| CTRI Number |
CTRI/2018/06/014409 [Registered on: 05/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral
Other (Specify) [Diet And Lifestyle] |
| Study Design |
Other |
|
Public Title of Study
|
Role of diet, exercise and bariatric surgery in weight loss management. |
Scientific Title of Study
Modification(s)
|
Impact of nutritional and lifestyle modification in subjects
with BMI 25-29.9kg/m2 vs 30-34.9kg/m2 and to assess the
effect of bariatric surgery in BMI ≥35kg/m2
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IESC/T-342/31.8.2012 |
Other |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Sandeep Aggrawal |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Room No. 5034
Surgical Disciplines
5th Floor Academic Block
AIIMS, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126594905 |
| Fax |
|
| Email |
sandeep_aiims@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Richa Jaiswal |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS |
| Address |
Dietetics Department,
JPN Apex Trauma Center
AIIMS, Raj Nagar
New Delhi
DELHI
110029
India |
| Phone |
9811639745 |
| Fax |
|
| Email |
richajas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Richa Jaiswal |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS |
| Address |
Dietetics Department,
JPN Apex Trauma Center
AIIMS, Raj Nagar
New Delhi
DELHI
110029
India |
| Phone |
9811639745 |
| Fax |
|
| Email |
richajas@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room No. 5034, 5th Floor, Teaching Block,All India Institute of Medical Sciences(AIIMS),Ansari Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Prof Sandeep Aggrawal |
| Address |
5034, 5th Floor Academic Block AIIMS, Ansari Nagar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Mahesh Misra |
Directors Office
AIIMS
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Sandeep Aggrawal |
Surgical Disciplines |
5034,5th Floor, AIIMS, Ansari Nagar
New Delhi
DELHI |
26504905
richajas@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee/ Sub Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E662||Morbid (severe) obesity with alveolar hypoventilation, Obesity and associated comorbidities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1)Nutrition and Lifestyle modification including yoga and other form of exercise |
1) Impact of non surgical weight loss trial in overweight and obese group
|
| Comparator Agent |
2)Nutrition and lifestyle modification for 12 months and bariatric surgery |
2)Impact of Bariatric surgery in comparison to supervised weight loss approach in BMI ≥35 kg/m2 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
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
|
| Outcome |
TimePoints |
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
|
Baseline, 3 month,6month, 1 year |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
06/12/2012 |
| 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="6"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Quality of Life(QOL)and weight loss assessment in patients with BMI≥35kg/m2
OSSICON 2016 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |