Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT06069258
Brief 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.
Detailed 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.
Study:
NCT06069258
Study Brief:
Protocol Section:
NCT06069258