- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01040975
Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight (TeenCHAT)
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center - Cancer Prevention, Detection and Control
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria for MDs:
- Specialty is Family Practice or Pediatrics
- Located in participating clinic
- Not planning to leave clinic in the next two years
Inclusion Criteria for teen patients:
- English-speaking
- BMI z-score >85th percentile
- age 12-18
- not pregnant
- have parental consent to participate if over 18
- have visit at least 7 days in the future
- have access to a telephone
Exclusion Criteria for teen patients:
- BMI z-score <85th percentile
- not English speaking
- pregnant
- <12 or older than 18
- incompetent for interview
- seen primarily by non-physician provider
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Motivational Interviewing intervention
Web-based intervention targeting MD communication and Summary Report
|
Web-based intervention targeting MD communication; Summary Report detailing 6 risk factors for adolescent overweight/obesity developed by study team
Andre navn:
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Ingen inngripen: Control
MD receives Summary Report only
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Physician communication
Tidsramme: after CD-ROM phase
|
after CD-ROM phase
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Summary Report
Tidsramme: After Summary Report Phase
|
Assess whether summary report increases whether physicians address six health risk behaviors
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After Summary Report Phase
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Adolescent Nutrition, Physical Activity, and BMI Z-score
Tidsramme: 3 months post-visit
|
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.
|
3 months post-visit
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kathryn I Pollak, PhD, Duke University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Pollak 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.
- Pollak 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.
- Ostbye 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.
- Alexander 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Pro00016206
- 1R01HL092403-01A2 (U.S. NIH-stipend/kontrakt)
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