CommunicationTeenCHATNCT01040975
Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight
A study testing Web-based intervention targeting MD communication; Summary Report in people with Communication and Obesity, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to teach primary care physicians effective ways to counsel overweight and obese adolescent patients to attain a healthy weight. Fifty physicians and up to 660 adolescent patients from Duke University Health System (DUHS) Primary Care Clinics will take part in this study. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Communication, Obesity, Nutrition
- What is being tested?
- Web-based intervention targeting MD communication; Summary Report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Feb 2014
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Specialty is Family Practice or Pediatrics
- Located in participating clinic
- Not planning to leave clinic in the next two years
- English-speaking
- BMI z-score >85th percentile
- age 12-18
Show all 10Show fewer
- not pregnant
- have parental consent to participate if over 18
- have visit at least 7 days in the future
- have access to a telephone
Who cannot join
- BMI z-score <85th percentile
- not English speaking
- pregnant
- <12 or older than 18
- incompetent for interview
- seen primarily by non-physician provider
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center - Cancer Prevention, Detection and Control
Durham, North Carolina, 27710
About this study
The purpose of this study is to teach primary care physicians effective ways to counsel overweight and obese adolescent patients to attain a healthy weight. Fifty physicians and up to 660 adolescent patients from Duke University Health System (DUHS) Primary Care Clinics will take part in this study.
Patients will be identified by research study staff and asked if they would be willing to have their clinic visit audio recorded for research purposes. There are three phases of data collection. First, baseline encounters (n=200, 4 per physician) are audio recorded. Then, half of the physicians will be randomized to receive a tailored web-based intervention containing information about evidence-based techniques to help adolescents attain a healthy weight. A new set of 200 encounters (4 per physician) will be audio recorded. Then, all physicians will receive a Summary Report that outlines the adolescent's high risk behaviors that contribute to weight (sweetened beverages, fast food, breakfast, physical activity, screen time, and sleep) and a new set of 200 encounters will be audio recorded.
Data will be collected by trained data technicians, in-person and over the phone. Data is collected on laptop computers and then downloaded into password protected electronic files on a secure network server. All participants (adolescent patients and physicians) will be assigned a code number that is the sole identifier on all study data forms. Prior to and after coding, digital files will be stored in password protected directories to which only the data technicians and project manager have access. The web-based intervention will be password protected.
- Conditions
- Communication, Obesity, Nutrition, Physical Activity, Sleep
- Being tested
- Web-based intervention targeting MD communication; Summary Report
- Medical subject headings
- Communication, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based intervention targeting MD communication; Summary ReportBehavioural
Also called Tailored Web-based intervention developed by study team, Tailored Summary Report
Web-based intervention targeting MD communication; Summary Report detailing 6 risk factors for adolescent overweight/obesity developed by study team
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing intervention | Experimental | Web-based intervention targeting MD communication and Summary Report Receives: Behavioral: Web-based intervention targeting MD communication; Summary Report |
| Control | No intervention | MD receives Summary Report only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician communication
Measured: after CD-ROM phase
Secondary outcomes (2)
Summary Report
Assess whether summary report increases whether physicians address six health risk behaviors
Measured: After Summary Report Phase
Adolescent Nutrition, Physical Activity, and BMI Z-score
Examine whether patients whose MD was in the MI education arm improved their nutrition, physical activity, and BMI z-score 3 months post-visit more than patients whose MD was in the control arm.
Measured: 3 months post-visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2013
- Study completionFeb 2014
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 CommunicationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kathryn I Pollak, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040975
- Sponsor's protocol ID
- Pro00016206
- Other IDs
- 1R01HL092403-01A2
- Acronym
- TeenCHAT
- Status last verified
- Sep 2016
- First submitted
- 29 Dec 2009
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bodner ME, Lyna P, Ostbye T, Bravender T, Alexander SC, Tulsky JA, Lin PH, Pollak KI. Accuracy and congruence of physician and adolescent patient weight-related discussions: Teen CHAT (Communicating health: Analyzing talk). Patient Educ Couns. 2018 Dec;101(12):2105-2110. doi: 10.1016/j.pec.2018.07.022. Epub 2018 Jul 26.
PubMed 30115415Pollak KI, Tulsky JA, Bravender T, Ostbye T, Lyna P, Dolor RJ, Coffman CJ, Bilheimer A, Lin PH, Farrell D, Bodner ME, Alexander SC. Teaching primary care physicians the 5 A's for discussing weight with overweight and obese adolescents. Patient Educ Couns. 2016 Oct;99(10):1620-5. doi: 10.1016/j.pec.2016.05.007. Epub 2016 May 9.
PubMed 27228899Pollak KI, Coffman CJ, Tulsky JA, Alexander SC, Ostbye T, Farrell D, Lyna P, Dolor RJ, Bilheimer A, Lin PH, Bodner ME, Bravender TD. Teaching Physicians Motivational Interviewing for Discussing Weight With Overweight Adolescents. J Adolesc Health. 2016 Jul;59(1):96-103. doi: 10.1016/j.jadohealth.2016.03.026. Epub 2016 May 5.
PubMed 27155958Ostbye T, Lyna P, Bodner ME, Alexander SC, Coffman C, Tulsky JA, Dolor R, Pollak K. The Effect of Parental Presence on Weight-Related Discussions Between Physicians and Their Overweight Adolescent Patients. Clin Pediatr (Phila). 2015 Oct;54(12):1218-20. doi: 10.1177/0009922814566027. Epub 2015 Jan 9. No abstract available.
