| CTRI Number |
CTRI/2024/08/072717 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive
Behavioral
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of integrated intensive wellness strategy in Type 2 diabetes with high triglycerides |
|
Scientific Title of Study
|
Evaluation of integrated intensive wellness strategy on biophysiological parameters,life style
practices and quality of life among adults with Type 2 diabetes mellitus with hypertriglyceridemia - A
randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRadhika R |
| Designation |
Ph.D Scholar cum Lecturer |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
No.46, Dept of Community Health Nursing, College of Nursing,
Pondicherry Institute of Medical Sciences, Kalathumettupathai,
Ganapathychettikulam.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9790077116 |
| Fax |
|
| Email |
pravin.radhika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNavaneetha M |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Room no 51, Dept of Community Health Nursing, College of Nursing,
Pondicherry Institute of Medical Sciences, Kalathumettupathai,
Ganapathychettikulam.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9448159718 |
| Fax |
|
| Email |
navamd11176@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNavaneetha M |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Room no 51, Dept of Community Health Nursing, College of Nursing,
Pondicherry Institute of Medical Sciences, Kalathumettupathai,
Ganapathychettikulam.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9448159718 |
| Fax |
|
| Email |
navamd11176@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences, Ganapathichettikulam,Puducherry-14. |
|
|
Primary Sponsor
|
| Name |
DrRadhika R |
| Address |
Pondicherry Institute of Medical Sciences, Ganapathichettikulam,
Puducherry-605014 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Dr Radhika R |
Pondicherry Institute of Medical Sciences |
No.7 Urban health centre ECR Road, Kalapet, Puducherry.
Pondicherry
PONDICHERRY |
9790077116
pravin.radhika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Intensive
Wellness(IIW) Strategy |
IIW Strategy refers to
Comprehensive Lifestyle
Modification therapy such as
Behaviour Change Communication(BCC), Amla Ginger Curry leaves(AGC)juice, Walking program and Alternate Nostril Breathing Exercise.
a).Behaviour Change
Communication(BCC): BCC will
be implemented based on
wellness counselling related to disease process, healthy diet,physical activity, foot care,stress management,tobacco and alcohol cessation on biweekly basis from baseline to 4, 12 & 24 weeks through
mobile phone and home visit.
b).Amla, Ginger and Curry Leaves(AGC) Juice:
Followed by hygienic procedure, Amla -1(60
-70g), 5g ginger and 15 curry
leaves would grind in the mixer jar with little water then filter the ingredients with 200ml water.
Advice the IIW Strategy group
to consume it in an empty
stomach early morning for 3-5
days per week alternatively for Six months. Materials will be supplied alternative days by the Principal investigator and ASHA through home visit and also motivate the family members for proper compliance. Advise the study participants or family members to share the
geotagged image of AGC drinking through whatssapp and
also tick mark in Treatment
compliance tracking diary.
c).Walking program:
Followed by 5 minutes warm up, advised the study group to perform brisk walking for 15-30 minutes, four to five days/week for Six months. All the study participants will be providing training by the PI and ASHA individually during
enrollement, regular home visit and walking videos will be shared through whatssapp
group. Pedometer walking app
will be installed to each study participants for recording the duration.
d).Alternate Nostril Breathing exercise:
It is a type of breathing technique which involves inhalation through one nostril and exhalation through the other nostril for 5-15
minutes once in a day into 3-5
days/week for 6 months in a
calm environment.
All the study participants will be provided training by the PI and ASHA individually during enrollment, regular home visit and breathing
exercise videos will be shared
through whatssapp group.
Advise the study participants or family members to share the
geotagged image of AGC
drinking through whatssapp and
also tick mark in Treatment
compliance tracking diary. |
| Comparator Agent |
Oral Anti-diabetic drugs |
1).Tab Metformin 250mg OD or
BD to 1000mg BD
2).Tab Glimepride 1 or 2mg OD(before breakfast) or Tab Glibenclamide 2.5 to 5mg OD(before breakfast)along with Tab.Metformin for six months as per physician order. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All registered Type 2 DM 30 to 65 years with the FBS greater than 125mg/dl, HbA1C greater than 6.5 and Triglycerides greater than 130mg/dl to lesser than 250 mg/dl will be included in the study
2. A signed and dated written informed consent prior to admission to the study. |
|
| ExclusionCriteria |
| Details |
1.History of any co-morbidities other than hypertension.
2.History of patient on Insulin treatment.
