Gestational DiabetesNCT05202002
Decrease Type II Diabetes in Gestational Diabetes Population
A study testing Video clip and No video clip in people with Gestational Diabetes and Diabetes Mellitus, Type 2, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Diabetes Mellitus, Type 2, Breastfeeding
- What is being tested?
- Video clip and No video clip
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2021to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Delivery of a non-viable fetus
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel MC
Haifa, 3436212
Dana Koos, MD, +97248250785, danako@clalit.org.il
About this study
Official title: 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.
- Conditions
- Gestational Diabetes, Diabetes Mellitus, Type 2, Breastfeeding, Diabetes Mellitus, Type 1, Impaired Glucose Tolerance
- Being tested
- Video clip, No video clip
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Breast Feeding, Diabetes Mellitus, Type 1, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video clipBehavioural
Also called Intervention group
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.
No video clipBehavioural
Also called Control group
Participants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed.
| Study group | Role | What they receive |
|---|---|---|
| Educational video | Active comparator | Participants will receive an online video clip, explaining the benefits of breastfeeding. Receives: Behavioral: Video clip |
| Control group | Sham comparator | Participants will not receive the video clip Receives: Behavioral: No video clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: A phone call at 6 weeks postpartum.
Secondary outcomes (3)
Rate of OGTT performance
Determination the actual performance of the test
Measured: A phone call at 6 weeks postpartum.
Rate of impaired glucose tolerance (IGT)
Similar to primary outcome
Measured: 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
Measured: A phone call at 6 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Mar 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadav Cohen, Carmel Medical Center
- Investigators
- Nadav Cohen, MD, Principal investigator, Carmel MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202002
- Sponsor's protocol ID
- CMC-20-0041-CTIL
- Status last verified
- Jan 2022
- First submitted
- 8 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22011407McFadden 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.
PubMed 28244064
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing the Incidence of Post-partum Type II Diabetes Mellitus in Gestational Diabetes Population- Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05202002
- Acronym / sponsor ID
- CMC-20-0041-CTIL
- Conditions
- Gestational Diabetes, Diabetes Mellitus, Type 2, Breastfeeding, Diabetes Mellitus, Type 1, Impaired Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational video | Active comparator | Behavioral: Video clipParticipants will receive an online video clip, explaining the benefits of breastfeeding. |
| Control group | Sham comparator | Behavioral: No video clipParticipants will not receive the video clip |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Delivery of a non-viable fetus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video clipAlso: Intervention groupAfter 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. | Behavioural | Educational video |
| No video clipAlso: Control groupParticipants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed. | Behavioural | Control group |
Primary outcome
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
3 secondary outcomes
Rate of OGTT performance
Time frame: A phone call at 6 weeks postpartum.
Rate of impaired glucose tolerance (IGT)
Time frame: A phone call at 6 weeks postpartum.
Rate of exclusive breastfeeding
Time frame: A phone call at 6 weeks postpartum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Results publication: PubMed 22011407Gunderson 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 publication: PubMed 28244064McFadden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadav Cohen, MD principal investigator
Carmel MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video clip and No video clip in people with Gestational Diabetes and Diabetes Mellitus, Type 2, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadav Cohen, MD (+97248250336, nadavmed88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05202002, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022; AzTrials last refreshed its copy on 26 Oct 2026.