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

NCT ID: NCT06402578

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

At the point of consent the participants will be randomised to one of three allocated groups. Control group, Intervention 1 or Intervention 2.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

HbA1c testing

Intervention Type DIAGNOSTIC_TEST

Bloods will be take pre and post 12 week intervention.

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.

Group Type EXPERIMENTAL

HbA1c testing

Intervention Type DIAGNOSTIC_TEST

Bloods will be take pre and post 12 week intervention.

Interventions

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HbA1c testing

Bloods will be take pre and post 12 week intervention.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Margaret University

OTHER

Sponsor Role lead

Responsible Party

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Phil Calvert

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Calvert, MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student

Locations

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Queen Margret University Edinburgh

Edinburgh, Musselburgh, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Philip Calvert, MSc

Role: CONTACT

0131 474 0000

Derek Santos, PHD

Role: CONTACT

0131 474 0000

Other Identifiers

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QMU-IRAS ID: 327162

Identifier Type: -

Identifier Source: org_study_id

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