AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 2TTMNCT01569243

Text to Move (TTM)Study

A Phase 2 study testing Text messages in people with Type 2 Diabetes Mellitus, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Text messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesUnited States
Study dates
Jun 2012to Oct 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Disability, medical or surgical condition preventing or precluding moderate physical activity.
  • Significant cognitive deficits.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Center for Connected Health

    Boston, Massachusetts, 02114

  • Partners Healthcare Center for Connected Health

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: 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:

  1. 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
Read the 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.

Being tested
Text messages, Usual care
Keywords
Diabetes mellitus, Text messaging, Physical activity
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Text messagesOther

    Also called SMS

    • 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.

  • Usual careOther

    Also called Control

    • 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).
Study groups in NCT01569243
Study groupRoleWhat they receive
Usual care groupOtherSubjects in this group will receive the usual standard of care available at MGH.
Receives: Other: Usual care
Text messaging groupExperimentalSubjects 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.
Receives: Other: Text messages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. physical activity

    Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.

    Measured: 6 months

Secondary outcomes (4)

  1. Clinical outcome

    Will be assessed by pre and post HbA1c measurements

    Measured: over 6 months (Day 1 and day 180)

  2. 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.

    Measured: 6 months

  3. Satisfaction with the program

    This will be assessed using standardized Questionnaires at closeouts

    Measured: 6 months

  4. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01569243
Sponsor's protocol ID
2011-P-002708/1; MGH
Acronym
TTM
Status last verified
Aug 2020
First submitted
28 Mar 2012
Last updated
1 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • Gibson TB, Song X, Alemayehu B, Wang SS, Waddell JL, Bouchard JR, Forma F. Cost sharing, adherence, and health outcomes in patients with diabetes. Am J Manag Care. 2010 Aug;16(8):589-600.

    PubMed 20712392

  • Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, Maryniuk M, Peyrot M, Piette JD, Reader D, Siminerio LM, Weinger K, Weiss MA. National standards for diabetes self-management education. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S87-94. doi: 10.2337/dc09-S087. No abstract available.

    PubMed 19118294

  • Watson AJ, Grant RW, Bello H, Hoch DB. Brave new worlds: how virtual environments can augment traditional care in the management of diabetes. J Diabetes Sci Technol. 2008 Jul;2(4):697-702. doi: 10.1177/193229680800200422.

    PubMed 19885247

  • Watson AJ, Bell AG, Kvedar JC, Grant RW. Reevaluating the digital divide: current lack of internet use is not a barrier to adoption of novel health information technology. Diabetes Care. 2008 Mar;31(3):433-5. doi: 10.2337/dc07-1667. Epub 2007 Dec 4. No abstract available.

    PubMed 18056885

  • Jethwani KS, Chandwani HS. The internet: revolutionizing medical research for novices and virtuosos alike. J Postgrad Med. 2008 Jan-Mar;54(1):49-51. doi: 10.4103/0022-3859.39194. No abstract available.

    PubMed 18296809

  • Watson AJ, Kvedar JC, Rahman B, Pelletier AC, Salber G, Grant RW. Diabetes connected health: a pilot study of a patient- and provider-shared glucose monitoring web application. J Diabetes Sci Technol. 2009 Mar 1;3(2):345-52. doi: 10.1177/193229680900300216.

    PubMed 20144366

  • Kulshreshtha A, Kvedar JC, Goyal A, Halpern EF, Watson AJ. Use of remote monitoring to improve outcomes in patients with heart failure: a pilot trial. Int J Telemed Appl. 2010;2010:870959. doi: 10.1155/2010/870959. Epub 2010 May 19.

    PubMed 20508741

  • Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29.

    PubMed 20404229

  • Horner GN, Agboola S, Jethwani K, Tan-McGrory A, Lopez L. Designing Patient-Centered Text Messaging Interventions for Increasing Physical Activity Among Participants With Type 2 Diabetes: Qualitative Results From the Text to Move Intervention. JMIR Mhealth Uhealth. 2017 Apr 24;5(4):e54. doi: 10.2196/mhealth.6666.

    PubMed 28438728

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Text messages in people with Type 2 Diabetes Mellitus, run by Massachusetts General Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

physical activity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01569243, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Text to Move (TTM)Study (NCT01569243) | AzTrials