The estimated sample size based on earlier study [16] on the study variables-Fasting plasma glucose, Glycosylated haemoglobin (HbA1c) and Quality of life at 95% confidence and 80% power varied from 5–40 with an anticipated fall in Fasting plasma glucose (FPG) of 32 mgm/dl and a fall in HbA1c of at least 0.5%. The maximum sample size being 40 the required sample size for the study is 40 for each group totaling 120 for the open label three armed randomized trial.
Study population and Recruitment
The study was conducted in a rural area of Kerala, India at a rural health training centre. The interventions; yoga and peer support were administered for a period of three months. From a population of 19, 000 residing in the self administration-unit (panchayat), 1042 cases of type two diabetes were listed on the basis of a baseline survey in the area (Hospital records, Amrita Community Health Training Centre, Njarackal,Ernakulam district, Kerala,). The women from this list in the 30–65 age groups were contacted and the first 250 women with diabetes were identified and invited to participate in the study. The age 30 was chosen as it was less likely for women less than 30 years to be affected by type two diabetes. The upper age limit was 65 years as they constitute the elderly age group and are more likely to have mobility issues related to osteoarthritis. After clinical screening, willingness and applying the inclusion and exclusion criteria 124 women were enrolled in the study and randomized into three groups (Fig 1).
Inclusion Criteria
Women with type two DM diagnosed within the last 8 years and between 30–65 years of age, HbA1c between 7–10% were included.
Exclusion Criteria
Those already practicing Yoga, Meditation, women with Chronic Alcohol consumption and those with known diabetes complications, pregnant and lactating women, women with diabetes on alternate system of medicine treatment, Body Mass Index (BMI) > 35 kg/m2 and those with serious medical and psychiatric conditions were excluded.
After obtaining written informed consent, the women underwent a baseline assessment by a physician. Those on pharmacologic or non pharmacologic treatment continued with the same. All the study participants were given an education on diet and were advised exercise for at least 10 min per day.
Randomization
The participants were randomized by block randomization of fixed block length of 6. All possible permutations of the three arms A, B, C were listed. A list of independent identically distributed random numbers were generated and chosen. Each number in this list was then replaced by the block. The random allocation sequence was generated by a person not connected with the study at the main hospital and handed over to the research assistant at the health centre in numbered opaque sealed envelopes. The allocation ratio was approximately 1:1:1. Enrollment was carried out by Principal investigator
Ethics Committee Approval was obtained from the Institutional Ethics committee of Amrita Institute of Medical sciences dated Aug 8 2011. The trial was registered with the CTRI/2011/12/002227.
Intervention
Yoga Intervention
Instructor driven yoga sessions were conducted for 60 min on two days a week. Yoga sessions were conducted by the yoga instructor who had a diploma in yoga and Naturopathy and was assisted by two trained persons with masters in medico-social work (MSW). On the other days the women were instructed to practice at home and maintain a daily log. The 60 min sessions consisted of 25 min-Surya namaskara-12 steps, 5–7 min-Deep relaxation-Muscle relaxation technique, 15 min Asana or yoga postures. The postures consisted of Pavanamuktasana in the supine position, Bhujangasana and Shalabhasana in the prone position, Ardhamatsyaendrasana in the sitting position as recommended by yoga experts for diabetes [17]. This was followed by 15 min of pranayama. A record of the food eaten, drugs consumed and exercise particulars were also maintained for two days a week considered to be representative of the entire week. This was reviewed every month. On the basis of this record the dietician determined adherence to diet based on the approximate calorie consumption in relation to the type of work done (sedentary/moderate/heavy work).
If any of the study participants were found to have hypoglycaemia (Random plasma glucose (RPG) < 70 g/dl) in the monthly review with or without symptoms the oral drugs was reduced by 20–50%.
Peer support intervention
Three Peer mentors were identified from the community and trained. The criteria for eligibility was; having had type two Diabetes for at least one year with a RPG ≤250 mg/dl in the last reading, judged by the investigation team to be generally adherent to treatment and behaviour change regime, capacity and commitment to undergo the training required, an understanding of patients confidentiality, undertaking to liaise with the concerned doctor if unanticipated problems arose during the course of their peer support activity. The peer mentors provided support to the study participants in a ratio of 1:14. Peer Mentors underwent a two day training programme consisting of a physician who explained aetiology of diabetes, changes taking place in the body due to Diabetes, complications due to poor glycaemic control and an outline on the drugs used and its mechanism of action and the synergies with physical activity. The nutrition specialist explained all the nutritional and dietary aspects of diabetes; psychologist trained the peer mentors on communication skills, empathy, confidentiality. A training manual was prepared for the peer mentors based on the peers for progress handbook and handed over to the mentors for future reference.
Peer support meetings: Each peer mentor would visit 13–14 women with diabetes. A face to face meeting with the woman with diabetes in a week for about 45–60 min on assistance in applying disease management or prevention plans in daily life, providing emotional and social support and pro active flexible ongoing support. This was followed up by a telephone call in the same week. A monthly review of the activities was also undertaken by the principal investigator. During the first visit, the peer mentor collected the treatment details including drugs, diet and physical activity. In the follow up visits the peer mentor advised and monitored the woman regarding diet, exercise, timely consumption of drugs, emotional stress, symptoms, foot care etc. In the third month during the last visit the peer mentor conducted a final assessment regarding the entire process, its acceptability, difficulties and usefulness to the woman with diabetes. The woman with diabetes in the peer support group was also given a diary to record the visit, advice of the peer mentor and the changes brought about.
The control group was given the usual standard of care including continuing oral hypoglycaemic drugs, advise on diabetic diet and exercise for at least 10 min a day to a level of 150 min/week. All the patients were reviewed monthly and necessary care given. A pretested, semi structured questionnaire was used to collect socio demographic and other information.
Outcome measures
The primary outcomes studied were fasting plasma glucose, HbA1c, quality of life and pharmacological adherence. The effect on quality of life will be discussed elsewhere. Adherence to drugs was measured by Morisky Medication adherence scale (MMAS–8) [18] in the local language, Malayalam and it was scored according to guidelines with a maximum score of 8. Fasting plasma glucose was measured by Hexokinase method, HbA1c by the High performance liquid chromatography method and cholesterol oxidase-peroxidase method for cholesterol. The secondary outcomes studied were BMI and waist hip ratio (WHR), blood pressure and total cholesterol (the last two were added later as funds became available). Anthropometric measurements like weight, height, waist and hip circumference were recorded by standard methods [19] at the beginning before randomisation and at the end of three months at a post treatment visit. Those who took the measurements were not aware of the group to which the patient belonged.
To understand the process, feedback was collected from both the intervention groups. Yoga group’s attendance was monitored and more than 80% of attendance in instructor classes was considered as regular. Dietary adherence was operationalized by recording the food eaten on the day previous to the yoga class. The total calorie consumed was calculated by the dietician according to the nature of work and was deemed to be adherent or non adherent.
Statistical methods: Mean and Standard Deviation (SD) were computed for all the measurable study variables for each intervention group. To test significance of the differences in mean values of the study variables, from basal to the follow-up period; within each group, paired t test was applied and among the three groups, one-way Analysis of Variance was applied. In case of statistical significance, multiple comparison test was applied to identify significantly different pairs of groups.