A 12-week Digital Physical Activity Programme, With or Without Physical Education Support for Type 2 Diabetes Patients.

May 3, 2024 updated by: Phil Calvert, Queen Margaret University

A Feasibility Randomised Controlled Trial to Investigate the Effects of a 12-week Digital Physical Activity Programme, With or Without Physical Education Support, on Blood Glucose Control in Patients With Type 2 Diabetes Mellitus

Investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary objective: investigate the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing. Secondary objective: evaluate the effects on Cholesterol (ratio of High Density Lipids to Low Density Lipids), Resting Heart Rate, and Body Mass Index after a 12 week physical activity programme. Monitor step counts and sleep patterns during a 12 week physical activity programme.: Methods: Using a RCT is intended to implement dependent variable inductive research into a 12-week e-Health Physical activity (PA) programme with or without physical education support focusing on the blood glucose control in patients with T2DM. Recruitment of 60 patients from hospital out-patient clinics, community diabetic departments, and. NHS patients from general practitioners.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Musselburgh
      • Edinburgh, Musselburgh, United Kingdom, EH21 6UU
        • Queen Margret University Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • A diagnosis of T2DM in the last 3 years.
  • Age 18+ years.
  • Uses the English language as a primary or secondary language with the ability to read and write.
  • Lives in the United Kingdom.
  • Has no medical reason preventing participation in regular physical activity.
  • Has a SMART phone with access to the internet.

Exclusion Criteria:

  • Physical inability to participate in 12 weeks of physical activity.
  • Cardiac or cardiovascular surgery in the past 6 months.
  • Musculoskeletal issues that could be aggravated whilst participating in regular physical activity.
  • Presently participating in a weight loss programme.
  • Unable to commit to the 12-week feasibility study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group,
Control Group, will be issued with a smartwatch that is paired with a freely accessible App called Alexia® to record their PA. They will be asked to carry on with their daily activity and to record when they do any of their own physical activities that they do themselves routinely on an everyday basis during the 12 week study. They will not receive a 12 week PA programme.
Experimental: Intervention 1
Intervention 1, will be provided with a 12 week PA programme and asked to record their PA while they follow the programme during the 12 week study.
Diagnostic test: HbA1c testing
Bloods will be take pre and post 12 week intervention.
Experimental: Intervention 2
Intervention 2, will also be provided with the same 12 week PA program and asked to record their PA while they follow the programme during the 12 week study. The participants in this group will also get support from a physical activity professional (PAP) who will be monitoring their 12 week journey. The PAP will be prompting the participant with weekly information as to why they are doing these exercises as well as supporting the participants to continue their programme as soon as non-adherence to the exercise program becomes apparent during the 12 week study.
Diagnostic test: HbA1c testing
Bloods will be take pre and post 12 week intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c testing
Time Frame: 12 weeks
blood will be take pre and post trial.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol ratio testing
Time Frame: 12 weeks
blood will be take pre and post trial.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Margaret University

Investigators

  • Principal Investigator: Philip Calvert, MSc, PhD student

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QMU-IRAS ID: 327162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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