| CTRI Number |
CTRI/2011/12/002227 [Registered on: 14/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Peer Support] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A trial to understand the effect of Yoga therapy and Peer support on women with Type II Diabetes Mellitus |
|
Scientific Title of Study
|
A randomised Control Trial on the effectiveness of Yoga therapy and Peer support on women with Type II Diabetes Mellitus |
| Trial Acronym |
YOPS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAswathyS |
| Designation |
Professor |
| Affiliation |
Amrita School Of Medicine,Amrita Institute of Medical Sciences |
| Address |
Dept. Of Community Medicine
Amrita School Of Medicine,
Amrita Institute of Medical Sciences,Amrita Vishwa Vidyapeetham,PonnekaraP.o.Ernakulam.Kerala
50/140 A,Parnasree,
Ponnevazhi Road,Edapally
Ernakulam,Kerala-682024.
Ernakulam
KERALA
682041
India |
| Phone |
9447294260 |
| Fax |
04842802020 |
| Email |
aswathys@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAG Unnikrishnan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Dept. Of Endocrinology
Amrita Institute of Medical Sciences,Amrita Vishwa Vidyapeetham,PonnekaraP.o.
Ernakulam,Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9846005343 |
| Fax |
04842802020 |
| Email |
unnikrishnanag@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrAswathyS |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita School Of Medicine,
Amrita Institute of Medical Sciences,Amrita Vishwa Vidyapeetham,PonnekaraP.o.Ernakulam.Kerala
50/140 A,Parnasree,
Ponnevazhi Road,Edapally
Ernakulam,Kerala-682024.
Ernakulam
KERALA
682041
India |
| Phone |
9447294260 |
| Fax |
04842802020 |
| Email |
aswathys@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Peers for Progress,N.Carolina and Amrita Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of medical sciences with monetary support from Peers for progressNCarolina |
| Address |
Amrita Institute of Medical sciences,Ponnekara P.O Ernakulam.Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAswathyS |
1.Amrita institute Of medical Sciences,kochi,Kerala |
Lecture hall,Amrita Community Health Training Centre,Njarakkal,Dept. Of Community Medicine,AIMS.
Ernakulam
KERALA |
9447294260
04842802020
aswathys@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences, Cochin |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type II Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
This group will receive the general standard of care. They will continue their antidiabetes medication and will be followed up for a period of three months. |
| Intervention |
Peer Support |
Peer Group: Peer mentors will be identified by health workers and three-four of them will be trained .The criteria for eligibility will be
 Having had type 2 Diabetes for at least one yr with a RBS 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
 Understanding of the importance of patients confidentiality
 Undertaking to liase with the concerned Dr if unanticipated problems arose during the course of their peer support activity
• Peer Mentors Training: They will undergo training by the research team in two morning sessions. This will focus on basics of type 2 Diabetes and issues relating to working with groups and confidentiality
• Peer support meetings: One Face to Face meeting with the patient 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.Each peer mentor will visit 10-12 women with Type II DM.
This will be followed up by a telephone call.
Peer review:A review of the activities will be undertaken once a month by the investigators
The period of intervention is three months.
|
| Intervention |
Yoga |
• Yoga therapy sessions for 60 min on two days a week
• On the other days they will be asked to practice at home and to maintain a diary
• 60 min session-
25 min-Surya namaskara-12 steps
5-7 min-Deep relaxation-Muscle relaxation technique
15 min Asanas
Supine position-Pavanamuktasana
Prone position-Bhujangasana,Shalabhasana
Sitting position-Ardhamatsyaendrasana
15 min-2 types of pranayama-Nadi shudhi& Bhramari
The duration of therapy is three months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Adult females between 30-65 yrs with a diagnosis of type 2 diabetes mellitus within the last 8 years. The diabetes must be uncontrolled with Hba1c equal to or more than 7% with normal cognitive function.
|
|
| ExclusionCriteria |
| Details |
Those already practicing Yoga, Meditation and those with known Diabetes Complications, pregnant &lactating women, any serious medical condition, on Homeo and Ayurvedic treatment and BMI>35. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fasting Blood Sugar &Hba1c,Quality of Life measured by WHOQOLbref and Pharmacological adherence measured by Morisky scale. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body Mass Index,waist Hip ratio |
3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
11/04/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Prevalence of Type 2 Diabetes has increased rapidly in the Asian Population.In India 30 million people are Diabetic which will rise to about 60 million by 2017 (Kutty &Raju, IJMR,2010). As India experiences a rapid health transition, the mismatch between health care needs and resources is widened by an expanded list of health conditions that vie for attention from policy makers and public health action. The complexities are further compounded when policy has to prioritise on the basis of diseases burden, cost effectiveness and equity .Reddy ,2003).
The increasing rate of Diabetes in Asia is associated with a strong gene-environmental interaction which is propelled by lifestyle changes caused by modernisation. The overall prevalence rate of diabetes in urban and rural areas combined was estimated as 62.47 per thousand (Bela etal,2004). There is evidence that the population of Kerala is also having a high prevalence of major risk factors for Chronic Non Communicable Disease (Thankappan etal,2010).Estimates also show that Kerala may become the Diabetic Capital of India. The age standardized prevalence for Diabetes in Kerala works out to 14.9% in men and 13.2% in women (diabetoz.com-HAP study).
Diabetes mellitus has been described as the most complex and demanding of any chronic disease to manage. This is because it requires : modification of dietary practices, weight management, exercise, monitoring of body fluids (blood,urine),footcare, use of drugs, learning new technical skills such as blood glucose monitoring. Health care systems need to be redesigned to deliver chronic care that is founded on existing primary care facilities, but supported by good referral systems. Inaction will affect millions of lives-often the lives of those who have the least(Antonio et al,2011).To deal with the increasing morbidity and mortality it is important to develop and evaluate low cost interventions that build on available resources and can empower patients (Michele,2007).It is necessary to look at alternatives which are not resource intensive and which is nearer to the community that people live in. Yoga and Peer support are two such alternatives. Yoga holds promise as a therapeutic intervention and health promotion measure, though studies are not conclusive. Similarly Peer support is also considered a promising, potentially low cost, flexible means to supplement formal health care support. Peer support has been defined as the provision of support from an individual with experiential knowledge based on a sharing of similar life experiences or prevention plans in daily life.
The future offers challenges and opportunities to deal with the burden to the individual suffering from a chronic disease like Diabetes.
The null hypothesis is that Yoga and Peer support do not have any effect on women with Type II DM.The alternative hypothesis is that Yoga and Peer support are effective adjuncts to treatment. |