NCT04243174

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

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

November 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

November 19, 2019

Last Update Submit

August 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Six weeks

Secondary Outcomes (5)

  • Acceptability of mobile phone text messaging intervention for people with T2DM: Qualitative interviews

    Six weeks

  • Clinical measurements pre and after the intervention

    3 months

  • Clinical measurements pre and after the intervention

    3 months

  • Behaviour change outcome

    Six weeks

  • Self-report questionnaire (International Physical Activity Questionnaire - IPAQ)

    Six weeks

Study Arms (1)

SMS Messages

OTHER

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

Interventions

SMS MessagingBEHAVIORAL

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.

SMS Messages

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Fahd Medical City

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Dr.Holly Blake, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single Group where they start receiving SMS messages about the importance of physical activity and its benefits on T2DM.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 19, 2019

First Posted

January 28, 2020

Study Start

January 23, 2020

Primary Completion

March 1, 2020

Study Completion

March 30, 2020

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

After the study has been conducted and completed.

Shared Documents
STUDY PROTOCOL
Time Frame
01-06-2020

Locations