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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243174
Recruitment Status : Completed
First Posted : January 28, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Holly Blake, University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Physical Exercise Behavioral: SMS Messaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: The Use of Mobile Phone Messaging as a Behavioural Intervention to Increase Physical Activity in Adults With T2DM in Saudi Arabia
Actual Study Start Date : January 23, 2020
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SMS Messages
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.
Behavioral: SMS Messaging
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 Measures :
  1. Feasibility of mobile phone text messaging intervention for people with T2DM: Number of Participants recruited, completed the study, dropped out [ Time Frame: Six weeks ]
    Number of Participants recruited, completed the study, dropped out.


Secondary Outcome Measures :
  1. Acceptability of mobile phone text messaging intervention for people with T2DM: Qualitative interviews [ Time Frame: Six weeks ]
    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.

  2. Clinical measurements pre and after the intervention [ Time Frame: 3 months ]
    Is glycated haemoglobin (HbA1c) sensitive to change when using SMS text messaging for physical activity promotion in the care of T2DM

  3. Clinical measurements pre and after the intervention [ Time Frame: 3 months ]
    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

  4. Behaviour change outcome [ Time Frame: Six weeks ]
    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.

  5. Self-report questionnaire (International Physical Activity Questionnaire - IPAQ) [ Time Frame: Six weeks ]

    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:

    1. Low

      • No activity is reported.

    2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243174


Locations
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Saudi Arabia
King Fahd Medical City
Riyadh, Saudi Arabia
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Dr.Holly Blake, PhD University of Nottingham
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Responsible Party: Holly Blake, Associate Professor, University of Nottingham
ClinicalTrials.gov Identifier: NCT04243174    
Other Study ID Numbers: 10
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study has been conducted and completed.
Supporting Materials: Study Protocol
Time Frame: 01-06-2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases