Text to Move (TTM)Study (TTM)
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|ClinicalTrials.gov Identifier: NCT01569243|
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : February 6, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Other: Text messages Other: Usual care||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Using Activity Monitoring and Text Messaging For Behavior Change in a Diabetes Self-Management Program|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Usual care group
Subjects in this group will receive the usual standard of care available at MGH.
Other: Usual care
Other Name: Control
Experimental: Text messaging group
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.
Other: Text messages
Other Name: SMS
- physical activity [ Time Frame: 6 months ]Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.
- Clinical outcome [ Time Frame: over 6 months (Day 1 and day 180) ]Will be assessed by pre and post HbA1c measurements
- Change in physical activity behaviors [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]This will be assessed using standardized Questionnaires at closeouts
- Engagement to program [ Time Frame: 6 months ]
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
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): NCT01569243
|United States, Massachusetts|
|Center for Connected Health|
|Boston, Massachusetts, United States, 02114|
|Partners Healthcare Center for Connected Health|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Kamal Jethwani, MD, MPH||Center for Connected Health|