NCT01473654

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration 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

November 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

November 15, 2011

Last Update Submit

August 11, 2014

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    measured by pedometer

    6 months

Secondary Outcomes (1)

  • hemoglobin a1c

    6 months

Study Arms (2)

ADAPT tool

EXPERIMENTAL

prediabetes counseling using ADAPT tool

Behavioral: ADAPT tool

Control

NO INTERVENTION

Interventions

ADAPT toolBEHAVIORAL

Use of ADAPT shared goal setting tool in EMR

Also known as: ADAPT
ADAPT tool

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • prediabetes

You may not qualify if:

  • age\<18
  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

    PMID: 22269066DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Devin Mann, MD, MS

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 17, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2014

Last Updated

August 12, 2014

Record last verified: 2014-08

Locations

US(1)