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

NCT06402578 | Not Yet Recruiting

• 1 other identifier: QMU-IRAS ID: 327162
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

HbA1c; Cholesterol; Resting Heart Rate

Outcome Measures

Primary Outcomes (1)

• HbA1c testing

  blood will be take pre and post trial.

  12 weeks

Secondary Outcomes (1)

• Cholesterol ratio testing

  12 weeks

Study Arms (3)

Control Group,

NO INTERVENTION

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.

Intervention 1

EXPERIMENTAL

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

Intervention 2

EXPERIMENTAL

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

Interventions

HbA1c testing DIAGNOSTIC_TEST

Bloods will be take pre and post 12 week intervention.

Intervention 1; Intervention 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Margaret University: lead

Study Sites (1)

Queen Margret University Edinburgh

Edinburgh, Musselburgh, EH21 6UU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Philip Calvert, MSc

  PhD student

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Calvert, MSc

CONTACT

0131 474 0000; PCalvert@qmu.ac.uk

Derek Santos, PHD

CONTACT

0131 474 0000; DSantos@qmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: At the point of consent the participants will be randomised to one of three allocated groups. Control group, Intervention 1 or Intervention 2.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: May 7, 2024
• Study Start: June 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

GB (1)