Decrease Type II Diabetes in Gestational Diabetes Population

January 22, 2022 updated by: Nadav Cohen, Carmel Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel MC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Educational video
Participants will receive an online video clip, explaining the benefits of breastfeeding.
Behavioral: Video clip

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.

Other Names:
  • Intervention group
Sham Comparator: Control group
Participants will not receive the video clip
Behavioral: No video clip
Participants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed.
Other Names:
  • Control group

What is the study measuring?

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)
Time Frame: A phone call at 6 weeks postpartum.
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
Time Frame: A phone call at 6 weeks postpartum.
Determination the actual performance of the test
A phone call at 6 weeks postpartum.
Rate of impaired glucose tolerance (IGT)
Time Frame: A phone call at 6 weeks postpartum.
Similar to primary outcome
A phone call at 6 weeks postpartum.
Rate of exclusive breastfeeding
Time Frame: A phone call at 6 weeks postpartum.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Nadav Cohen, MD, Carmel MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

January 8, 2022

First Submitted That Met QC Criteria

January 8, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-20-0041-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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