Movement Behaviours Among Bahraini Diabetics

NCT06069258 | Recruiting DMC

• 1 other identifier: 284/23-Oct-222
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Physical activity; Behaviour; mHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Activity diary

  1 week (duration of the study)

• Sociodemographic characteristics

  Day 1/baseline

• Anthropometric parameters

  Day 1/baseline

• Clinical parameters

  Day 1/baseline

• Exercise Self-Efficacy

  Day 1/baseline and end of study (day 7)

Study Arms (1)

Bahraini adults with type 2 diabetes

Male and female Bahraini adults aged 20-75 years with controlled type 2 diabetes (i.e. HbA1c \<9 on medication).

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Bahraini adults of all ethnicities with controlled diabetes.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons in Ireland - Medical University of Bahrain: lead
• Ministry of Health, Bahrain: collaborator
• Arabian Gulf University, Bahrain: collaborator
• Royal College of Surgeons, Ireland: collaborator

Study Sites (4)

Isa Town Health Centre

Building 10, Road 43, Manama, Block 743, Bahrain

RECRUITING

Ahmed Ali Kanoo Health Centre

Building 2009, Road 2641, Manama, Block 626, Bahrain

RECRUITING

Halat Bu Maher Health Centre

Building 2858, Road 1653, Muharraq, Block 216, Bahrain

NOT YET RECRUITING

Shaikh Jaber AlSabah Health Centre

Building 6347, Road Nakheel Street, Northern Governorate, Block 518, Bahrain

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ebrahim Rajab, PhD

  Royal College of Surgeons in Ireland - Medical University Bahrain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebrahim Rajab, PhD

CONTACT

16660122; erajab@rcsi.com

Abeer Alsaweer, MBBS

CONTACT

ASaweer@health.gov.bh

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 5, 2023
• Study Start: April 24, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data requests can be submitted 6 months after article publication, and the data will be accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Data obtained through this study may be provided to qualified researchers with academic interest in diabetes and physical activity. To gain access, requestors will need to sign a data access agreement.

Locations

BA (4)