NCT01569243

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2012

Typical duration for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

March 28, 2012

Last Update Submit

August 29, 2020

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitusText messagingPhysical activity

Outcome Measures

Primary Outcomes (1)

  • physical activity

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

    6 months

Secondary Outcomes (4)

  • Clinical outcome

    over 6 months (Day 1 and day 180)

  • Change in physical activity behaviors

    6 months

  • Satisfaction with the program

    6 months

  • Engagement to program

    6 months

Study Arms (2)

Usual care group

OTHER

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

Other: Usual care

Text messaging group

EXPERIMENTAL

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

Interventions

Text messagesOTHER

* 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.

Also known as: SMS
Text messaging group
Usual careOTHER

* 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).

Also known as: Control
Usual care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Connected Health

Boston, Massachusetts, 02114, United States

Location

Partners Healthcare Center for Connected Health

Boston, Massachusetts, 02114, United States

Location

Related Publications (9)

  • 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.

    PMID: 20712392BACKGROUND

  • 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.

    PMID: 19118294BACKGROUND

  • 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.

    PMID: 19885247BACKGROUND

  • 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.

    PMID: 18056885BACKGROUND

  • 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.

    PMID: 18296809BACKGROUND

  • 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.

    PMID: 20144366BACKGROUND

  • 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.

    PMID: 20508741BACKGROUND

  • 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.

    PMID: 20404229BACKGROUND

  • 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.

    PMID: 28438728DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Kamal Jethwani, MD, MPH

    Center for Connected Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist

Study Record Dates

First Submitted

March 28, 2012

First Posted

April 3, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations

US(2)