Prevention of diabetes in South Asians with impaired glucose levels: a family based clinical trial using physical activity and dietary modification
| ISRCTN | ISRCTN25729565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25729565 |
| Secondary identifying numbers | G0501310 |
- Submission date
- 29/01/2007
- Registration date
- 30/01/2007
- Last edited
- 18/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof Raj Bhopal
Scientific
Scientific
Public Health Sciences
University of Edinburgh
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
| Phone | +44 (0)131 650 3216 |
|---|---|
| Raj.bhopal@ed.ac.uk |
Study information
| Study design | Controlled cluster randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Patient information can be found in http://www.podosa.org/faq.html |
| Scientific title | |
| Study 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(s) | 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 |
| 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 |
| Primary outcome measure | 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 study start date | 01/08/2006 |
| Overall study end date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Updated 26/04/10: 170 (At time of registration: 600 recruits with IGT [approx 300 families]) |
| 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 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
- Scotland
- United Kingdom
Study participating centre
Public Health Sciences
Edinburgh
EH8 9AG
United Kingdom
EH8 9AG
United Kingdom
Sponsor information
The Queens Medical Research Institute (United Kingdom)
University/education
University/education
c/o Ms Marise Brown
The Queenss Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 650 3231 |
|---|---|
| marise.brown@ed.ac.uk | |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Government
MRC National Prevention Research Initiative (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/10/2011 | Yes | No | |
| Results article | results | 22/02/2013 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No | |
| Results article | results | 01/12/2014 | Yes | No |
