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

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ClinicalTrials.gov Identifier: NCT01473654
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : August 12, 2014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Boston University

Brief Summary:
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.

Condition or disease Intervention/treatment
Prediabetes Behavioral: ADAPT tool

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : November 2011
Primary Completion Date : April 2013
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ADAPT tool
prediabetes counseling using ADAPT tool
Behavioral: ADAPT tool
Use of ADAPT shared goal setting tool in EMR
Other Name: ADAPT
No Intervention: Control

Primary Outcome Measures :
  1. Physical Activity [ Time Frame: 6 months ]
    measured by pedometer

Secondary Outcome Measures :
  1. hemoglobin a1c [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • prediabetes

Exclusion Criteria:

  • age<18
  • diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473654

United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Boston University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Devin Mann, MD, MS Boston University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01473654     History of Changes
Other Study ID Numbers: H-30397
5K23DK081665 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases