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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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