Clinical trial NCT06069258: Movement Behaviours Among Bahraini Diabetics
Official title: Movement Behaviours Among Bahraini Type 2 Diabetic Adults: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: Physical activity
Behaviour
mHealth
Lead sponsor: Royal College of Surgeons in Ireland - Medical University of Bahrain
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Bahrain
name: Arabian Gulf University, Bahrain
name: Royal College of Surgeons, Ireland
First posted: 2023-10-05
Enrollment: 340
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Bahraini adults of all ethnicities with controlled diabetes.

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.

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.

Primary outcomes:
measure: Movement behaviour
timeFrame: 1 week (duration of the study)
Secondary outcomes:
measure: Activity diary
timeFrame: 1 week (duration of the study)
measure: Sociodemographic characteristics
timeFrame: Day 1/baseline
measure: Anthropometric parameters
timeFrame: Day 1/baseline
measure: Clinical parameters
timeFrame: Day 1/baseline
measure: Exercise Self-Efficacy
timeFrame: Day 1/baseline and end of study (day 7)
measure: Motivation to Exercise
timeFrame: Day 1/baseline and end of study (day 7)
measure: Factors affecting movement behaviour
timeFrame: Day 1/baseline and end of study (day 7)
measure: Wearability of the ActivPAL device
timeFrame: Day 7
measure: Adverse events
timeFrame: Duration of the study and up to two weeks afterwards
Other outcomes:
Locations:
city: Building 10, Road 43
country: Bahrain
facility: Isa Town Health Centre
state: Capital Governorate
city: Building 2009, Road 2641
country: Bahrain
facility: Ahmed Ali Kanoo Health Centre
state: Capital Governorate
city: Building 2858, Road 1653
country: Bahrain
facility: Halat Bu Maher Health Centre
state: Muharraq Governorate
city: Building 6347, Road Nakheel Street
country: Bahrain
facility: Shaikh Jaber AlSabah Health Centre
state: Northern Governorate
Study officials:
affiliation: Royal College of Surgeons in Ireland - Medical University Bahrain
name: Ebrahim Rajab, PhD
role: PRINCIPAL_INVESTIGATOR
References: