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The Use of Short SMS Messaging With Type 2 Diabetes (T2DM) (mHealth)

Primary Purpose

Type 2 Diabetes, Physical Exercise

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
SMS Messaging
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinician diagnosis of T2DM.
  • Over 18 years of age.
  • Possession of a cell phone with text messaging capability.
  • Ability to read and understand Arabic.

Exclusion Criteria:

  • Treatment with insulin adjustment
  • Unable to understand the study requirements or give informed consent.
  • Visual impairment.
  • Any diabetes-related complications such as neuropathy or retinopathy that preclude ability to increase PA.
  • Clinician concern (physicians will be asked to confirm whether eligible participants can be medically capable of performing PA at the recommended level advised by National Institute for Health and Care Excellence (NICE, 2013).

Sites / Locations

  • King Fahd Medical City

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SMS Messages

Arm Description

Patients with type 2 diabetes will be recruited and will start receiving short SMS messages about physical activity, encouraging them to be more active and help them to build a healthy life style routine.

Outcomes

Primary Outcome Measures

Feasibility of mobile phone text messaging intervention for people with T2DM: Number of Participants recruited, completed the study, dropped out
Number of Participants recruited, completed the study, dropped out.

Secondary Outcome Measures

Acceptability of mobile phone text messaging intervention for people with T2DM: Qualitative interviews
Qualitative interviews will be undertaken with study participants and healthcare professionals (HCPs) to explore: satisfaction with the intervention; barriers and facilitators of the intervention; perceived impact of the intervention, and potential changes and necessary improvements.
Clinical measurements pre and after the intervention
Is glycated haemoglobin (HbA1c) sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM
Clinical measurements pre and after the intervention
Is the body mass index (BMI) in kg/m^2 sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM
Behaviour change outcome
Is self-efficacy for physical activity (SEPA) questionnaire sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM. The total score is calculated by finding the sum of the all items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Self-report questionnaire (International Physical Activity Questionnaire - IPAQ)
To compare levels of physical activity (PA) before and after an intervention, IPAQ is used to assess moderate-to-vigorous physical activity in adult people. Categorical Score- three levels of physical activity are proposed: Low • No activity is reported. Moderate More days of vigorous activity of at least 20 minutes per day. 3. High Vigorous-intensity activity on at least 3 days and accumulating at least 1500MET-minutes/week.

Full Information

First Posted
November 19, 2019
Last Updated
August 26, 2021
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT04243174
Brief Title
The Use of Short SMS Messaging With Type 2 Diabetes (T2DM)
Acronym
mHealth
Official Title
The Use of Mobile Phone Messaging as a Behavioural Intervention to Increase Physical Activity in Adults With T2DM in Saudi Arabia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Physical activity (PA) can play a vital and an independent role in type 2 diabetes (T2DM) management care. Health research studies have shown evidence that PA can improve glycaemic control and glucose levels. PA is first line of self-care management recommended to patients with T2DM and most patients fail to perform the regular PA. It is always important for health providers to find better methods in encouraging and incentivizing PA in T2DM patients. Mobile phone messaging-based interventions have been shown to strengthen the delivery of health information and self-care management programs.
Detailed Description
Studies have employed this as a tool for promoting T2DM self-care management interventions such as physical activity, glucose monitoring, medication adherence and nutrition. Despite the increasing number of these interventions globally, the effectiveness of mobile phone messaging-based interventions in Saudi Arabia context remains inconclusive and inconsistent. There is limited research conducted in this region. Therefore, there is a need for more studies to show evidence to ascertain the effectiveness of using mobile phone messaging to promote PA in T2DM patients in the context of Saudi Arabia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Physical Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group where they start receiving SMS messages about the importance of physical activity and its benefits on T2DM.
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS Messages
Arm Type
Other
Arm Description
Patients with type 2 diabetes will be recruited and will start receiving short SMS messages about physical activity, encouraging them to be more active and help them to build a healthy life style routine.
Intervention Type
Behavioral
Intervention Name(s)
SMS Messaging
Intervention Description
Patients with type 2 diabetes will be recruited and will start receiving short SMS messages about physical activity, encouraging them to be more active and help them to build a healthy life style routine.
Primary Outcome Measure Information:
Title
Feasibility of mobile phone text messaging intervention for people with T2DM: Number of Participants recruited, completed the study, dropped out
Description
Number of Participants recruited, completed the study, dropped out.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Acceptability of mobile phone text messaging intervention for people with T2DM: Qualitative interviews
Description
Qualitative interviews will be undertaken with study participants and healthcare professionals (HCPs) to explore: satisfaction with the intervention; barriers and facilitators of the intervention; perceived impact of the intervention, and potential changes and necessary improvements.
Time Frame
Six weeks
Title
Clinical measurements pre and after the intervention
Description
Is glycated haemoglobin (HbA1c) sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM
Time Frame
3 months
Title
Clinical measurements pre and after the intervention
Description
Is the body mass index (BMI) in kg/m^2 sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM
Time Frame
3 months
Title
Behaviour change outcome
Description
Is self-efficacy for physical activity (SEPA) questionnaire sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM. The total score is calculated by finding the sum of the all items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Time Frame
Six weeks
Title
Self-report questionnaire (International Physical Activity Questionnaire - IPAQ)
Description
To compare levels of physical activity (PA) before and after an intervention, IPAQ is used to assess moderate-to-vigorous physical activity in adult people. Categorical Score- three levels of physical activity are proposed: Low • No activity is reported. Moderate More days of vigorous activity of at least 20 minutes per day. 3. High Vigorous-intensity activity on at least 3 days and accumulating at least 1500MET-minutes/week.
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinician diagnosis of T2DM. Over 18 years of age. Possession of a cell phone with text messaging capability. Ability to read and understand Arabic. Exclusion Criteria: Treatment with insulin adjustment Unable to understand the study requirements or give informed consent. Visual impairment. Any diabetes-related complications such as neuropathy or retinopathy that preclude ability to increase PA. Clinician concern (physicians will be asked to confirm whether eligible participants can be medically capable of performing PA at the recommended level advised by National Institute for Health and Care Excellence (NICE, 2013).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Holly Blake, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Fahd Medical City
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study has been conducted and completed.
IPD Sharing Time Frame
01-06-2020

Learn more about this trial

The Use of Short SMS Messaging With Type 2 Diabetes (T2DM)

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