Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420817
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Brief Title:
Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians
Sponsor:
Jubilee Mission Medical College and Research Institute
Organization:
Jubilee Mission Medical College and Research Institute
Study Overview
Official Title:
Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIP
Brief Summary:
Lifestyle medicine is a medical specialty that uses evidence-based therapeutic interventions to prevent treat and reverse chronic conditions Studies have shown that a 50 mgdl reduction in LDL reduces the risk of developing stroke by 20 and a 10 mm Hg reduction in systolic BP reduces the risk of developing MACE by 22 and stroke by 41 The CLIP Cholesterol Lowering Lifestyle Intervention Project is an innovative initiative proposed to evaluate the combined effect of an Indian version of Portfolio diet-based nutrition strategy intermittent fasting exercise sleep and stress reduction techniques on lowering blood lipid levels in health professionals and their family The study aims to evaluate the effect of CLIP on changes in blood pressure weight HbA1C levels blood CRP levels and other blood parameters
Detailed Description:
Lifestyle medicine is a medical specialty that uses evidence based therapeutic lifestyle interventions as a primary modality to prevent treat and often reverse chronic conditions using whole food plant-based diet physical activity restorative sleep stress reduction avoiding risky substances and positive social connections with or without medications
Epidemiological and interventional studies have shown clearly that a 50 mgdl reduction in LDL reduces the risk of developing stroke by 20 and a 10 mm Hg reduction in systolic BP reduces the risk of developing MACE by 22 and the risk of developing stroke by 41Enas EA et al Indian Heart Journal 2011 cadiresearchorg Studies by the nutrition expert David JA Jenkins and colleagues from Toronto University have shown that grouping plant based whole foods which have their own cholesterol lowering ability when eaten alone will have a larger effect when they are eaten together or combined into a portfolio as part of a regular diet httpsjamanetworkcomjournalsjamafullarticle 196970 The portfolio diet plan has been subsequently shown to reduce cholesterol similar to powerful cholesterol-lowering drugs without any side effects in various other studies as well However no study has so far looked at the effects of this diet on Indian population Also no reported study in the world so far has looked at the effects of a combination of lifestyle medicine interventions including the Indianized version of portfolio diet on the reduction of lipid levels in health care workers CLIP Cholesterol lowering Lifestyle Intervention Project is an innovative lifestyle medicine intervention project that we propose to carry out under the academic guidance of the Dept of Lifestyle Medicine CMC Vellore
Research Question Will a customised lifestyle medicine strategy over a period of 4 weeks lower blood lipid levels significantly in adults between 18 and 70 years
Null Hypothesis A customised lifestyle medicine strategy over a period of 4 weeks will not significantly lower blood lipid levels in adults between 18 and 70 years Type of study A Quasi Experimental Study
Time duration
Preparation 4 weeks Intervention 4 weeks Result compilation and analysis 4 months Total 6 months
AIM To evaluate the combined effect of an Indian version of Portfolio diet-based nutrition strategy Intermittent fasting Exercise Sleep and Stress Reduction Techniques on lowering blood lipid levels in health professionals and their family
Secondary objectives To evaluate the effect of the CLIP interventions on the changes in
Blood Pressure
Weight
HbA1C levels
Blood CRP levels
Other blood Parameters including Lipo A
The study would be done in 2 phases In the first phase the pretest questionnaire would be administered through google forms and health education on whole food plant-based diet physical activity restorative sleep stress reduction avoiding risky substances would be given
In the second phase Intervention would be carried out and monitoring would be done online daily weekly by the investigative team
Population Willing members of health professionals and their family Inclusion Criteria All willing health professionals and their family aged between 18 and 70 years
Exclusion Criteria
Those who have been started on any medication for chronic illnesses unless sufficient period 3 months is over for stabilization of parameters on those medications
People on insulin steroids and warfarin
Those who alter their medications during the intervention
Those who are unfit to exercise
Methods
Enrolment and Training
All the participants who meet the criteria for the study will be enrolled from an already existing WhatsApp group of Modern Medicine doctors and their family interested in lifestyle interventions
The study protocol will be familiarised online through social media platforms on the basic concepts of lifestyle medicine in general and the interventions adopted in particular before the commencement of the intervention
Consenting members will be enrolled in the study and will undergo the following interventions
I Baseline Screening The following parameters will be evaluated by the participants during the preparation stage before the commencement of the intervention
Anthropometry Clinical Height Weight Waist Circumference Waist to Hip Ratio BP Biochemistry Lipid Profile Apolipoprotein B Lipoprotein A HbA1C Blood sugar Fasting and PP CRP LFT RFT Uric Acid TSH
II Lifestyle Interventions The participants will be supervised to
follow the prescribed diet plan
do intermittent fasting for 12 hours daily and
join for an hour of group online exercise program 3 days a week
Monitor the sleep duration as per PSQI Pittsburgh sleep quality index scores
Exercise Duration 180 minutes per week including cardio strength training and flexibility
Compliance Adherence to all interventions planned will be monitored through a weekly questionnaire software like habit tracker and online Zoom meetings
