| CTRI Number |
CTRI/2023/12/060861 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Screening
Behavioral
Nutraceutical
Other (Specify) [Lifestyle Intervention- Diet, physical activity, stress management] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Freedom From Diabetes Protocol on improvement in Anxiety and Depression in patients with Type 2
diabetes in India |
|
Scientific Title of Study
|
Mental Health Outcomes in Patients with Type 2 Diabetes Enrolled for the Diabetes Remission Study in India (DiRemI) |
| Trial Acronym |
DiRemI |
|
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 |
Manager, Research |
| 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 |
Manager, Research |
| 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
MAHARASHTRA
411004
India |
| Phone |
9822792772 |
| Fax |
|
| Email |
research@freedomfromdiabetes.org |
|
|
Source of Monetary or Material Support
|
| Freedom from diabetes research foundation (Host Institution) |
|
|
Primary Sponsor
|
| Name |
Freedom from diabetes research foundation (Host Institution) |
| Address |
Parth, First Floor, Ghodke Chowk, Prabhat Road, Pune |
| 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 |
Parth, First Floor, 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: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifestyle modification |
The duration of the intervention is 6 months, with a 6-month follow-up post intervention. The intervention will
consist of a Plant-based diet,
Physical activity (strength,
stamina, flexibility exercises,
including yoga), stress
management (Counselling
sessions and meditation), in addition to medical management |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Confirmed diagnosis of Type 2 Diabetes
2) Agree to examinations as per the study protocol,
undergo the lifestyle intervention program & post-program evaluation
3)Participants who are well-oriented in time, and
space & as a person
4)Provide written informed consent |
|
| 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) Gestational Diabetes mellitus (diabetes diagnosed in the second or
third trimester of pregnancy that was not clearly overt diabetes prior
to gestation).
3)Specific types of diabetes due to other causes, eg., monogenic diabetes syndromes, diseases of exocrine pancreas, drug or chemical induced diabetes
4) Pregnant or lactating women
5) Patients who have required hospitalization for any diabetes-related complications in the last 6 months or for depression or are on antipsychotic drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Mental Health outcomesAnxiety & Depression (in terms of reduction in
scores below 10 for both anxiety & depression) |
At baseline and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) At least 10% reduction in weight and HbA1c
2) Improvement in co-morbidities and complications (nephropathy)
3) Improvement in biochemical parameters- serum lipids, fasting and post prandial blood glucose levels |
AT baseline and at 6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/01/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 prevalence of depression, anxiety, and diabetes distress in patients with T2DM enrolled in a diabetes remission program and to determine the effect of the program in improving their mental health outcomes (anxiety, depression, and
diabetes distress). Specific Objectives are: 1) To assess the prevalence of anxiety, depression, and diabetes distress in patients with T2D enrolled at the Freedom from Diabetes clinic for diabetes management through a lifestyle modification program. 2) To deliver an online intervention to improve mental health in those who have
depression and anxiety. 3) To evaluate the effect of this intervention in reducing the prevalence of anxiety, depression, and diabetes distress scores among patients with T2D. 4) To study the effect of mental health on the outcome of the intervention in terms of remission and overall improvement in diabetes management. The
intervention comprises lifestyle modification with a plant-based diet, exercise, psychological support, and medical management. Trained psychologists will provide a targeted intervention focusing on those with anxiety and depression through group therapy as well as individual counseling. The intervention will be 12 months
(6-month intervention + 6-month follow-up). Data (socio-demographic data, administration of PHQ-9 scale, GAD-7, and T2-DDAS) will be collected at two-point times, at the baseline and end-line at the end of 6 months after the delivery of the intervention. Compliance data will be collected from patients based on their levels of
both anxiety and depression. Adherence data will be collected from patients. |