About this trial
This observational study aims to measure movement behaviours and explore factors influencing these among Bahraini patients with type 2 diabetes.
The main objectives are:
(i) Measure free-living physical activity and sedentary behaviour with an accelerometer device (ii) Examine associations between movement behaviours and anthropometric and diabetes-related biochemical/clinical parameters (iii) Examine associations between movement behaviours and psychological and environmental determinants that influence movement behaviours (iv) Assess the feasibility and acceptability of the physical activity assessment tools as part of routine clinical practice with clinicians and diabetic patients
Participants will be invited to wear an accelerometer device for seven days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sex: Men and women are eligible.
Age: Individuals aged 20-75 years old are eligible.
Ethnicity: Bahraini adults of all ethnic groups are eligible for the study.
Type 2 diabetes and glycaemic control: Individuals with controlled type 2 diabetes (i.e. HbA1c <9 on medication) based on the medical record of each patient's last visit to the health centre for routine follow-up will be eligible if within the last four months. Otherwise, these measurements will be ordered at the first visit to confirm eligibility.
Disqualifiers
HbA1c >9%
Type 1 diabetes
Taking insulin
Pregnancy
Trial population
Bahraini adults of all ethnicities with controlled diabetes.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Movement behaviour
Movement behaviour will be assessed using a thigh-worn accelerometer (activPAL, PAL Technologies, Scotland, U.K. www.palt.com). It has no screen to indicate the amount of physical activity being done, so does not act as a motivational device. The activPAL will be used to collect data 24 hours/day over seven consecutive days.
Secondary outcomes
Activity diary
Participants will also be asked to keep an activity diary to record when they got up from and went to bed, took part in any activities, or when and why they removed the device.
Sociodemographic characteristics
Baseline data for age, gender, educational level, marital status, occupation, and type of living accommodation (or living arrangements) will be obtained by a self-administered questionnaire to describe the sample recruited at the start of the study.
Anthropometric parameters
Baseline data for body weight status and fat distribution will be established using the standard measurements of body mass index (BMI), waist circumference, and waist-to-hip ratio. Body Mass Index (BMI) will be calculated as weight divided by the square of the height (kg/m2). Standard categories of body weight status will be applied (underweight: \<18.50 kg/m2; normal weight: 18.50-24.99 kg/m2; overweight: 25.00-29.99 kg/m2; obese: ≥30.00 kg/m2). Waist circumference \>102 cm for men and \>88 cm for women will be classified as having abdominal obesity. Waist-to-hip ratios of ≥0.9 and ≥0.9 for men and ≥0.8 and ≥0.85 for women will be classified as overweight and obese, respectively.
Clinical parameters
Blood pressure, diabetes duration, smoking status, low-density lipoprotein (LDL), glycated haemoglobin (HbA1c), estimated glomerular filtration rate (e-GFR), and medication will be collected from the medical record of each patient's last visit to the health centre for routine follow-up if within the last four months. Otherwise, these parameters will be ordered at the first visit.
Locations
4Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
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Royal College of Surgeons in Ireland - Medical University of Bahrain
Lead sponsor
Ministry of Health, Bahrain
Collaborator
Arabian Gulf University, Bahrain
Collaborator
Royal College of Surgeons, Ireland
Collaborator