Text to Move (TTM)Study (TTM)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Text messages
Usual care
Sponsored by

About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Diabetes mellitus, Text messaging, Physical activity
Eligibility Criteria
Inclusion Criteria:
- Adults over the age of 18 years.
- HbA1c over 7.0%
- Patients with a diagnosis of T2DM at MGH Chelsea, MGH Revere MGH Charlestown or MGH Everett will be offered enrollment in the study.
- Must be willing to attend initial and close-out study visits
- Willingness to receive a maximum of 60 text messages/month for 6 months on their personal cellular phone.
- PC computer with internet access
- Fluency in English or Spanish (spoken and written)
Exclusion Criteria:
- Disability, medical or surgical condition preventing or precluding moderate physical activity.
- Significant cognitive deficits.
Sites / Locations
- Center for Connected Health
- Partners Healthcare Center for Connected Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Usual care group
Text messaging group
Arm Description
Subjects in this group will receive the usual standard of care available at MGH.
Subjects in this group will be enrolled to receive text messages aimed at providing bite-sized coaching based on measured step count to help improve activity levels and providing reminder, educational and motivation messages aimed at helping patients to meet their diabetes self-management goals.
Outcomes
Primary Outcome Measures
physical activity
Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.
Secondary Outcome Measures
Clinical outcome
Will be assessed by pre and post HbA1c measurements
Change in physical activity behaviors
This will be assessed by Pre and post stage of behavior change based on the Stages of Motivational Readiness for Change model of the TTM.
Satisfaction with the program
This will be assessed using standardized Questionnaires at closeouts
Engagement to program
This will be measure quantitatively by:
number of days participant wore their pedometers in the study;
number of logins to the ActiHealth step count web portal;
percentage of messages a user responds to, in 2-way text messages
Full Information
NCT ID
NCT01569243
First Posted
March 28, 2012
Last Updated
August 29, 2020
Sponsor
Massachusetts General Hospital
Collaborators
McKesson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01569243
Brief Title
Text to Move (TTM)Study
Acronym
TTM
Official Title
Using Activity Monitoring and Text Messaging For Behavior Change in a Diabetes Self-Management Program
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
McKesson Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a 2-arm randomized controlled trial examining the effect of personalized text messages on physical activity and clinical outcomes in patients with type 2 diabetes mellitus.
The investigators hypothesize that:
i. The use of personalized text messages will promote physical activity in patients with T2DM.
ii. Increased physical activity and behavior change correlate with better clinical outcomes (Change in HbA1c).
iii. The text messaging program will lead to sustained physical activity behavior change in patients with T2DM
Detailed Description
Patients are referred into a Diabetes Self-Management Education (DSME) Support Program at Massachusetts General Hospital by a primary care provider at the time of diagnosis or as needed to gain better knowledge, awareness and understanding of their disease. Majority of the patients in the DSME program experience favorable outcomes; however, in key areas of T2DM management such as physical activity and nutrition, fewer patients experience success with their behavior goals, owing to the higher level of motivation required, and our inability to provide more frequent individually tailored feedback and coaching. In addition, we have observed that patients' behavior change is not sustained over time after finishing the DSME program.
In the proposed study, the investigators intend to augment DSME's evidence-based approach with two key connected health cornerstones - objective data collection and targeted personalized feedback. Using these two tools, we hypothesize that patients will be able to acquire new behaviors much sooner than status quo, and also maintain them for longer. Also, the scalability of the mobile component of the innovation will help us offer this evidence-based program to a much larger pool of patients, contributing greatly to the overall quality of diabetes management at our hospital.
The research team at Center for Connected Health will recruit participants from a pool of patients with T2DM who are participating in or who have gone through the DSME program at MGH Chelsea, MGH Revere or MGH Charlestown. These practices represent the most medically under served areas and serve low-income population. All of these practices have received recognition from the American Diabetes Association as having high-quality diabetes self-management education programs that meet the National Standards for Diabetes Self-Management Education.
120 participants will be enrolled and randomly assigned to one of the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes mellitus, Text messaging, Physical activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care group
Arm Type
Other
Arm Description
Subjects in this group will receive the usual standard of care available at MGH.
Arm Title
Text messaging group
Arm Type
Experimental
Arm Description
Subjects in this group will be enrolled to receive text messages aimed at providing bite-sized coaching based on measured step count to help improve activity levels and providing reminder, educational and motivation messages aimed at helping patients to meet their diabetes self-management goals.
Intervention Type
Other
Intervention Name(s)
Text messages
Other Intervention Name(s)
SMS
Intervention Description
Participants will receive diabetic medical care as usual.
