Based on the available data of conversion of prediabetes to diabetes in one year, and six months, the statistical experts from NIMHANS have arrived at a number of 24,000 prediabetics as the required sample size for this study. We need 24,000 prediabetics from all parts of the country to show any significant reduction in conversion of prediabetes to diabetes within 3 months. In order to get this 24,000, we have to screen 2.4 lakh household population above the age of 20 years round the country.
Randomization and selection of places
We have identified 30 states combining some small states and UTs together. Selection of the number of districts to be covered was based on the population size reported in the 2011 census data (http://censusindia.gov.in/). A list of 30 states along with number of districts in each of this state has been provided in annexure 1. If the size of the state/ UT was small (less than ten districts) then it was clubbed with neighboring state.
Districts in each state were randomly selected based on the ratio of 1:10, i.e., one district would be selected from a state for ten available districts. Thus 60 districts were selected to get the adequate sample size. We need to screen 4000 persons (20-60 years of age) per district throughout India. The total number of persons to be screened is 60 x 4000 = 2.4 lakhs. Hence 2000 persons in urban and rural areas need to be screened in each district.
In each district as the expected prevelance of prediabetes and diabetes is about 10% each, we expect to have 24,000 diabetics and 24,000 prediabetics. Number of subjects for yoga and control groups per district = 200 T2DM, 200 pre-DM.
Selection of Rural population
Door to door survey will be performed to screen 2,40,000 population in 60 districts selected randomly in all states. From each of these districts, rural (villages) and urban (towns & cities) areas have to be randomly selected. We prepared a list of villages of around 150 to 175 households in each districts (population ranging from 500 to 1000) to get about 20 T2DM and 20 pre-DM. To get 24,000 prediabetics and 24,000 diabetics we have randomly selected four villages in each district. Two villages for yoga (neighboring villages) and two villages for control separated by 25 km distance were selected.
Selection in urban
Select any town in the state and cover 4000 population 2000 in one end of the town/ city and 2000 in another end of city/ town in the randomly selected district. One group will be for yoga and one group of 2000 will be control.
Two groups pre-post matched controlled multi-centric design
- Two assessment points: baseline and after 3 months
- Two groups: Yoga and wait-list Control
Inclusion Criteria for diabetes patients:
- Gender: Both male and female
- Age range: 20-60 years
- Diagnosis of T2DM or Pre-DM as per American Diabetic Association guidelines
- Both Gender
- With or without Hypertension
- With or without obesity
- Those on oral hypo-glycemic agents
- Those on insulin
- Fit subjects who can follow the yoga protocol
Exclusion Criteria for diabetes patients:
- Those who are not able to follow the yoga protocol
- H/o of Cardiac illness or any other major complication of diabetes which disables the person
- H/o Major surgery in the past
- H/o Tuberculosis
- H/o Head injury, neurological or psychiatric disorder in the past
Inclusion criteria for pre diabetes
- Adults between 20-60 years
- Both genders
- Hose who score> 50 on IDRS
- Those with HbA1c between 7 and 6.4%
- Those who consent for the study
Exclusion criteria for pre diabetes
- Severe obesity
- Associated cardic and other major illnesses
- Those who cannot do yoga