secondary outcome
BMI z-score
Time frame: From recorded well-child visit to next well-child visit, approximately 12 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 25311599Turer 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.
- Background: PubMed 24720565Turer 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.
- Background: PubMed 28580163Upperman 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.
- Background: PubMed 26514648Turer 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.
- Background: PubMed 28239625Turer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christy B Turer, MD, MHS principal investigator
University of Texas Southwestern and Children's Medical Center Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Overweight, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent overweight (time frame: From recorded well-child visit to next well-child visit, approximately 12 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02277899, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.