Participants will be given an ActiHealth pedometer to measure daily activity.
In addition, they will be enrolled to receive the study text messages.
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Control
Intervention Description
Participants will receive diabetic medical care as usual.
In addition, participants in the control group will be given an ActiHealth pedometer to measure daily activity (step counts will be used as a proxy for activity).
Primary Outcome Measure Information:
Title
physical activity
Description
Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical outcome
Description
Will be assessed by pre and post HbA1c measurements
Time Frame
over 6 months (Day 1 and day 180)
Title
Change in physical activity behaviors
Description
This will be assessed by Pre and post stage of behavior change based on the Stages of Motivational Readiness for Change model of the TTM.
Time Frame
6 months
Title
Satisfaction with the program
Description
This will be assessed using standardized Questionnaires at closeouts
Time Frame
6 months
Title
Engagement to program
Description
This will be measure quantitatively by:
number of days participant wore their pedometers in the study;
number of logins to the ActiHealth step count web portal;
percentage of messages a user responds to, in 2-way text messages
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults over the age of 18 years.
HbA1c over 7.0%
Patients with a diagnosis of T2DM at MGH Chelsea, MGH Revere MGH Charlestown or MGH Everett will be offered enrollment in the study.
Must be willing to attend initial and close-out study visits
Willingness to receive a maximum of 60 text messages/month for 6 months on their personal cellular phone.
PC computer with internet access
Fluency in English or Spanish (spoken and written)
Exclusion Criteria:
Disability, medical or surgical condition preventing or precluding moderate physical activity.
Significant cognitive deficits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal Jethwani, MD, MPH
Organizational Affiliation
Center for Connected Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Connected Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Partners Healthcare Center for Connected Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20712392
Citation
Gibson TB, Song X, Alemayehu B, Wang SS, Waddell JL, Bouchard JR, Forma F. Cost sharing, adherence, and health outcomes in patients with diabetes. Am J Manag Care. 2010 Aug;16(8):589-600.
Results Reference
background
PubMed Identifier
19118294
Citation
Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, Maryniuk M, Peyrot M, Piette JD, Reader D, Siminerio LM, Weinger K, Weiss MA. National standards for diabetes self-management education. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S87-94. doi: 10.2337/dc09-S087. No abstract available.
Results Reference
background
PubMed Identifier
19885247
Citation
Watson AJ, Grant RW, Bello H, Hoch DB. Brave new worlds: how virtual environments can augment traditional care in the management of diabetes. J Diabetes Sci Technol. 2008 Jul;2(4):697-702. doi: 10.1177/193229680800200422.
Results Reference
background
PubMed Identifier
18056885
Citation
Watson AJ, Bell AG, Kvedar JC, Grant RW. Reevaluating the digital divide: current lack of internet use is not a barrier to adoption of novel health information technology. Diabetes Care. 2008 Mar;31(3):433-5. doi: 10.2337/dc07-1667. Epub 2007 Dec 4. No abstract available.
Results Reference
background
PubMed Identifier
18296809
Citation
Jethwani KS, Chandwani HS. The internet: revolutionizing medical research for novices and virtuosos alike. J Postgrad Med. 2008 Jan-Mar;54(1):49-51. doi: 10.4103/0022-3859.39194. No abstract available.
Results Reference
background
PubMed Identifier
20144366
Citation
Watson AJ, Kvedar JC, Rahman B, Pelletier AC, Salber G, Grant RW. Diabetes connected health: a pilot study of a patient- and provider-shared glucose monitoring web application. J Diabetes Sci Technol. 2009 Mar 1;3(2):345-52. doi: 10.1177/193229680900300216.
Results Reference
background
PubMed Identifier
20508741
Citation
Kulshreshtha A, Kvedar JC, Goyal A, Halpern EF, Watson AJ. Use of remote monitoring to improve outcomes in patients with heart failure: a pilot trial. Int J Telemed Appl. 2010;2010:870959. doi: 10.1155/2010/870959. Epub 2010 May 19.
Results Reference
background
PubMed Identifier
20404229
Citation
Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29.
Results Reference
background
PubMed Identifier
28438728
Citation
Horner GN, Agboola S, Jethwani K, Tan-McGrory A, Lopez L. Designing Patient-Centered Text Messaging Interventions for Increasing Physical Activity Among Participants With Type 2 Diabetes: Qualitative Results From the Text to Move Intervention. JMIR Mhealth Uhealth. 2017 Apr 24;5(4):e54. doi: 10.2196/mhealth.6666.
Results Reference
derived
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