PrediabetesADAPTNCT01473654
The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial
A study testing ADAPT tool in people with Prediabetes, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- ADAPT tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prediabetes
Who cannot join
- age<18
- diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
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
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.
Read the 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.
- Conditions
- Prediabetes
- Being tested
- ADAPT tool
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPT toolBehavioural
Also called ADAPT
Use of ADAPT shared goal setting tool in EMR
| Study group | Role | What they receive |
|---|---|---|
| ADAPT tool | Experimental | prediabetes counseling using ADAPT tool Receives: Behavioral: ADAPT tool |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
measured by pedometer
Measured: 6 months
Secondary outcomes (1)
hemoglobin a1c
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devin Mann, MD, MS, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473654
- Sponsor's protocol ID
- H-30397
- Other IDs
- 5K23DK081665
- Acronym
- ADAPT
- Status last verified
- Aug 2014
- First submitted
- 15 Nov 2011
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22269066
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01473654
- Acronym / sponsor ID
- ADAPT / H-30397
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADAPT tool | Experimental | Behavioral: ADAPT toolprediabetes counseling using ADAPT tool |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- prediabetes
Key exclusion criteria (2 listed)
- age<18
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAPT toolAlso: ADAPTUse of ADAPT shared goal setting tool in EMR | Behavioural | ADAPT tool |
Primary outcome
Physical Activity
Time frame: 6 months
measured by pedometer
1 secondary outcome
hemoglobin a1c
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Derived from this study: PubMed 22269066Mann 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.
Related trials for Prediabetes
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Recruiting
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Overweight , Obesity, Prediabetes
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Not yet recruitingEarly Phase 1
Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia
Hyperglycemias, Prediabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devin Mann, MD, MS principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT tool in people with Prediabetes, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01473654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014; AzTrials last refreshed its copy on 1 Nov 2026.