III Final Evaluation Final Anthropometry Clinical and Biochemical Parameters achieved will be obtained at the end of 4 weeks Pre and post biochemical evaluation will be done by the participants in the same lab
Expected outcome of the study It is expected that diet and other lifestyle interventions included in the study will lower total cholesterol and LDL levels primary outcomes of the participants in proportion to their degree of compliance to interventions
1 Proportion of participants achieving reduction in BMI Waist to Hip Ratio
2 Proportion of hypertensive participants achieving reduction in BP
3 Proportion of DM participants achieving reduction in HbA1C
4 Proportion of participants achieving reduction in TC LDL levels
5 Proportion of participants achieving reduction in all the other biochemical parameters studied
Epidemiological and interventional studies have shown clearly that a 50 mgdl reduction in LDL reduces the risk of developing stroke by 20 and a 10 mm Hg reduction in systolic BP reduces the risk of developing MACE by 22 and the risk of developing stroke by 41Enas EA et al Indian Heart Journal 2011 cadiresearchorg Studies by the nutrition expert David JA Jenkins and colleagues from Toronto University have shown that grouping plant based whole foods which have their own cholesterol lowering ability when eaten alone will have a larger effect when they are eaten together or combined into a portfolio as part of a regular diet httpsjamanetworkcomjournalsjamafullarticle 196970 The portfolio diet plan has been subsequently shown to reduce cholesterol similar to powerful cholesterol-lowering drugs without any side effects in various other studies as well However no study has so far looked at the effects of this diet on Indian population Also no reported study in the world so far has looked at the effects of a combination of lifestyle medicine interventions including the Indianized version of portfolio diet on the reduction of lipid levels in health care workers CLIP Cholesterol lowering Lifestyle Intervention Project is an innovative lifestyle medicine intervention project that we propose to carry out under the academic guidance of the Dept of Lifestyle Medicine CMC Vellore
Research Question Will a customised lifestyle medicine strategy over a period of 4 weeks lower blood lipid levels significantly in adults between 18 and 70 years
Null Hypothesis A customised lifestyle medicine strategy over a period of 4 weeks will not significantly lower blood lipid levels in adults between 18 and 70 years Type of study A Quasi Experimental Study
Time duration
Preparation 4 weeks Intervention 4 weeks Result compilation and analysis 4 months Total 6 months
AIM To evaluate the combined effect of an Indian version of Portfolio diet-based nutrition strategy Intermittent fasting Exercise Sleep and Stress Reduction Techniques on lowering blood lipid levels in health professionals and their family
Secondary objectives To evaluate the effect of the CLIP interventions on the changes in
Blood Pressure
Weight
HbA1C levels
Blood CRP levels
Other blood Parameters including Lipo A
The study would be done in 2 phases In the first phase the pretest questionnaire would be administered through google forms and health education on whole food plant-based diet physical activity restorative sleep stress reduction avoiding risky substances would be given
In the second phase Intervention would be carried out and monitoring would be done online daily weekly by the investigative team
Population Willing members of health professionals and their family Inclusion Criteria All willing health professionals and their family aged between 18 and 70 years
Exclusion Criteria
Those who have been started on any medication for chronic illnesses unless sufficient period 3 months is over for stabilization of parameters on those medications
People on insulin steroids and warfarin
Those who alter their medications during the intervention
Those who are unfit to exercise
Methods
Enrolment and Training
All the participants who meet the criteria for the study will be enrolled from an already existing WhatsApp group of Modern Medicine doctors and their family interested in lifestyle interventions
The study protocol will be familiarised online through social media platforms on the basic concepts of lifestyle medicine in general and the interventions adopted in particular before the commencement of the intervention
Consenting members will be enrolled in the study and will undergo the following interventions
I Baseline Screening The following parameters will be evaluated by the participants during the preparation stage before the commencement of the intervention
Anthropometry Clinical Height Weight Waist Circumference Waist to Hip Ratio BP Biochemistry Lipid Profile Apolipoprotein B Lipoprotein A HbA1C Blood sugar Fasting and PP CRP LFT RFT Uric Acid TSH
II Lifestyle Interventions The participants will be supervised to
follow the prescribed diet plan
do intermittent fasting for 12 hours daily and
join for an hour of group online exercise program 3 days a week
Monitor the sleep duration as per PSQI Pittsburgh sleep quality index scores
Exercise Duration 180 minutes per week including cardio strength training and flexibility
Compliance Adherence to all interventions planned will be monitored through a weekly questionnaire software like habit tracker and online Zoom meetings
III Final Evaluation Final Anthropometry Clinical and Biochemical Parameters achieved will be obtained at the end of 4 weeks Pre and post biochemical evaluation will be done by the participants in the same lab
Expected outcome of the study It is expected that diet and other lifestyle interventions included in the study will lower total cholesterol and LDL levels primary outcomes of the participants in proportion to their degree of compliance to interventions
1 Proportion of participants achieving reduction in BMI Waist to Hip Ratio
2 Proportion of hypertensive participants achieving reduction in BP
3 Proportion of DM participants achieving reduction in HbA1C
4 Proportion of participants achieving reduction in TC LDL levels
5 Proportion of participants achieving reduction in all the other biochemical parameters studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None