Health benefits of a COMmunity-based WALKing programme in Bahraini adults with type 2 diabetes

ISRCTN ISRCTN49941929
DOI https://doi.org/10.1186/ISRCTN49941929
Secondary identifying numbers N/A
Submission date
14/06/2011
Registration date
21/06/2011
Last edited
22/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Usha Sachdeva
Scientific

Arabian Gulf University
Manama
22979
Bahrain

Phone +973 (0)1 723 9776
Email ushasach@agu.edu.bh

Study information

Study designPilot randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEfficacy 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
Study acronymCOMWALK2
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedType 2 diabetes
InterventionFollowing 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 typeBehavioural
Primary outcome measureChange in haemoglobin A1c between baseline and the end of the 12-week programme
Secondary outcome measures1. 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 study start date10/01/2011
Completion date01/02/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants45
Key inclusion criteria1. 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%.
Key exclusion criteria1. 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
Date of first enrolment10/01/2011
Date of final enrolment01/02/2012

Locations

Countries of recruitment

  • Bahrain

Study participating centre

Arabian Gulf University
Manama
22979
Bahrain

Sponsor information

Arabian Gulf University (Bahrain)
University/education

College of Medicine & Medical Sciences
Manama
22979
Bahrain

Phone Tel: +973 (0)1 723 9888
Email meddean@agu.edu.bh
Website http://www.agu.edu.bh
Ahlia University (Bahrain)
University/education

PO Box 10878
Manama
-
Bahrain

Arabian Gulf University
Not defined

Funders

Funder type

University/education

Arabian Gulf University (Bahrain) (research grant No. 72)

No information available

Ahlia University (Bahrain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan