Decrease Type II Diabetes in Gestational Diabetes Population

Study Overview
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Brief Summary
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The goal of the study is to examine the impact of an educational video on the rate of breastfeeding in mothers who had gestational diabetes mellitus, and the rate of type-II diabetes mellitus diagnosed postpartum.

Official Title
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Decreasing the Incidence of Post-partum Type II Diabetes Mellitus in Gestational Diabetes Population- Prospective Randomized Controlled Trial

Conditions
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Gestational Diabetes, Diabetes Mellitus, Type 2, Breastfeeding, Diabetes Mellitus, Type 1, Impaired Glucose Tolerance

Intervention / Treatment
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* Behavioral: Video clip
* Behavioral: No video clip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant individuals aged over 18 years old Diagnosed with Gestational Diabetes Mellitus (GDM) by 100gm oral glucose tolerance test (OGTT) done between week 24-28 of gestation, or by other criteria (50gm glucose challenge test (GCT) >200 mg/dl22 or having one abnormal value in OGTT ) Having pregestational diabetes (DM-I or DM-II) Can read and understand Hebrew Exclusion Criteria: Delivery of a non-viable fetus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Educational video<br>Participants will receive an online video clip, explaining the benefits of breastfeeding. | Behavioral: Video clip<br>* After obtaining written informed consent, participants received a sealed envelope containing a preprinted paper referral to an online website, with a unique identifier. After entering the online website, participants will be asked to enter the unique identifier they have received into a text box. Only those whose identifiers were predetermined to be associated with the intervention group will receive the intervention. The intervention is twenty minutes long educational video clip, in which a brief discussion was presented, by an obstetrician, pediatrician, dietitian, and a breastfeeding consultant, each presenting the benefits of breastfeeding for mother and newborn.<br>* Other names: Intervention group;|
| Sham Comparator: Control group<br>Participants will not receive the video clip | Behavioral: No video clip<br>* Participants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of type II Diabetes Mellitus (DM) diagnosis, as diagnosed by the 75gm oral glucose tolerance test (OGTT) | Participants are requested to perform 75gm oral glucose tolerance test (OGTT) postpartum, as a screening test for type I diabetes mellitus. We will record the results and compare between groups | A phone call at 6 weeks postpartum. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of OGTT performance | Determination the actual performance of the test | A phone call at 6 weeks postpartum. | 
| Rate of impaired glucose tolerance (IGT) | Similar to primary outcome | A phone call at 6 weeks postpartum. | 
| Rate of exclusive breastfeeding | Participants will be asked by a phone cell, about feeding habits, including exclusive, partial and no breastfeeding of the infant | A phone call at 6 weeks postpartum. |