What are the effects of yoga when compared to standard practice on the fasting blood glucose, body mass index, waist circumference and quality of life of diabetic, pre-diabetic and non-diabetic middle-aged people?

Study settings

Hospitals: Thalangama / Athurugiriya / Piliyandala/ Maligawatta/Homagama / Avissawella/Padukka

Healthy life style Centers (HLC) : Thalangama / Athurugiriya / Piliyandala/ Maligawatta/Homagama / Avissawella /Padukka

Community settings (Grama Niladari (GN) divisions Walgama / Athurugiriya south/ Thumbowila west / Maligawatta East /Homagama south/ Puwakpitiya /Padukka

Diabetic and Non-diabetic patients are selected from the registry of the hospital and HLC respectively. Priority is given for the newly registered patients. Therefore selection is started from the last registered one. Then move the upward direction of the registry until 15 patients are enrolled.

The selected patients should fulfill the inclusion & exclusion criteria.

In the community setting: Health screening programme for middle-aged people is conducted at the selected GN areas (approximately 50 participants).

HbA1c test is done for the participants. Then people, whose HbA1c is below 5.7 are selected. Among them, 15 people are selected through random generation number method. (inclusion & exclusion criteria are considered).

Transition from control to intervention is done at the beginning of each quarter of the year.

Education programme on yoga is conducted for every group before practical sessions are started.

Randomization Method

This Stepped Wedge Cluster Randomization trial has four time points, and clusters are randomized in each point where the controls are transited to the intervention. Random Generation Number Software will be used to select the intervention sequence

Interventions

1. Orientation programme will be conducted for the Directors of the hospitals, Divisional Medical Officers, & Medical Officers of Health by the Regional Director of Health Service (co-investigator), Medical Officer (NCD), and Principal Investigator (PI).

2. Training of Public Health staff on Study proceedings and Health Education, based on Health Belief Model (04 hours conducted by PI), Introduction of Yoga (03 hours by PI) and a Practical session of Yoga (Two days by the professionally qualified yoga instructor).

The following category of staff will be trained. Health Education Nursing Officer (NO-HE) of selected hospitals. Public Health Nursing Officers (PHNO) of Healthy Lifestyle centers. Public Health Midwives (PHM) of selected Grama Niladari divisions of MOH area.

1. Each group of participants will have structured Health Education conducted by PI, NO -HE, PHNO and PHM in relevant study settings. (Two hours per week for 4 weeks consecutively).

The baseline measurement of the outcome variables is done by an outsourced biometrician who would take the measurements after intervention.

1. Conducting Yoga sessions by trained staff (60 minutes per day, three days per week for a total of 12 weeks. Two days a week will be at the hospital and HLC setting and one day in their home environment).

At the community settings, participants have to involve the yoga with PHM at the selected community center in the area, in two days per week. In addition to that participants should involve a yoga session in their home environment in once a week.

The PI will participate the session once a week.

This yoga session will be conducted over twelve weeks in each cluster. Monthly review will be done by the RDHS staff, PI, and MOH to ensure the following things, 1. Attendance of the session 2. Obstacles, that participants encountered 3. Any difficulties of health staff As well as, participants are given time to share their experience.

Feedback analysis will be done by the PI. Follow-up visit will be done by the PHM. After 12 weeks outcome variables will be assessed by a Biometrician (out sourced). Quarterly review will be done by the RDHS and research team.

Comparator According to the study design the control cluster becomes intervention state after 12 weeks. Outcome variables of control cluster which is under usual care will be assessed before and after the intervention of previous cluster.

Blinding: Only the outcome assessor is blinded. And will not be involved in any other research proceedings.

• Males or females
• Aged between 40 to 59 years.

• Residing in the selected Medical Officer of Health (MOH) area

• Diabetic group - Registered patient of the diabetic clinic of the selected government hospital in the Colombo district, as well as HbA1c is higher than 6.4%.

• Pre-diabetic group - Identified as pre-diabetic by the Medical Officer of the selected Healthy Lifestyle centers in the Colombo district. As well as HbA1c is between 5.4% - 6.4%.

• Non-diabetic group- HbA1c below 5.7

• Not physically fit enough to engage the yoga, according to the Physical Activity Readiness Questionnaire

• The individuals who engage in any type of exercise programme regularly

• Undergone a recent surgery or is suffering from any uncontrolled comorbidities.

• Patient with diabetes mellitus type 1 or type 2, requiring insulin.

• The person who participates in another clinical study at present or plans to participate within the next twelve months.

• Persons who have any physical impairments that preclude their participation in yoga sessions.

• Currently following a weight-loss diet or planning to start such a diet.

• Mental disorders: diagnosed psychosis that is being treated with psychopharmaceutical drugs, Dementia

• Malignant hypertension (Systolic and Diastolic Blood pressure more than 200 mmHg and 120 mmHg, respectively(Saito & Hasebe, 2021).

• Manifest coronary heart disease, myocardial infarction, pulmonary artery embolism, or apoplexy

• Pregnancy or breastfeeding period.