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Completed

NCT Number: NCT01569243

Text to Move (TTM)Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Connected Health, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Text messages

Other
  • 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

Usual Care

Other
  • 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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • McKesson Foundation

Registry information

Official study title

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

Acronym: TTM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 3, 2012
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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