Effectiveness of a multicomponent modular intervention among pregnant women at high risk of developing Gestational Diabetes Mellitus--A hospital based randomized control trial
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Dr Farha Mohammed
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- ·Incidence of GDM in intervention arm and control arm
Overview
Brief Summary
This study is a randomized single-centre open label control trial to test the effectiveness of a multicomponent modular educational intervention at averting the development of GDM among women at risk of developing Gestational Diabetes Mellitus. The sample size is 164, 82 in each arm. All participants will receive standard and routine care. Participants in the intervention arm will receive an educational intervention. Primary outcomes will be incidence of GDM in intervention arm and control arm, mean difference in physical activity scores between intervention arm and control arm, pattern of change in dietary habits pre-intervention and post-intervention and comparison of gestational weight gain between intervention arm and control arm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •All adult pregnant women from Mangalore Taluk who consent to participate in the study, less than or equal to 12 weeks of gestation with singleton pregnancy, and at least one or more risk factors for the development of GDM The risk factors are as follows: BMI at first visit 23kg per m2, Age more than or equal to 25 years, First-degree relative with diabetes, Previous pregnancy with gestational diabetes mellitus, Previous pregnancy with large baby, Previous pregnancy with preeclampsia/eclampsia, History of PCOD or diseases with impaired fasting glucose.
Exclusion Criteria
- •Individuals unwilling to participate in the study, Individuals found to have RBS values more than 200mg/dL at first visit, Prepregnancy diagnosis of Diabetes Mellitus, History of severe hyperemesis in the first trimester, Individuals on medications that interfere with glucose metabolism (eg.
- •Metformin, steroids), History of recurrent first trimester spontaneous abortions, History of stillbirth, History of significant antepartum or postpartum haemorrhage in previous pregnancies, Multiple gestations in current pregnancy, Severe psychiatric disorder or cognitive impairment, Any renal, liver or thyroid dysfunction, Women in whom physical activity is an absolute contraindication during pregnancy as recommended by ACOG (heart disease, restrictive lung disease, incompetent cervix, pregnancies at risk of premature labour, placenta previa, gestational hypertension, severe anemia), Individuals without access to a smartphone.
Outcomes
Primary Outcomes
·Incidence of GDM in intervention arm and control arm
Time Frame: 24 to 28 weeks of gestation
·Mean difference in physical activity scores between intervention arm and control arm
Time Frame: 24 to 28 weeks of gestation
·Pattern of change in dietary habits pre-intervention and post-intervention
Time Frame: 24 to 28 weeks of gestation
·Comparison of gestational weight gain between intervention arm and control arm
Time Frame: 24 to 28 weeks of gestation
Secondary Outcomes
No secondary outcomes reported
Investigators
Farha Mohammed
Kasturba Medical College, Mangalore