Text to Move (TTM)Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using Activity Monitoring and Text Messaging For Behavior Change in a Diabetes Self-Management Program

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Text messages
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual care group<br>Subjects in this group will receive the usual standard of care available at MGH. | Other: Usual care<br>* 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).<br>* Other names: Control;|
| Experimental: Text messaging group<br>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<br>* 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.<br>* Other names: SMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity | Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Will be assessed by pre and post HbA1c measurements | over 6 months (Day 1 and day 180) | 
| 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. | 6 months | 
| Satisfaction with the program | This will be assessed using standardized Questionnaires at closeouts | 6 months | 
| 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Text messaging, Physical activity