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A Study on how Freedom From Diabetes Protocol Can Help Manage Obesity and Related Health Issues in India

A Prospective study on the Efficacy of an integrated intensive lifestyle intervention program on management of obesity and associated comorbidities in Indian population - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/071905
Enrollment
90
Registered
2024-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E669- Obesity, unspecified

Interventions

Intervention1: Lifestyle Modification: The duration of the intervention is 1-year. Intervention will consist of Plant-based diet, Physical activity (strength,stamina flexibility exercises including yo

Sponsors

Freedom from diabetes research foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1) Pregnant and lactating women were excluded from the study

Design outcomes

Primary

MeasureTime frame
1) At least a 10% reduction in weight at one year and BMI drop below 23 or at least 3-point dropTimepoint: 1) Reduction in weight and BMI drop will be measured at baseline and at the end of the 12 months

Secondary

MeasureTime frame
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 Timepoint: 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

Countries

India

Contacts

Public ContactDr Nidhi Kadam

Freedom From Diabetes Research Foundation

research@freedomfromdiabetes.org9822792772

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026