Clinical trial NCT06402578: A 12-week Digital Physical Activity Programme, With or Without Physical Education Support for Type 2 Diabetes Patients.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: HbA1c
Cholesterol
Resting Heart Rate
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the point of consent the participants will be randomised to one of three allocated groups. Control group, Intervention 1 or Intervention 2.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c testing
timeFrame: 12 weeks
Secondary outcomes:
measure: Cholesterol ratio testing
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Queen Margret University Edinburgh
state: Musselburgh
Study officials:
affiliation: PhD student
name: Philip Calvert, MSc
role: PRINCIPAL_INVESTIGATOR
References: