Efficacy of Risk Mitigation Strategies on Physiological, Bio-chemical and Behavioral Risk factors of Cardiovascular Diseases among Adults.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Level of risk cardiovascular diseases will be reduced after 24 months of intervention
Study Overview
Brief Summary
This study is a non randomized control trail multicentric, comparing the efficacy of Risk Mitigation Strategies such as Nurse led education on prevention of risk factors of cardiovascular diseases, alternative nasal breathing, aerobic exercise, sunlight exposure and vitamin D3 supplementation 60000IU per week for 6-8 weeks. The study intervention will be divided into experiemental arm 1 with risk mitigation strategies and arm 2 with supplementaion of vitamin D3. The primary outcome of the study will be measured useing biochemical parameters such as lipid profile, FBS and vitamin D3 level and the secondary outcome will be measure using self structured behavious modification scale and bio physiological parameters such as BMI, Blood pressure and waist circumferences after 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
Eligibility Criteria
- Ages
- 21.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Adults between the ages of 21-60 years.
- •2 Adults who have mild, moderate level of CVD risk 3 Adult who have deficient and insufficient vitamin D3 level 4 Adults who are willing to participate.
Exclusion Criteria
- •1 Adults who are pregnant, skin disorders ( Such as skin burns, Psoriasis etc) 2 Adults who are in steroids and thiazide diuretics.
- •3 Adults who are already with Vitamin D3 supplements.
Outcomes
Primary Outcomes
Level of risk cardiovascular diseases will be reduced after 24 months of intervention
Time Frame: 24 months
Secondary Outcomes
- Improvement in behaviour towards prevention of risk on cardiovascular diseases(6 months)
- Pysiological risk factors towards cardiovascular diseases will be reduced after the intervention(6 months)
Investigators
Sasikala Palayan
Sri Ramachandra Faculty of Nursing, SRIHER