NCT03167866

Brief Summary

The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will be randomized to two groups, the control group gets informational text message and the intervention group gets motivational SMS. The patients get a weekly text message and after 26 weeks the HbA1c and quality of life will be assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

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

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

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

April 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

April 26, 2017

Last Update Submit

May 24, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c levels at 6 months from beginning of messages

    Blood HbA1c levels are reflective of how well diabetes is controlled

    at 6 months from beginning of study

Secondary Outcomes (1)

  • Diabetes Quality of Life questionnaire

    at 6 months from beginning of study

Study Arms (2)

control group

PLACEBO COMPARATOR

DM patients who receive a weekly informational Short Message Service (SMS) by phone for 26 weeks. informational SMS

Behavioral: informational SMS

test group

EXPERIMENTAL

DM patients who receive a weekly motivational Short Message Service (SMS) for 26 weeks. motivational SMS

Behavioral: motivational SMS

Interventions

motivational SMSBEHAVIORAL

the participant receives a weekly text message that is aimed to increase motivation

test group
informational SMSBEHAVIORAL

the participant a weekly text message that is provides information on improving lifestyle

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncontrolled DM 2 patients (HbA1c \> 8%)
  • Know to read (Hebrew or Arabic)
  • Have a cellular phone
  • Can sign informed consent.

You may not qualify if:

  • A life expectancy of less than one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

Related Publications (5)

  • Text message program improves outcomes, decreases ED utilization among ED patients with poorly controlled diabetes. ED Manag. 2014 Feb;26(2):20-3.

    PMID: 24505864BACKGROUND

  • Reinhardt JA, van der Ploeg HP, Grzegrzulka R, Timperley JG. lmplementing lifestyle change through phone-based motivational interviewing in rural-based women with previous gestational diabetes mellitus. Health Promot J Austr. 2012 Apr;23(1):5-9. doi: 10.1071/he12005.

    PMID: 22730940BACKGROUND

  • Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.

    PMID: 22524591BACKGROUND

  • Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. No abstract available.

    PMID: 26822328BACKGROUND

  • Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.

    PMID: 24622367BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Irit Hochberg, MD/PhD

    Rambam Healthcare Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irit Hochberg, MD/PhD

CONTACT

972-4-7772150i_hochberg@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Randomization will be by study personell that is not in contact with participants
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 30, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)