Role of diet, exercise and bariatric surgery in weight loss management.
- Conditions
- Morbid (severe) obesity with alveolar hypoventilation, Obesity and associated comorbidities,
- Registration Number
- CTRI/2018/06/014409
- Lead Sponsor
- Prof Sandeep Aggrawal
- Brief Summary
Overweight and obesity is growing rapidly in India which indicates that safe, effective and less expensive tools are required to address the problem. Nutritional counseling and lifestyle modification is effective in lower BMI sub group but findings indicate it is not equally effective to address the weight related problem of the obese group (≥30 kg/m2). Relevant research in this area, in India is minimal and the data available is mostly inconsistent. Due to absence of scientific data of supervised non surgical intervention in different BMI sub group it is difficult to claim the effectiveness of this treatment module in different BMI sub group .
Therefore it is proposed to carry out a study to see the impact of supervised non surgical intervention in different BMI sub group (Group I: ≥25-29.9 & Group- II: ≥ 30 kg/m2) and assess the difference between supervised non surgical and surgical intervention in morbidly obese patients (BMI ≥35 kg/m2 with co-morbidities or BMI ≥40 kg/m2). The findings of the study will help in formulation of strategies to control the problem among the target groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria for first cohort (Group I): a) Adult aged between 18-65 yrs b) BMI 25-29.9 kg/m2 Inclusion Criteria for second cohort (GroupII): a)Adult aged between 18-65 yrs b)Normal adult BMI >29.9 kg/m2 to 34.9 kg/m2 Inclusion criteria for nonsurgical intervention in morbidly obese group: a)BMI ≥35 kg/m2 b)Adult aged between 18-65 yrs Inclusion criteria for surgical intervention in morbidly obese group: a)Adult aged between 18-65 yrs b)BMI ≥35 kg/m2 with co-morbidities or BMI ≥40 kg/m2 c)All non surgical measures have been tried but have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 month d)Patient with no psychological or clinical contraindications to anesthesia or surgery e)Patient who have comprehension and commitment to long term follow up.
Exclusion Criteria for first cohort (Group I): 1)Age below 18 yrs and above 65yrs 2)BMI >29.9kg/m2 3)Pregnant or lactating mothers 4)Acute or severe chronic illness or severe end organ damage 5)Patient is on some drug/s which can lead to hyperglycemia 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake 7)Patient who refuse consent for the study Exclusion Criteria for second cohort (Group II) 1)Age below 18 yrs and above 65yrs 2)BMI ≥35kg/m2 3)Pregnant or lactating mothers 4)Acute or severe chronic illness or severe end organ damage 5)Patient is on some drug/s which can lead hyperglycemia 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake 7)Patient who refuse consent for the study Exclusion criteria for nonsurgical intervention in morbidly obese group: 1)BMI <35 kg/m2 2)Age below 18 yrs and above 65yrs 3)Pregnant or lactating mothers 4)Acute or severe chronic illness or severe end organ damage 5)Patient is on some drug/s which can lead hyperglycemia 6)Secondary cause of obesity: any endocrinological dysfunction, drug intake 7)Patient who refuse consent for the study Exclusion criteria for surgical intervention for morbidly obese group: 1)Age below 18 yrs and above 65yrs 2)BMI ≥35 kg/m2 without co-morbidities or BMI <40 kg/m2 3)Pregnant or lactating mothers 4)Young female patients who have plan to extend family in next 2 years 5)Acute or severe chronic illness or severe end organ damage 6)Patient is on some drug/s which can lead hyperglycemia 7)Secondary cause of obesity: any endocrinological dysfunction, drug intake 8)Patient who are high risk for surgery 9)Patient who refuse consent for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method c. Physical activity level a.Change in weight,Excess weight, waist circumference and waist to hip ratio | b. Quality of life | c. Physical activity level | d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval | e. blood chemistry examination | f. Blood pressure: | g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated | h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval a.Change in weight,Excess weight, waist circumference and waist to hip ratio | b. Quality of life | c. Physical activity level | d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval | e. blood chemistry examination | f. Blood pressure: | g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated | h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test a.Change in weight,Excess weight, waist circumference and waist to hip ratio a.Change in weight,Excess weight, waist circumference and waist to hip ratio | b. Quality of life | c. Physical activity level | d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval | e. blood chemistry examination | f. Blood pressure: | g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated | h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test b. Quality of life a.Change in weight,Excess weight, waist circumference and waist to hip ratio | b. Quality of life | c. Physical activity level | d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval | e. blood chemistry examination | f. Blood pressure: | g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated | h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test e. blood chemistry examination a.Change in weight,Excess weight, waist circumference and waist to hip ratio | b. Quality of life | c. Physical activity level | d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval | e. blood chemistry examination | f. Blood pressure: | g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated | h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test f. Blood pressure: a.Change in weight,Excess weight, waist circumference and waist to hip ratio | b. Quality of life | c. Physical activity level | d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval | e. blood chemistry examination | f. Blood pressure: | g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated | h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated a.Change in weight,Excess weight, waist circumference and waist to hip ratio | b. Quality of life | c. Physical activity level | d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval | e. blood chemistry examination | f. Blood pressure: | g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated | h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test a.Change in weight,Excess weight, waist circumference and waist to hip ratio | b. Quality of life | c. Physical activity level | d. Chang in behavior by the assessment of eating pattern, alcohol consumption and smoking rate, at 3 month,6 month and 1 year interval | e. blood chemistry examination | f. Blood pressure: | g. Change in FBS, FIL, Thyroid function, LFT, HbA1C, if indicated | h.Evaluation of serum iron, folate, and vitamin B12 levelin all morbidly obese patient as their routine test
- Secondary Outcome Measures
Name Time Method 1)To assess the impact of intervention on Quality of life and psycho-social functioning in all the groups of patients 2) To assess the impact of intervention on parameters of metabolic syndrome in all the groups of patients
Trial Locations
- Locations (1)
Surgical Disciplines
🇮🇳Delhi, DELHI, India
Surgical Disciplines🇮🇳Delhi, DELHI, IndiaProf Sandeep AggrawalPrincipal investigatorrichajas@yahoo.com