- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center - Cancer Prevention, Detection and Control
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Motivational Interviewing intervention
Web-based intervention targeting MD communication and Summary Report
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Web-based intervention targeting MD communication; Summary Report detailing 6 risk factors for adolescent overweight/obesity developed by study team
Outros nomes:
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Sem intervenção: Control
MD receives Summary Report only
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Physician communication
Prazo: after CD-ROM phase
|
after CD-ROM phase
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Summary Report
Prazo: After Summary Report Phase
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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
Prazo: 3 months post-visit
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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.
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3 months post-visit
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kathryn I Pollak, PhD, Duke University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- Pro00016206
- 1R01HL092403-01A2 (Concessão/Contrato do NIH dos EUA)
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