| CTRI Number |
CTRI/2024/08/071905 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| 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
|
A Study on how Freedom From Diabetes Protocol Can Help Manage Obesity and Related Health Issues in India |
|
Scientific Title of Study
|
A Prospective study on the Efficacy of an integrated intensive lifestyle intervention program on management of obesity and associated comorbidities in Indian population |
| 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 |
9881912050 |
| 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 (Host Institution) First floor, Room No. 1, Parth, Ghodke Chowk Prabhat Road,Pune
MAHARASHTRA
411004
India |
|
|
Primary Sponsor
|
| Name |
Freedom from diabetes research foundation |
| Address |
First Floor, Room No. 1, Parth, Ghodke Chowk, Prabhat Road, Pune,
State: Maharashtra
Pincode: 411004
Country: 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: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifestyle Modification |
The duration of the intervention is 1-year. Intervention will consist of Plant-based diet, Physical activity (strength,stamina flexibility exercises including yoga), stress management (Counselling sessions and meditation), routine medical management |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with Obesity (BMI 25 to 35 kg/m2, WHO Asia Pacific Guidelines)
2)Participants who are well-oriented in time, and
space & as a person
3)Provide written informed consent
4)Physical and mental ability to take part in the study
5)No severe health issues and have not been hospitalized in the past six months
6)Agree to examinations as per the study protocol,
undergo the lifestyle intervention program & post-program evaluation |
|
| ExclusionCriteria |
| Details |
1) Pregnant and lactating women were excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) At least a 10% reduction in weight at one year and BMI drop below 23 or at least 3-point drop |
1) Reduction in weight and BMI drop will be measured at baseline and at the end of the 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Improvement in body composition (BC) parameters (fat percent, visceral fat percent, sub-cutaneous fat percent, skeletal muscle mass)
2)Improvement in Mental Health outcomes for Anxiety and Depression (in terms of reduction in scores below 10 for both anxiety and depression)
3)Improvement in sleep quality (in terms of reduction in scores below 5)
4)Improvement in physical activity levels (in terms of increased metabolic equivalent of task (MET) values above 600 MET-minutes/week)
5)Improvement in co-morbidities and complications (Prediabetes,T2D, Dyslipidemia,Hypertension)
6)Improvement in biochemical parameters- serum lipids, HbA1c, fasting and post-prandial blood glucose levels. serum creatinine, eGFR, SGPT, SGOT, urine microalbuminuria, and C-reactive protein
|
1)Improvement in body composition will be measured at baseline and at the end of the 12 months.
2)Improvement in Mental health and Sleep quality- At baseline and at 6 months
3)Physical activity assessment at baseline and 12 months
4)For biochemical parameters- At baseline, and at the end of 12 months
5)Co-morbidities and complications- At baseline, and at 12 months
|
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
02/09/2024 |
| 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="9" 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 prospective, quasi-experimental, single-arm pre-post design that aims to assess the effect of an integrated intensive lifestyle intervention (ILI) in the management of obesity and associated comorbidities. The specific objectives of this study are 1) To assess the impact of an online intensive lifestyle intervention on weight loss, body mass index (BMI), and body composition (BC) parameters. 2) To assess the prevalence of comorbidities including prediabetes, T2D, dyslipidemia, hypertension, anxiety, depression, and stress. 3)To assess the effect of the intervention on improvements in comorbidities. 4)To assess the baseline characteristics of obese participants who attended an ILI-based management program. 5) To investigate the associations between clinical, anthropometric, biochemical, mental health, sleep quality, and physical activity outcomes in individuals with obesity. The targeted intervention will include dietary, exercise, psychological, and medical management. The mode of delivery of the intervention will be through online group sessions and individual counseling. The duration of the intervention will be one year. The data on sociodemographics will be collected at the time of enrollment. Data on anthropometric, body composition (measured by Karda scan and DXA), biochemical parameters (e.g., Serum Lipids, Fasting, and post-prandial plasma glucose, creatinine/eGFR. LFT, RFT), and GPAQ (physical activity), will be collected at baseline and the end of the intervention (12 months). Meanwhile, data for the PHQ-9, GAD-7 (Depression and Anxiety), and PSQI (sleep quality index) scales will be collected at baseline and at the end of 6 months. To check the compliance adherence data will be collected from the patients. |