Movement Behaviours Among Bahraini Type 2 Diabetic Adults: a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 4
- 主要终点
- Movement behaviour
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Movement behaviour
时间窗: 1 week (duration of the study)
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.
次要结局
- Factors affecting movement behaviour(Day 1/baseline and end of study (day 7))
- Activity diary(1 week (duration of the study))
- Sociodemographic characteristics(Day 1/baseline)
- Anthropometric parameters(Day 1/baseline)
- Adverse events(Duration of the study and up to two weeks afterwards)
- Clinical parameters(Day 1/baseline)
- Exercise Self-Efficacy(Day 1/baseline and end of study (day 7))
- Motivation to Exercise(Day 1/baseline and end of study (day 7))
- Wearability of the ActivPAL device(Day 7)