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CTRI Number  CTRI/2018/05/013912 [Registered on: 16/05/2018] Trial Registered Prospectively
Last Modified On: 06/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to check if overweight and obese women develop diabetes during pregnancy and its relation to their physical activity levels. 
Scientific Title of Study   Association between physical activity levels and risk for gestational diabetes mellitus among overweight and obese women. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arya Salgaonkar 
Designation  Post Graduate student 
Affiliation  School of Allied Health Sciences,Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy School of Allied Health Sciences Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9538578720  
Fax    
Email  aryasalgaonkar@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhamini Krishna Rao 
Designation  Professor 
Affiliation  School of Allied Health Sciences, Manipal Academy of Higher Education 
Address  Department of Physiotherapy School of Allied Health Sciences Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  bhamini.kr@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Arya Salgaonkar 
Designation  post graduate student 
Affiliation  School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy School of Allied Health Sciences Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9538578720  
Fax    
Email  aryasalgaonkar@rediffmail.com  
 
Source of Monetary or Material Support  
Arya Salgaonkar(Self sponsored study) Department of Physiotherapy School of Allied Health Sciences, Manipal Academy Of Higher Education Manipal 
 
Primary Sponsor  
Name  Arya Salgaonkar 
Address  Department of Physiotherapy School of Allied Health Sciences Manipal MAHE 
Type of Sponsor  Other [self sponsored study] 
 
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 
Arya Salgaonkar  Obstetrics and Gynaecology Out Patient Department(OPD)  Kasturba Hospital Manipal Academy of Higher Education, Manipal 576104 Karnataka, Udupi district
Udupi
KARNATAKA 		 9538578720

aryasalgaonkar@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Overweight and obese pregnant women,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Primigravidae with BMI >23kg/m2 2. Age group 18 to 40 years  
 
ExclusionCriteria 
Details  1. Women with random blood sugar (RBS) >130mg/dl in the initial gestational period (1st
visit)
2. High risk pregnancies (IUI, IVF, placental anomalies, advised bed rest, cervix
encirclage, multiple gestation)
3. Women with history of PCOS and on Metformin
4. Any other systemic illness/autoimmune disease
5. Cardiovascular diseases preventing physical activity
6. Musculoskeletal deformities of lower limb which will interfere normal physical activity 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Physical activity levels using IPAQ
(METs.min per week)
2. Quality of Life Questionnaire (WHO QOL BREF)
(each domain will be scored and total scores out of 100)
3. Oral Glucose Tolerance Test values (OGTT) (glucose values mg/dl: fasting, 1st hour, 2nd hour )  		 3 time points
(1st visit between:8th-13th weeks of gestation)
(2nd visit between:18th to 20th week of gestation)
(3rd visit between:24th -28th week of gestation) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/06/2018 
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="0"
Months="6"
Days="18" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
 The proposed study protocol was approved from Institutional Research Committee (IRC dated 15-12-2017). Ethical clearance from Institutional Ethics Committee (IEC) was obtained (IEC No: 96/2018). The study will be initiated by screening for potential participants according to the inclusion criteria and will be conducted in settings of Kasturba hospital assuring the privacy of the participant. Enrolled participants will be informed about the procedure of the study and an informed consent will be obtained. Baseline parameters like height and weight will be taken to calculate the BMI to classify them as overweight and obese. The potential participants will be administered with the IPAQ-SF and WHO quality of life BREF questionnaires during their first visit to hospital (8th-13th week of gestation) and their Random Blood Sugar (RBS) values will be noted from medical file. Women with RBS value >130mg/dl and preexisting (overt) diabetes will be excluded. Included participants will be followed and identified during their second and third visit (between 18th to 20th and 24th to 28th week of gestation) and both the questionnaires (IPAQ & WHOQOL) will be readministered. During their third visit participant’s oral glucose tolerance test (OGTT) values will be noted from medical file. Values will be used to categorize the women into GDM and Non-GDM. Data analysis will be done the basis of information collected. 
 
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