Decrease Type II Diabetes in Gestational Diabetes Population

NCT ID: NCT05202002

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-05-30

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Educational video

Participants will receive an online video clip, explaining the benefits of breastfeeding.

Group Type ACTIVE_COMPARATOR

Video clip

Intervention Type BEHAVIORAL

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.

Control group

Participants will not receive the video clip

Group Type SHAM_COMPARATOR

No video clip

Intervention Type BEHAVIORAL

Participants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Intervention group Control group

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Nadav Cohen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadav Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel MC

Locations

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Carmel MC

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Nadav Cohen, MD

Role: CONTACT

+97248250336

Facility Contacts

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Dana Koos, MD

Role: primary

+97248250785

References

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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.

Reference Type RESULT
PMID: 22011407 (View on PubMed)

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.

Reference Type RESULT
PMID: 28244064 (View on PubMed)

Other Identifiers

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CMC-20-0041-CTIL

Identifier Type: -

Identifier Source: org_study_id

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