NCT01040975

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

4.3 years

First QC Date

December 29, 2009

Last Update Submit

September 22, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physician communication

    after CD-ROM phase

Secondary Outcomes (2)

  • Summary Report

    After Summary Report Phase

  • Adolescent Nutrition, Physical Activity, and BMI Z-score

    3 months post-visit

Study Arms (2)

Motivational Interviewing intervention

EXPERIMENTAL

Web-based intervention targeting MD communication and Summary Report

Behavioral: Web-based intervention targeting MD communication; Summary Report

Control

NO INTERVENTION

MD receives Summary Report only

Interventions

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

Also known as: Tailored Web-based intervention developed by study team, Tailored Summary Report
Motivational Interviewing intervention

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • not pregnant
  • have parental consent to participate if over 18
  • have visit at least 7 days in the future
  • have access to a telephone

You may not qualify if:

  • BMI z-score \<85th percentile
  • not English speaking
  • pregnant
  • \<12 or older than 18
  • incompetent for interview
  • seen primarily by non-physician provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center - Cancer Prevention, Detection and Control

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

  • 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.

MeSH Terms

Conditions

CommunicationObesityMotor Activity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kathryn I Pollak, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2009

First Posted

December 30, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations