The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial (ADAPT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01473654
First received: November 15, 2011
Last updated: August 11, 2014
Last verified: August 2014

November 15, 2011
August 11, 2014
November 2011
April 2013   (final data collection date for primary outcome measure)
Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
measured by pedometer
Same as current
Complete list of historical versions of study NCT01473654 on ClinicalTrials.gov Archive Site
hemoglobin a1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial
Avoiding Diabetes Thru Action Plan Targeting (ADAPT): A Pilot Randomized Control Trial of an Electronic Medical Record Embedded Prediabetes Shared Goal Setting Tool in Primary Care

The goal of this randomized control trial is to study the impact of an electronic health record embedded tool's ability to facilitate shared provider-patient goal setting to promote lifestyle behavior change and prevent diabetes in primary care.

The ADAPT (Avoiding Diabetes Thru Action Plan Targeting) trial is an innovative study that leverages persuasive technology to enhance the lifestyle behavior change counseling efficacy of primary care providers. Using principles of behavior change theory and persuasion technology, the multidisciplinary design team utilized in-depth interviews and in-vivo usability testing to produce a prototype diabetes prevention counseling system embedded in the electronic health record. The core element of the tool is a streamlined shared goal setting module within the electronic health record system. The system also utilizes a pre-encounter patient behavior change goals elicitation survey to help tailor the goal setting session to patient preferences and encourage shared decision making. The patients also interact with a website that collects their longitudinal behavior change data and visualizes their progress over time and in comparison to other study members. The ADAPT system utilizes the influential powers of goal setting, tailoring, reminders, social comparisons, testimonials and other methods to integrate evidence based behavior change principles and persuasion techniques into routine primary care clinical encounters. If successful, the ADAPT system may represent an adaptable and scalable technology-enabled behavior change tool for all primary care providers.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Prediabetes
Behavioral: ADAPT tool
Use of ADAPT shared goal setting tool in EMR
Other Name: ADAPT
  • Experimental: ADAPT tool
    prediabetes counseling using ADAPT tool
    Intervention: Behavioral: ADAPT tool
  • No Intervention: Control
Mann DM, Lin JJ. Increasing efficacy of primary care-based counseling for diabetes prevention: rationale and design of the ADAPT (Avoiding Diabetes Thru Action Plan Targeting) trial. Implement Sci. 2012 Jan 23;7:6. doi: 10.1186/1748-5908-7-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2014
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • prediabetes

Exclusion Criteria:

  • age<18
  • diabetes
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01473654
H-30397, 5K23DK081665
No
Boston University
Boston University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Devin Mann, MD, MS Boston University
Boston University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP