Text to Move (TTM)Study (TTM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01569243
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : February 6, 2014
McKesson Foundation
Information provided by (Responsible Party):
Kamal Jethwani, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Text messages Other: Usual care Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Usual care group
Subjects in this group will receive the usual standard of care available at MGH.
Other: Usual care
  • 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).
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
  • 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.
Other Name: SMS

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Clinical outcome [ Time Frame: over 6 months (Day 1 and day 180) ]
    Will be assessed by pre and post HbA1c measurements

  2. 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.

  3. Satisfaction with the program [ Time Frame: 6 months ]
    This will be assessed using standardized Questionnaires at closeouts

  4. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Massachusetts General Hospital
McKesson Foundation
Principal Investigator: Kamal Jethwani, MD, MPH Center for Connected Health


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kamal Jethwani, Lead Research Scientist, Massachusetts General Hospital Identifier: NCT01569243     History of Changes
Other Study ID Numbers: 2011-P-002708/1; MGH
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014

Keywords provided by Kamal Jethwani, Massachusetts General Hospital:
Diabetes mellitus
Text messaging
Physical activity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases