A study to check if overweight and obese women develop diabetes during pregnancy and its relation to their physical activity levels.

Not yet recruiting

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 participantâ€™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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
1. Physical activity levels using IPAQ	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)
(METs.min per week)	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)
2. Quality of Life Questionnaire (WHO QOL BREF)	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)
(each domain will be scored and total scores out of 100)	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)
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 Measures

Name	Time	Method

Locations (1): Obstetrics and Gynaecology Out Patient Department(OPD)
🇮🇳
Udupi, KARNATAKA, India
Obstetrics and Gynaecology Out Patient Department(OPD)
🇮🇳Udupi, KARNATAKA, India
Arya Salgaonkar
Principal investigator
9538578720
aryasalgaonkar@rediffmail.com