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Prevention of diabetes in South Asians with impaired glucose levels: a family based clinical trial using physical activity and dietary modification
ISRCTN ISRCTN25729565
DOI 10.1186/ISRCTN25729565
ClinicalTrials.gov identifier
EudraCT number
Public title Prevention of diabetes in South Asians with impaired glucose levels: a family based clinical trial using physical activity and dietary modification
Scientific title
Acronym PODOSA
Serial number at source G0501310
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.
Lay summary http://www.podosa.org/faq.html
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
Countries of recruitment United Kingdom
Disease/condition/study domain Nutritional, Metabolic and Endocrine Diseases: type 2 Diabetes
Participants - 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)
Participants - 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
Anticipated start date 01/08/2006
Anticipated end date 31/07/2011
Status of trial Completed
Patient information material Patient information can be found in http://www.podosa.org/faq.html
Target number of participants Updated 26/04/10: 170 (At time of registration: 600 recruits with IGT [approx 300 families])
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding MRC National Prevention Research Initiative (UK)
Trial website http://www.podosa.org/index.html
Publications 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
Contact name Prof  Raj  Bhopal
  Address Public Health Sciences
University of Edinburgh
Teviot Place
  City/town Edinburgh
  Zip/Postcode EH8 9AG
  Country United Kingdom
  Tel +44 (0)131 650 3216
  Email Raj.bhopal@ed.ac.uk
Sponsor The Queen’s Medical Research Institute (United Kingdom)
  Address c/o Ms Marise Brown
The Queens’s Medical Research Institute
47 Little France Crescent
  City/town Edinburgh
  Zip/Postcode EH16 4TJ
  Country United Kingdom
  Tel +44 (0)131 650 3231
  Email marise.brown@ed.ac.uk
Date applied 29/01/2007
Last edited 18/03/2014
Date ISRCTN assigned 30/01/2007
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