Movement Behaviours Among Bahraini Diabetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 20 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bahrain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Movement Behaviours Among Bahraini Type 2 Diabetic Adults: a Cross-sectional Study
Overview
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.
Primary outcome measures
- Movement behaviour [Time frame: 1 week (duration of the study)]
Secondary outcome measures (9)
- Activity diary [Time frame: 1 week (duration of the study)]
- Sociodemographic characteristics [Time frame: Day 1/baseline]
- Anthropometric parameters [Time frame: Day 1/baseline]
- Clinical parameters [Time frame: Day 1/baseline]
- Exercise Self-Efficacy [Time frame: Day 1/baseline and end of study (day 7)]
- Motivation to Exercise [Time frame: Day 1/baseline and end of study (day 7)]
- Factors affecting movement behaviour [Time frame: Day 1/baseline and end of study (day 7)]
- Wearability of the ActivPAL device [Time frame: Day 7]
- Adverse events [Time frame: Duration of the study and up to two weeks afterwards]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Bahrain · 4 centers
- Isa Town Health Centre — Building 10, Road 43
- Ahmed Ali Kanoo Health Centre — Building 2009, Road 2641
- Halat Bu Maher Health Centre — Building 2858, Road 1653
- Shaikh Jaber AlSabah Health Centre — Building 6347, Road Nakheel Street
Identifiers
NCT: NCT06069258 · 284/23-Oct-222