Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/06/2011
Date assigned
21/06/2011
Last edited
22/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.agu.edu.bh

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

Publication citations

Additional files

Editorial Notes