PubMed 25575503Alexander SC, Fortenberry JD, Pollak KI, Bravender T, Davis JK, Ostbye T, Tulsky JA, Dolor RJ, Shields CG. Sexuality talk during adolescent health maintenance visits. JAMA Pediatr. 2014 Feb;168(2):163-9. doi: 10.1001/jamapediatrics.2013.4338.
PubMed 24378686
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight
- ClinicalTrials.gov ID
- NCT01040975
- Acronym / sponsor ID
- TeenCHAT / Pro00016206
- Conditions
- Communication, Obesity, Nutrition, Physical Activity, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Dec 2009 (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 teach primary care physicians effective ways to counsel overweight and obese adolescent patients to attain a healthy weight. Fifty physicians and up to 660 adolescent patients from Duke University Health System (DUHS) Primary Care Clinics will take part in this study.
Patients will be identified by research study staff and asked if they would be willing to have their clinic visit audio recorded for research purposes. There are three phases of data collection. First, baseline encounters (n=200, 4 per physician) are audio recorded. Then, half of the physicians will be randomized to receive a tailored web-based intervention containing information about evidence-based techniques to help adolescents attain a healthy weight. A new set of 200 encounters (4 per physician) will be audio recorded. Then, all physicians will receive a Summary Report that outlines the adolescent's high risk behaviors that contribute to weight (sweetened beverages, fast food, breakfast, physical activity, screen time, and sleep) and a new set of 200 encounters will be audio recorded.
Data will be collected by trained data technicians, in-person and over the phone. Data is collected on laptop computers and then downloaded into password protected electronic files on a secure network server. All participants (adolescent patients and physicians) will be assigned a code number that is the sole identifier on all study data forms. Prior to and after coding, digital files will be stored in password protected directories to which only the data technicians and project manager have access. The web-based intervention will be password protected.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing intervention | Experimental | Behavioral: Web-based intervention targeting MD communication; Summary ReportWeb-based intervention targeting MD communication and Summary Report |
| Control | No intervention | –MD receives Summary Report only |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Specialty is Family Practice or Pediatrics
- Located in participating clinic
- Not planning to leave clinic in the next two years
- English-speaking
- BMI z-score >85th percentile
Key exclusion criteria (6 listed)
- BMI z-score <85th percentile
- not English speaking
- pregnant
- <12 or older than 18
- incompetent for interview
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 |
|---|---|---|
| Web-based intervention targeting MD communication; Summary ReportAlso: Tailored Web-based intervention developed by study team, Tailored Summary ReportWeb-based intervention targeting MD communication; Summary Report detailing 6 risk factors for adolescent overweight/obesity developed by study team | Behavioural | Motivational Interviewing intervention |
Primary outcome
Physician communication
Time frame: after CD-ROM phase
2 secondary outcomes
Summary Report
Time frame: After Summary Report Phase
Adolescent Nutrition, Physical Activity, and BMI Z-score
Time frame: 3 months post-visit
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 23 Sep 2016.
- Derived from this study: PubMed 30115415Bodner ME, Lyna P, Ostbye T, Bravender T, Alexander SC, Tulsky JA, Lin PH, Pollak KI. Accuracy and congruence of physician and adolescent patient weight-related discussions: Teen CHAT (Communicating health: Analyzing talk). Patient Educ Couns. 2018 Dec;101(12):2105-2110. doi: 10.1016/j.pec.2018.07.022. Epub 2018 Jul 26.
- Derived from this study: PubMed 27228899Pollak KI, Tulsky JA, Bravender T, Ostbye T, Lyna P, Dolor RJ, Coffman CJ, Bilheimer A, Lin PH, Farrell D, Bodner ME, Alexander SC. Teaching primary care physicians the 5 A's for discussing weight with overweight and obese adolescents. Patient Educ Couns. 2016 Oct;99(10):1620-5. doi: 10.1016/j.pec.2016.05.007. Epub 2016 May 9.
- Derived from this study: PubMed 27155958Pollak KI, Coffman CJ, Tulsky JA, Alexander SC, Ostbye T, Farrell D, Lyna P, Dolor RJ, Bilheimer A, Lin PH, Bodner ME, Bravender TD. Teaching Physicians Motivational Interviewing for Discussing Weight With Overweight Adolescents. J Adolesc Health. 2016 Jul;59(1):96-103. doi: 10.1016/j.jadohealth.2016.03.026. Epub 2016 May 5.
- Derived from this study: PubMed 25575503Ostbye T, Lyna P, Bodner ME, Alexander SC, Coffman C, Tulsky JA, Dolor R, Pollak K. The Effect of Parental Presence on Weight-Related Discussions Between Physicians and Their Overweight Adolescent Patients. Clin Pediatr (Phila). 2015 Oct;54(12):1218-20. doi: 10.1177/0009922814566027. Epub 2015 Jan 9. No abstract available.
- Derived from this study: PubMed 24378686Alexander SC, Fortenberry JD, Pollak KI, Bravender T, Davis JK, Ostbye T, Tulsky JA, Dolor RJ, Shields CG. Sexuality talk during adolescent health maintenance visits. JAMA Pediatr. 2014 Feb;168(2):163-9. doi: 10.1001/jamapediatrics.2013.4338.
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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.
Kathryn I Pollak, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based intervention targeting MD communication; Summary Report in people with Communication and Obesity, run by Duke University 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 10 inclusion and 6 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 23 Sep 2016. 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?
Physician communication (time frame: after CD-ROM phase). 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 NCT01040975, 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 23 Sep 2016.