Skip to main content
OpenTrials
Completed

NCT Number: NCT04243174

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Physical Exercise

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Fahd Medical City

Riyadh, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

SMS messaging

Behavioral

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 outcomes

  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 outcomes

  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:

    • Low
    • No activity is reported.
    • Moderate
    • More days of vigorous activity of at least 20 minutes per day.
    • High
    • Vigorous-intensity activity on at least 3 days and accumulating at least 1500MET-minutes/week.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

The Use of Mobile Phone Messaging as a Behavioural Intervention to Increase Physical Activity in Adults With T2DM in Saudi Arabia

Acronym: mHealth

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.