Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight

Obesity Clinical Trial

— TeenCHAT  

Official title:

Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040975
• Other study ID #: Pro00016206
• Secondary ID: 1R01HL092403-01A
• Status: Completed
• Phase: N/A
• First received: December 29, 2009
• Last updated: September 22, 2016
• Start date: September 2009
• Est. completion date: February 2014

Study information

• Verified date: September 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Communication
• Nutrition
• Obesity
• Physical Activity
• Sleep

Intervention

Behavioral:
• Web-based intervention targeting MD communication; Summary Report
Web-based intervention targeting MD communication; Summary Report detailing 6 risk factors for adolescent overweight/obesity developed by study team

Locations

Country	Name	City	State
United States	Duke University Medical Center - Cancer Prevention, Detection and Control	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician communication		after CD-ROM phase	No
Secondary	Summary Report	Assess whether summary report increases whether physicians address six health risk behaviors	After Summary Report Phase	No
Secondary	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.	3 months post-visit	No