| CTRI Number |
CTRI/2024/09/073292 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral
Nutraceutical
Other (Specify) [Lifestyle modification ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Can a one year lifestyle change program help people with type 2 diabetes in India spend less on managing their condition |
|
Scientific Title of Study
|
Impact of an Intensive Lifestyle Intervention Program on Out of Pocket Expenditure for the Management of Type 2 Diabetes in India- A One Year Prospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramod Tripathi |
| Designation |
Director |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.1,Parth, Ghodke Chowk Prabhat Road,
Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
drpramod@freedomfromdiabetes.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Head of the Department (HoD) |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.1,Parth, Ghodke Chowk Prabhat Road,
Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Kadam |
| Designation |
Head of the Department (HoD) |
| Affiliation |
Freedom From Diabetes Research Foundation |
| Address |
Research department, Freedom from Diabetes Research Foundation, First floor, Room no.1,Parth, Ghodke Chowk Prabhat Road,
Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
|
Source of Monetary or Material Support
|
| Freedom from Diabetes Research Foundation
First floor, Room no.1,
Parth, Ghodke Chowk, Prabhat Road,
Pune,
MAHARASHTRA,
411004
India
(Host Institution)
|
|
|
Primary Sponsor
|
| Name |
Freedom From Diabetes Research Foundation |
| Address |
First floor, Room no.1,
Parth, Ghodke Chowk, Prabhat Road,
Pune,
MAHARASHTRA,
411004
India
|
| Type of Sponsor |
Research institution |
|
|
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 Nidhi Kadam |
Freedom from Diabetes Clinic |
Research department, Freedom from Diabetes Research
Foundation, First floor, Room no.7,Parth, Ghodke Chowk Prabhat
Road, Pune
Pune
MAHARASHTRA |
9822792772
research@freedomfromdiabetes.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Freedom from Diabetes Research Foundation- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifestyle modification |
The duration of the intervention is 1-year. Intervention will consist of 4 components-
1) Plant-based diet
2) Physical activity (strength,
stamina flexibility exercises including yoga)
3) stress management (Counselling sessions and meditation
4) routine medical management |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Written informed consent.
2. Men and women aged 30-70 years.
3. Confirmed diagnosis of type 2 Diabetes- All patients on treatment with oral hypoglycemic agents and/or Insulin or any Ayurvedic
anti-diabetic medications or HbA1c ≥ 48 mmol/mol (6.5%) with or without medication.
4. Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation.
5. Well-oriented in time, space & as a person. |
|
| ExclusionCriteria |
| Details |
1. Type 1 diabetes (due to autoimmune b-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood).
2. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation).
3. Gestational diabetes mellitus (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation).
4. Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assess the effect of the ILI program in reducing the OOP expenditure for T2D management
2. Estimate the average OOP expenditure for T2D patients. |
Out of expenditure will be measured at 2 time points- baseline and at the end of 12 months i.e. 52 weeks of the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Identify factors associated with higher OOP expenditure.
2. Evaluate the relationship between OOP expenditure, medication adherence & glycemic control. |
Out of expenditure will be measured at 2 time points- baseline & at the end of 12 months i.e. 52 weeks of the intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="1"
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
|
The proposed study is a single-arm pre-post design intervention trial that aims to assess the OOP expenditure for T2D treatment in patients with T2DM enrolled in a diabetes remission program and to evaluate the effectiveness of a one-year intensive lifestyle intervention (ILI) program on OOP expenditure for T2D patients. Specific Objectives are: 1) To assess the impact of a one-year online Intensive Lifestyle Intervention (ILI) on OOP expenditure of T2D patients in India. 2) To estimate the OOP expenditure for managing type 2 diabetes. 3) To identify factors associated with OOP expenditure 4) To assess the impact of OOP expenditure on medication adherence and glycemic control. The intervention comprises lifestyle modification with a plant-based diet, exercise, psychological support, and medical management. The intervention will be 12 months (6-month intervention + 6-month follow-up). Data (socio-demographic data, disease severity, treatment regimen, healthcare utilization patterns, administration of expenditure questionnaire) will be collected at two-point times, at the baseline and end-line at the end of 12 months after the delivery of the intervention. Compliance data will be collected from patients. Adherence data will be collected from patients. |