Text to Move (TTM)Study

NCT ID: NCT01569243

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-10-31

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

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual care group

Subjects in this group will receive the usual standard of care available at MGH.

Group Type: OTHER

Usual care

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

Text messages

Intervention Type: 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.

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Other Intervention Names

SMS; Control

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McKesson Foundation

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph C. Kvedar

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamal Jethwani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Center for Connected Health

Locations

Center for Connected Health

Boston, Massachusetts, United States

Partners Healthcare Center for Connected Health

Boston, Massachusetts, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20404229 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28438728 (View on PubMed)

Other Identifiers

2011-P-002708/1; MGH

Identifier Type: -

Identifier Source: org_study_id