Decrease Type II Diabetes in Gestational Diabetes Population
Primary Purpose
Gestational Diabetes, Diabetes Mellitus, Type 2, Breastfeeding
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Video clip
No video clip
Sponsored by
About this trial
This is an interventional health services research trial for Gestational Diabetes
Eligibility Criteria
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
Sites / Locations
- Carmel MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Educational video
Control group
Arm Description
Participants will receive an online video clip, explaining the benefits of breastfeeding.
Participants will not receive the video clip
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rate of OGTT performance
Determination the actual performance of the test
Rate of impaired glucose tolerance (IGT)
Similar to primary outcome
Rate of exclusive breastfeeding
Participants will be asked by a phone cell, about feeding habits, including exclusive, partial and no breastfeeding of the infant
Full Information
NCT ID
NCT05202002
First Posted
January 8, 2022
Last Updated
January 22, 2022
Sponsor
Carmel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05202002
Brief Title
Decrease Type II Diabetes in Gestational Diabetes Population
Official Title
Decreasing the Incidence of Post-partum Type II Diabetes Mellitus in Gestational Diabetes Population- Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Diabetes Mellitus, Type 2, Breastfeeding, Diabetes Mellitus, Type 1, Impaired Glucose Tolerance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational video
Arm Type
Active Comparator
Arm Description
Participants will receive an online video clip, explaining the benefits of breastfeeding.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Participants will not receive the video clip
Intervention Type
Behavioral
Intervention Name(s)
Video clip
Other Intervention Name(s)
Intervention group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No video clip
Other Intervention Name(s)
Control group
Intervention Description
Participants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed.
Primary Outcome Measure Information:
Title
Rate of type II Diabetes Mellitus (DM) diagnosis, as diagnosed by the 75gm oral glucose tolerance test (OGTT)
Description
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
Time Frame
A phone call at 6 weeks postpartum.
Secondary Outcome Measure Information:
Title
Rate of OGTT performance
Description
Determination the actual performance of the test
Time Frame
A phone call at 6 weeks postpartum.
Title
Rate of impaired glucose tolerance (IGT)
Description
Similar to primary outcome
Time Frame
A phone call at 6 weeks postpartum.
Title
Rate of exclusive breastfeeding
Description
Participants will be asked by a phone cell, about feeding habits, including exclusive, partial and no breastfeeding of the infant
Time Frame
A phone call at 6 weeks postpartum.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadav Cohen, MD
Phone
+97248250336
Email
nadavmed88@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadav Cohen, MD
Organizational Affiliation
Carmel MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel MC
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Koos, MD
Phone
+97248250785
Email
danako@clalit.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22011407
Citation
Gunderson EP, Hedderson MM, Chiang V, Crites Y, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Quesenberry CP, Lo JC, Sternfeld B, Ferrara A, Selby JV. Lactation intensity and postpartum maternal glucose tolerance and insulin resistance in women with recent GDM: the SWIFT cohort. Diabetes Care. 2012 Jan;35(1):50-6. doi: 10.2337/dc11-1409. Epub 2011 Oct 19.
Results Reference
result
PubMed Identifier
28244064
Citation
McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD001141. doi: 10.1002/14651858.CD001141.pub5.
Results Reference
result
Learn more about this trial
Decrease Type II Diabetes in Gestational Diabetes Population
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