The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial (ADAPT)
Primary Purpose
Prediabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADAPT tool
Sponsored by
About this trial
This is an interventional health services research trial for Prediabetes
Eligibility Criteria
Inclusion Criteria:
- prediabetes
Exclusion Criteria:
- age<18
- diabetes
Sites / Locations
- Mount Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ADAPT tool
Control
Arm Description
prediabetes counseling using ADAPT tool
Outcomes
Primary Outcome Measures
Physical Activity
measured by pedometer
Secondary Outcome Measures
hemoglobin a1c
Full Information
NCT ID
NCT01473654
First Posted
November 15, 2011
Last Updated
August 11, 2014
Sponsor
Boston University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01473654
Brief Title
The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial
Acronym
ADAPT
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADAPT tool
Arm Type
Experimental
Arm Description
prediabetes counseling using ADAPT tool
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
ADAPT tool
Other Intervention Name(s)
ADAPT
Intervention Description
Use of ADAPT shared goal setting tool in EMR
Primary Outcome Measure Information:
Title
Physical Activity
Description
measured by pedometer
Time Frame
6 months
Secondary Outcome Measure Information:
Title
hemoglobin a1c
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
prediabetes
Exclusion Criteria:
age<18
diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devin Mann, MD, MS
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22269066
Citation
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.
Results Reference
derived
Learn more about this trial
The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial
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