Contact information

Type

Scientific

Primary contact

Prof Raj Bhopal

ORCID ID

Contact details

Public Health Sciences
University of Edinburgh
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
+44 (0)131 650 3216
Raj.bhopal@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0501310

Study information

Scientific title

Acronym

PODOSA

Study hypothesis

Current information as of 26/04/10:
Does a family-based three-year programme promoting weight loss and increased physical activity in South Asians with impaired glucose tolerance and/or impaired fasting glucose, result in a clinically meaningful weight loss in the intervention group compared to the control group?

Initial information at time of registration:
To evaluate whether a 3-year family based programme combining weight loss and physical activity can reduce the incidence of type 2 diabetes in South Asians with impaired glucose tolerance.

Please note that as of 26/04/10, this record has been updated. All updates may be found in the relevant field with the above update date. Please also note that the anticipated end date of this trial has been extended from 31/07/11 to 31/01/13.

Ethics approval

Added 27/04/10:
Scotland A Research Ethics Committee approved on the 15th of March 2007 (ref: 07/MRE10/2). Substantial amendment to protocol to change primary outcome and sample size was approved on the 29th of June 2009

Study design

Controlled cluster randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Patient information can be found in http://www.podosa.org/faq.html

Condition

Nutritional, Metabolic and Endocrine Diseases: type 2 Diabetes

Intervention

Intervention group will receive 15 contacts with trained dieticians over 3 years with the goal of reducing weight and increasing physical activity.
Control group will receive 4 contacts over 3 years to provide health information.

Current information as of 26/04/10:
Intervention and control group - 85 recruits in each group plus family volunteers.

Initial information at time of registration:
Intervention and control group - 300 recruits in each group plus family volunteers.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Current information as of 26/04/10:
Weight change at 3 years.

Initial information at time of registration:
To evaluate whether a 3-year family based programme combining weight loss and physical activity can reduce the incidence of type 2 diabetes in South Asians with impaired glucose tolerance.

Secondary outcome measures

Added 26/04/10:
1. Changes in fasting and 2-hour glucose
2. Progression to type 2 diabetes
3. Body Mass Index (BMI)
4. Waist circumference and hip circumference
5. Cost effectiveness

Overall trial start date

01/08/2006

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Self-assigned ethnic group using Census 2001 categories as Indian or Pakistani
2. Normal place of residence is in Greater Glasgow & Clyde or Lothian Health board areas
3. Given informed consent
4. Impaired glucose tolerance (IGT) on oral glucose tolerance test (OGTT) at least once
5. An age of 35 or more
6. A waist size of > 90 cm (men) or > 80 cm (women)
7. No confirmed medical history of diabetes (other than gestational diabetes)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Updated 26/04/10: 170 (At time of registration: 600 recruits with IGT [approx 300 families])

Participant exclusion criteria

1. The main cook for the potential participant with IGT is unwilling to give consent to cooperate
2. A diagnosis of diabetes made on the OGTT during the screening phase of the study
3. Other disease where adherence to the intervention is contraindicated or improbable e.g. terminal illness or psychological or physical illnesses; alcohol dependency; planned or actual pregnancy; use of prescribed drugs that affect the primary outcome
4. An expectation, reported by participants or the GP, that the person will be emigrating or dying before the conclusion of the trial
5. Failure to make a commitment to stay in the study until, at least, the three year follow-up examination

Recruitment start date

01/08/2006

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Public Health Sciences
Edinburgh
EH8 9AG
United Kingdom

Sponsor information

Organisation

The Queen’s Medical Research Institute (United Kingdom)

Sponsor details

c/o Ms Marise Brown
The Queens’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 650 3231
marise.brown@ed.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

MRC National Prevention Research Initiative (UK)

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21978409
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23435795
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23574693
4. 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24622752

Publication citations

  1. Results

    Douglas A, Bhopal RS, Bhopal R, Forbes JF, Gill JM, Lawton J, McKnight J, Murray G, Sattar N, Sharma A, Tuomilehto J, Wallia S, Wild SH, Sheikh A, Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians)., Trials, 2011, 12, 220, doi: 10.1186/1745-6215-12-220.

  2. Results

    Douglas A, Bhopal RS, Bhopal R, Forbes JF, Gill JM, McKnight J, Murray G, Sattar N, Sharma A, Wallia S, Wild S, Sheikh A, Design and baseline characteristics of the PODOSA (Prevention of Diabetes & Obesity in South Asians) trial: a cluster, randomised lifestyle intervention in Indian and Pakistani adults with impaired glycaemia at high risk of developing type 2 diabetes., BMJ Open, 2013, 3, 2, doi: 10.1136/bmjopen-2012-002226.

  3. Results

    Wallia S, Bhopal RS, Douglas A, Bhopal R, Sharma A, Hutchison A, Murray G, Gill J, Sattar N, Lawton J, Tuomilehto J, McKnight J, Forbes J, Lean M, Sheikh A, Culturally adapting the prevention of diabetes and obesity in South Asians (PODOSA) trial., Health Promot Int, 2013, doi: 10.1093/heapro/dat015.

  4. Results

    Bhopal RS, Douglas A, Wallia S, Forbes JF, Lean ME, Gill JM, McKnight JA, Sattar N, Sheikh A, Wild SH, Tuomilehto J, Sharma A, Bhopal R, Smith JB, Butcher I, Murray GD, Effect of a lifestyle intervention on weight change in south Asian individuals in the UK at high risk of type 2 diabetes: a family-cluster randomised controlled trial., Lancet Diabetes Endocrinol, 2014, 2, 3, 218-227, doi: 10.1016/S2213-8587(13)70204-3.

Editorial Notes