Clinical trial NCT01569243: Text to Move (TTM)Study
Official title: Using Activity Monitoring and Text Messaging For Behavior Change in a Diabetes Self-Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes mellitus
Text messaging
Physical activity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: McKesson Foundation
First posted: 2012-04-03
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: physical activity
timeFrame: 6 months
Secondary outcomes:
measure: Clinical outcome
timeFrame: over 6 months (Day 1 and day 180)
measure: Change in physical activity behaviors
timeFrame: 6 months
measure: Satisfaction with the program
timeFrame: 6 months
measure: Engagement to program
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Connected Health
state: Massachusetts
city: Boston
country: United States
facility: Partners Healthcare Center for Connected Health
state: Massachusetts
Study officials:
affiliation: Center for Connected Health
name: Kamal Jethwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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citation: 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.