Text to Move (TTM)Study (TTM)

August 29, 2020 updated by: Joseph C. Kvedar, Massachusetts General Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Center for Connected Health
      • Boston, Massachusetts, United States, 02114
        • Partners Healthcare Center for Connected Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • 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 Names:
  • SMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

McKesson Foundation

Investigators

  • Principal Investigator: Kamal Jethwani, MD, MPH, Center for Connected Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 29, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-P-002708/1; MGH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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