Plain English Summary
Background and study aims
Type 2 diabetes is a metabolic disease characterised by high blood sugar which over time may lead to complications which impair quality of life and reduce life expectancy. Despite its small size, the proportion of the population in Bahrain which is affected by type 2 diabetes is one of the highest in the world. The risk of developing this disease is increased if an individual is obese and/or physically inactive, and it is anticipated that cases of type 2 diabetes in Bahrain will continue to rise due to the high proportion of the population affected by these two conditions. High levels of physical activity such as walking are known to improve control of blood sugar and to reduce the risk of complications from types 2 diabetes. However, many diabetic patients are not active enough. Furthermore, there is still debate about the best approach to deliver or supervise walking programmes for these patients. The aim of this study is to test the procedures that will be used in a larger study to find out about the health benefits of a community-based walking programme for Bahraini adults with type 2 diabetes.
Who can participate?
Bahraini adults aged 24-60 with type 2 diabetes.
What does the study involve?
Participants will be randomly allocated to one of three treatments: standard diabetes treatment alone; standard diabetes treatment with physical activity education to promote walking; or standard treatment with physical activity education to promote walking and a step counter to record daily walking activity. Patients will have their blood glucose, physical activity level, fitness and body composition assessed at the start, middle (6 weeks) and end (12 weeks) of the study.
What are the possible benefits and risks of participating?
The investigators believe that the risks to the participants are minimal.
Where is the study run from?
Arabian Gulf University (Bahrain).
When is the study starting and how long is it expected to run for?
From January 2011 to February 2012.
Who is funding the study?
Arabian Gulf University and Ahlia University, Manama, Kingdom of Bahrain.
Who is the main contact?
Professor Usha Sachdeva
ushasach@agu.edu.bh
Trial website
Contact information
Type
Scientific
Primary contact
Prof Usha Sachdeva
ORCID ID
Contact details
Arabian Gulf University
Manama
22979
Bahrain
+973 (0)1 723 9776
ushasach@agu.edu.bh
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of a COMmunity-based WALKing programme with or without a pedometer on markers of glucose control, cardio-respiratory fitness and lung inflammation in Bahraini adults with type 2 diabetes: a pilot randomised controlled trial
Acronym
COMWALK2
Study hypothesis
The aim of this pilot study is to test the robustness of the protocol and of the study methodologies prior to conducting the study on a larger group of patients. The main objectives of the pilot study are:
1. To test the integrity of the study protocol including inclusion/exclusion criteria, the randomisation process, storage and testing of equipment and materials, and training of staff in administration and assessment procedures.
2. To obtain initial data for the primary outcome measure haemoglobin A1c, in order to perform a sample size calculation for the main study.
3. To determine compliance with and acceptability of the exercise intervention by patients.
4. To test that the self-assessment questionnaires, information documents and consent forms are comprehensible and appropriate.
Ethics approval
1. Research Technical Support Team, Ministry of Health, Kingdom of Bahrain, 04/10/2010, ref: FA/SA/971/2010
2. Research & Ethics Committee, Arabian Gulf University, Kingdom of Bahrain, 16/02/2010
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
Following baseline measurements, patients will be randomly assigned to one of three groups (n=15 each):
1. Standard diabetes treatment alone (i.e. control)
2. Standard treatment and two one-hour sessions of group-based physical activity education, each delivered at six week intervals, to promote walking
3. Standard treatment, a pedometer and two one-hour sessions of group-based physical activity education, each delivered at six week intervals, to promote steps-per-day goals.
Contact details:
Principal Investigator:
U. Sachdeva MD, PhD
Department of Physiology
Arabian Gulf University
P. O. Box 22979, Manama
Kingdom of Bahrain
Co-Investigators: E. Rajab PhD MCSP2, M. M. F. Subhan PhD1, P. Trinidad MD, MRS, PT2
Department of Physiology
Arabian Gulf University
P. O. Box 22979, Manama
Kingdom of Bahrain
The numbers after the qualifications of each author refer to their home institution.
1= Arabian Gulf University
2= Ahlia University
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Change in haemoglobin A1c between baseline and the end of the 12-week programme
Secondary outcome measures
1. Pedometry (steps/day)
2. Physical activity level (International Physical Activity Questionnaire)
3. Fraction of nitric oxide in exhaled air (FeNO) to evalaute cardiorespiratory fitness
4. Body Mass Index
5. Percent body fat
6. Blood glucose
Assessed at baseline, 6 and 12 weeks
Overall trial start date
10/01/2011
Overall trial end date
01/02/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Bahraini adults (aged 24-60 years) with type 2 diabetes (as defined by the American Diabetic Association, 1997) for more than 6 months
2. A baseline haemoglobin A1c of 6.6% to 9.9%.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant exclusion criteria
1. Current insulin therapy
2. Participation in exercise two or more times per week for more than or equal to 20 minutes/session during the previous 6 months
3. Changes during the previous 2 months in oral hypoglycaemic, antihypertensive or lipid-lowering agents and body weight (more than or equal to 5%)
4. Serum creatinine level of 200 µmol/L or greater
5. Proteinuria greater than 1g/d
6. Blood pressure greater than 160/95 mm Hg
7. Restrictions in physical activity because of disease
8. Presence of other medical conditions that make participation inadvisable
Recruitment start date
10/01/2011
Recruitment end date
01/02/2012
Locations
Countries of recruitment
Bahrain
Trial participating centre
Arabian Gulf University
Manama
22979
Bahrain
Sponsor information
Organisation
Arabian Gulf University (Bahrain)
Sponsor details
College of Medicine & Medical Sciences
Manama
22979
Bahrain
Tel: +973 (0)1 723 9888
meddean@agu.edu.bh
Sponsor type
University/education
Website
Organisation
Ahlia University (Bahrain)
Sponsor details
PO Box 10878
Manama
-
Bahrain
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Arabian Gulf University (Bahrain) (research grant No. 72)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ahlia University (Bahrain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary