Movement Behaviours Among Bahraini Diabetics

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Movement Behaviours Among Bahraini Type 2 Diabetic Adults: a Cross-sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06069258
• Other study ID #: 284/23-Oct-222
• Status: Not yet recruiting
• Start date: October 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Royal College of Surgeons in Ireland - Medical University of Bahrain
• Contact: Ebrahim Rajab, PhD
• Phone: 16660122
• Email: erajab[@]rcsi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

In Bahrain, the number of people diagnosed with diabetes has risen from 9% at the start of the new millennium to 15% in 2022, and like any other country, it places a significant burden on the country's health system. People with type 2 diabetes mellitus (T2DM) are more sedentary, do less physical activity (PA), have lower cardiovascular fitness levels and are at higher risk for comorbid conditions that may affect mobility (e.g., sarcopenia and diabetic foot ulcers) compared to people without diabetes. Regular aerobic physical activity benefits in this clinical population include reduced HbA1C, triglycerides, blood pressure, body fat, and insulin resistance. Understanding the PA and sedentary behaviour patterns of Bahraini adults with T2DM is an essential first step towards our long-term goal of planning and developing a physical activity intervention.

A combination of self-efficacy and outcome expectations influence behaviour change, and it is important to understand the relationship between these in any specific T2DM population to identify appropriate interventions. Improving uptake and adherence to PA by people with T2DM also requires an understanding of any enablers and barriers.

This study aims to measure movement behaviours among Bahraini adult patients with T2DM using an accelerometer device and to examine associations with anthropometric and biochemical/clinical parameters, psychological and environmental determinants that influence these behaviours, and to assess the feasibility and acceptability of the PA assessment tools as part of standard clinical practice with clinicians and people with diabetes.

The study design will be observational and conducted at four specialist government diabetic clinics drawn from across the governorates of Bahrain. We aim to recruit 320 Bahraini adults 45-64 years old with controlled T2DM.

Participants will attend two visits seven days apart:

Visit 1: Anthropometric measurements will be conducted. information on sociodemographic characteristics will be collected. Information on select clinical parameters will be collected from the medical record of each patient's last visit to the health centre for routine follow-up within the last four months; otherwise, these measurements will be ordered. Participants will complete questionnaires to investigate behavioural and environmental determinants of physical activity. Participants will be fitted with an accelerometer device (activPALTM) and advised to wear it for the next seven days, after which they should return for visit 2. Finally, each participant will receive an activity diary to complete each day.

Visit 2: Participants will return the accelerometer and activity diary. They will also complete the same questionnaires of behavioural and environmental determinants which were administered in visit 1. Finally, participants will complete a utility questionnaire about the accelerometer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

• Blood pressure: Individuals whose blood pressure is under moderate control will be eligible - specifically, treated or untreated resting systolic/diastolic pressure < 160/100 mmHg.

• Lipid control: Individuals with fasting triglyceride concentration < 600 mg are eligible.

Exclusion Criteria:

• HbA1c >9%

• Type 1 diabetes

• Taking insulin

• Pregnancy

• Non-ambulant or severely incapacitated with any medical condition(s) reducing ability to stand or mobilize.

• Currently participating in a study to reduce sedentary behaviour or increase physical activity

• Language. Inability to read and understand Arabic or English language.

• Inability to give informed consent.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Royal College of Surgeons in Ireland - Medical University of Bahrain	Arabian Gulf University, Bahrain, Primary Health Care, Ministry of Health, Bahrain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week (duration of the study)
Secondary	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.	1 week (duration of the study)
Secondary	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.	Day 1/baseline
Secondary	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.	Day 1/baseline
Secondary	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.	Day 1/baseline
Secondary	Exercise Self-Efficacy	Self-efficacy will be investigated using the Exercise Self-Efficacy Scale, which has been validated and is available in English and Arabic. The questionnaire consists of nine items, each of which is scored between zero (not confident) to ten (very confident). The total score is calculated by summing the responses to each question. A higher score indicates higher self-efficacy for exercise. Participants will complete this questionnaire at the start/baseline and end of the study.	Day 1/baseline and end of study (day 7)
Secondary	Motivation to Exercise	Motivation to exercise will be investigated using the Behavioral Regulation in Exercise Questionnaire (BREQ-3). This multidimensional instrument consists of 24 items with a five-point Likert Scale and a separate score for each of the subscales (amotivation, external regulation, introjected regulation, identified regulation, integrated regulation and intrinsic motivation). This instrument is valid, and reliable and is available in English and Arabic (13). Participants will complete this questionnaire at the start/baseline and end of the study.	Day 1/baseline and end of study (day 7)
Secondary	Factors affecting movement behaviour	Factors influencing movement behaviour will be investigated using our modified version of the Capability, opportunity and Motivation (COM-B) questionnaire (14), called the Physical Activity Behaviour Self Evaluation Questionnaire, which consists of 22 items. Participants will complete this questionnaire at the start/baseline and end of the study.	Day 1/baseline and end of study (day 7)
Secondary	Wearability of the ActivPAL device	A utility questionnaire will be used to facilitate feedback from participants about the ActivPAL activity monitor. The questions include a 10-point visual analogue scale from (0) 'very difficult/uncomfortable' through to (10) 'very easy/comfortable' to assess the ease of fitting and comfort of wearing the ActivPAL device. Participants will also be asked to comment on any difficulties wearing the monitors or any strategies they adopted to make it easier to wear them.	Day 7
Secondary	Adverse events	A standard adverse events form will be used to record any significant issues for participants due to the protocol.	Duration of the study and up to two weeks afterwards