Movement Behaviours Among Bahraini Diabetics

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-75
SponsorRoyal College of Surgeons in Ireland - Medical University of Bahrain

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

340 Participants
are grouped into 1 trial group
Group A: Bahraini adults with type 2 diabetes

Trial outcomes

Primary outcomes

1

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.

Time frame
1 week (duration of the study)

Secondary outcomes

1

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.

Time frame
1 week (duration of the study)
2

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.

Time frame
Day 1/baseline
3

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.

Time frame
Day 1/baseline
4

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.

Time frame
Day 1/baseline

Other outcomes

Locations

4

Map coordinates are unavailable for these locations. Locations are shown below instead.

Isa Town Health CentreRecruitingBlock 743, Building 10, Road 43, ManamaBahrainBahrain
Ahmed Ali Kanoo Health CentreRecruitingBlock 626, Building 2009, Road 2641, ManamaBahrainBahrain
Halat Bu Maher Health CentreNot yet recruitingBlock 216, Building 2858, Road 1653, MuharraqBahrainBahrain
Shaikh Jaber AlSabah Health CentreNot yet recruitingBlock 518, Building 6347, Road Nakheel Street, Northern GovernorateBahrainBahrain

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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