3.Newly registered patient less than one month
4.History of any Amla, ginger and curry leaves allergy.
5.History of Anatomical deformities in Nasal pathway and
Extremities.
6.History of specific Psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Statistically significant reduction of mean of
HbA1c from baseline to weeks 24 and FBS,TGL,SBP, DBP, Weight, BMI, Waist Circumferance from baseline to week 4, 8,12 and week 24 at p value less than 0.05 level in
IIW Strategy than control arm. |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Statistiscally significant improvement in Lifestyle
practices and Quality of life at p value less than 0.05 level in IIW Strategy than Control arm. |
Six months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Research Questions Does integrated intensive wellness strategy have an effect on biophysiological parameters, lifestyle practices and quality of life among Type 2 diabetes mellitus adults with hypertriglyceridemia? 2. Objectives Primary objectives 1. To evaluate the efficacy of Integrated Intensive Wellness Strategy compared with the Control arm on HbA1c from baseline to week 24 among Type 2 diabetes mellitus adults with hypertriglyceridemia at selected urban health and wellness centre in Puducherry. Secondary objectives 2. To evaluate the efficacy of Integrated Intensive Wellness Strategy compared with the Control arm on other Biophysiological parameters, Lifestyle practices and Quality of Life from baseline to week 4, 12 and 24 among Type 2 diabetes mellitus adults with hypertriglyceridemia. 3. To associate the post-interventional Clinical parameters with QOL and lifestyle practices in IIW Strategy arm. 3. Description of study arm A. Intervention arm: Integrated Intensive Wellness Strategy (IIW) IIW Strategy refers to Comprehensive Lifestyle Modification therapy such as BCC, AGC juice, Walking program and Alternate Nostril Breathing Exercise. B. Control arm: Oral antidiabetics 4. Study variables Socio demographic variables Age in years, gender, education, occupation, type of family, annual income of the family, health insurance facility, finance for the treatment ,use of alternative medicines. Clinical variables Duration of treatment, duration of T2DM, Blood pressure, co-morbidities, number and class of anti-diabetics and anti-hypertensives. Outcome variable HbA1C, FBS, Triglycerides, SBP, DBP, Weight, BMI &Waist-Circumferance. Scale on life style practices Eating vegetables, eating fruits, sprinkle salt on food, eating pickle, eating deep fried food/snacks, type of diet, smoke/chew tobacco, drink alcohol, sleep and practice of regular exercises adopted by WHO steps questionnaire and Food frequency questionnaire. WHOQOL-BREF questionnaire for HRQOL domain 5. Data collection and measurements: Formal permission will be obtained from the Directorate of Health and Family welfare(Director Public health and Directorate- ISM),Government of Puducherry for conducting study at UHWC, Muthialpet & Kalapet. For processing biochemical samples formal permission will be obtained from Director-Principal and Laboratory Head, PIMS. Data will be collected by Epi collect 5 Android mobile phone based free application for the following details a. Socio-demographic variables such as age in years, gender, education, occupation, type of family, annual income of the family, health insurance facility, finance for the treatment and use of alternative medicine etc. b. Behavioural measures such as Tobacco use, Alcohol use, Physical activity, Sedentary behavior and Diet pattern. c. Medical history such as CVD, diabetes related medications and any other comorbidity etc., d. Updated family history of disease Following Instruments will be used for the biophysiological measurements in this study Cobas integra 400+ fully automated clinical chemistry analyzer for biochemical parameter Digital electronic blood pressure apparatus for B.P. Mechanical Weighing machine Inch tape for mreasuring height 6. Study variables Socio demographic variables Age in years, gender, education, occupation, type of family, annual income of the family, health insurance facility, finance for the treatment ,use of alternative medicines. Clinical variables Duration of treatment, duration of T2DM, Blood pressure, co-morbidities, number and class of anti-diabetics and anti-hypertensives. Outcome variable HbA1C, FBS, Triglycerides, SBP, DBP, Weight, BMI & Waist-Circumferance. Scale on life style practices Eating vegetables, eating fruits, sprinkle salt on food, eating pickle, eating deep fried food/snacks, type of diet, smoke/chew tobacco, drink alcohol, sleep and practice of regular exercises adopted by WHO steps questionnaire and Food frequency questionnaire. WHOQOL-BREF questionnaire for HRQOL domain 7. Scope of the study This study will helps to promote healthy wellbeing and improve HRQoL at affordable range among diabetics which will create an greater impact to the Individual, Society and Government in view of reducing the burden of disease in healthy way. |