A trial to understand the effect of Yoga therapy and Peer support on women with Type II Diabetes Mellitus

Completed

• Conditions: Type II Diabetes mellitus

• Registration Number: CTRI/2011/12/002227
• Lead Sponsor: Amrita Institute of medical sciences with monetary support from Peers for progressNCarolina

Brief Summary

Prevalence of Type 2 Diabetes has increased rapidly in the Asian Population.In xml:namespace prefix = st1 /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).xml:namespace prefix = o /

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-04
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Adult females between 30-65 yrs with a diagnosis of type 2 diabetes mellitus within the last 8 years.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting Blood Sugar &Hba1c,Quality of Life measured by WHOQOLbref and Pharmacological adherence measured by Morisky scale.	3 months

Secondary Outcome Measures

Name	Time	Method
Body Mass Index,waist Hip ratio	3 months

Trial Locations

Locations (1)

1.Amrita institute Of medical Sciences,kochi,Kerala; 🇮🇳 Ernakulam, KERALA, India

1.Amrita institute Of medical Sciences,kochi,Kerala

🇮🇳Ernakulam, KERALA, India

DrAswathyS

Principal investigator

9447294260

aswathys@aims.amrita.edu