GDM and maternal-fetal adverse outcomes rates after providing lifestyle recommendations based on a motivational video early in pregnancy. The St Carlos video_MED_DIET Study
| ISRCTN | ISRCTN20122349 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20122349 |
| Secondary identifying numbers | CI 23/616-E |
- Submission date
- 31/10/2023
- Registration date
- 02/11/2023
- Last edited
- 19/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Gestational diabetes mellitus (GDM) is a big problem in the health world, especially for pregnant women and their babies. It can cause both short-term and long-term health issues. Recently, the number of cases in our area has been increasing, which is concerning. So, it's important to find the best way to prevent this condition.
One way to do that is by following the Mediterranean Diet, which has been shown to improve things like reducing inflammation, making insulin work better, controlling blood sugar, and managing weight during pregnancy. A study found that when pregnant women followed this diet and got some extra help with olive oil and pistachios, the rate of GDM went down by more than 30%, from 28% to 17%. These positive results were also seen in real-life situations, where the rate stayed above 15%.
But here's the problem: not everyone can see a nutritionist early in their pregnancy, and sometimes, due to limited resources, the nutritional support from a nutritionist is stopped, which makes the GDM rate go up, even beyond 23%.
So, to tackle this issue, we've created a motivational video that explains how to live a healthy lifestyle during pregnancy, following the Mediterranean diet principles we mentioned earlier. Our plan is to show this video to pregnant women during their first checkup. We want to see if this video can make a difference in how many women develop GDM.
We'll study and compare the rates of GDM, how well the mothers and babies are doing, and some health measurements of women who watch our video and follow its advice versus those who stick to the standard pregnancy guidelines, which usually include diets provided by the obstetrician.
Who can participate?
Pregnant women at least 18 years old with normal fasting blood glucose values in the first gestational assessment
What does the study involve?
A Mediterranean diet plan will be given to all pregnant women visiting the hospital for their initial checkup between the 8th and 12th week of pregnancy.
To make sure this is done fairly, a random selection method has been chosen, using an online tool, for scheduling appointments with midwives, obstetricians, or family physicians. The healthcare professional will assign each woman to either the Control Group or the Intervention Group based on their appointment order.
If you're in the Intervention Group, you'll get a video with nutritional advice, created by a nutrition expert from the endocrinology department. You can watch it by scanning a QR code with your phone, and it's available for you throughout your pregnancy.
For those in the Control Group, you'll receive standard pregnancy information and dietary recommendations during your appointments, following the regular guidelines provided by your doctor. You can also discuss any questions or concerns during your in-person visits.
Both groups will continue with their regular checkups in the Obstetrics department and, if gestational diabetes is diagnosed, they'll also have follow-up visits in the Endocrinology department. These specific appointments include the 8-12 week visit, the 24-28 week visit for gestational diabetes screening, and visits between 28 and 38 weeks for ongoing care in case of GDM. Information about your pregnancy, childbirth, and newborn will be collected from hospital records after delivery.
What are the possible benefits and risks of participating?
A reduction in GDM and maternofoetal adverse outcomes will be expected associated with greater adherence to the MedDiet. No side effects are expected
Where is the study run from?
Hospital Clinico San Carlos (Hospital Clínico San Carlos) (Spain)
When is the study starting and how long is it expected to run for?
October 2023 to January 2025
Who is funding the study?
Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC) (Spain)
Who is the main contact?
Prof. Calle Pascual,
alfonsoluis.calle@salud.madrid.org
Contact information
Public, Scientific, Principal Investigator
Endocrinology and Nutrition Department
Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC)
Calle Profesor Martín Lagos s/n
Madrid
E-28040
Spain
 ORCID ID |
0000-0002-3628-9323 |
|---|---|
| Phone | +34 91 3303281 |
| alfonsoluis.calle@salud.madrid.org |
Study information
| Study design | Single centre clinic-based prospective randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 44524 PIS.pdf |
| Scientific title | The St Carlos video_MED_DIET Study |
| Study objectives | Early nutritional intervention based on an explanatory video of the lifestyle recommendations based on the principles of the Mediterranean diet at the first gestational visit, prior to week 8-12 of gestation, may improve adherence to the MED_DIET and to reduce GDM rate and other obstetric and neonatal complications, compared to standard treatment based on obstetrician/midwife/Family Physicians recommendations, by non-expert/specialized personnel in nutritional treatment |
| Ethics approval(s) |
Approved 20/10/2023, CEIC Hospital Clínico San Carlos (Calle Profesor Martín Lagos s/n Madrid Spain E28040, Madrid, 28040, Spain; +34 913303281; ceic.hcsc@salud.madrid.org), ref: 23.616-E_ |
| Health condition(s) or problem(s) studied | Gestational diabetes mellitus |
| Intervention | A nutritional intervention based on the Mediterranean diet will be given to all pregnant women attending the study hospital in the first gestational visit (gestational weeks 8 to 12). Due to the significant dispersion resulting from the decentralization of the first gestational visit to confirm pregnancy, a randomization method has been chosen in order of attendance at each consultation (online tool), The professional who performs it both midwife, obstetrician and/or family physicians, will consider inclusion 1 to 2 in Control Group or Intervention Group based on the order of appearance in the medical/ midwife consultation list. The women included in the intervention group will provide the nutritional/lifestyle intervention in explanatory motivational video format, carried out by an expert nutritionist from the endocrinology department (which they can obtain by reading a QR code with their phone) instead of the face-to-face visit with the nutritionist, titled: Pregnancy nutritional recommendations accessible at: https://youtu.be/Sg4fx4uls64 visible in QR that will be supplied to the pregnant woman. The video will be available to the pregnant woman throughout the pregnancy and can be consulted by her at any time. Women assigned to the Control group will receive information/recommendations during pregnancy as usual, providing different diets and the recommendations considered in the usual practical guidelines based on the provision of a set of diets written by the obstetrician in the consultation. They could make comments on each in-person visit as usual All participants for both study arms will have the usual follow-up visits in the Obstetrics department, and also in the Endocrinology department in case GDM is diagnosed. For this study, the following visits are specifically contemplated: -Visit 1 between 8-12 gestational weeks: Visit 2: Between 24-28 gestational weeks when GDM screening is performed according to IADPSG criteria -Visits between 28 and 38 GW if they are diagnosed with GDM for the usual follow up in the Endocrinology department. - Pregnancy/childbirth/newborn data will be collected from the hospital discharge records after delivery. |
| Intervention type | Behavioural |
| Primary outcome measure | Incidence of Gestational Diabetes Mellitus in each group diagnosed with a 75 g oral glucose load by IADPSG criteria at 24-28 gestational weeks |
| Secondary outcome measures | 1. Incidence of pre-eclampsia during pregnancy, as assessed using a blood pressure measurement and albuminuria in urine sample 2. Number of instrumental delivery and caesarean sections at birth, as assessed using obstetric medical records 3. Number of small for gestational age new-borns, macrosomic new-borns, and assessed using birth weight 4. Number of admissions to the paediatric intensive care unit at birth 5 Number of New-Borns before 37 gestational weeks 6. Weight gain is assessed weight at the 8-12 weeks gestational visit and the 38 gestational week visit and also by declared pregestational weight and that obtained at the 38 gestational week |
| Overall study start date | 01/10/2023 |
| Completion date | 31/01/2025 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 525 |
| Total final enrolment | 1656 |
| Key inclusion criteria | 1. Pregnant women at least 18 years old 2. Normal fasting blood glucose values in the first gestational assessment |
| Key exclusion criteria | 1. Women with fasting blood glucose >92 mg/dl in the first gestational assessment 2. Nuts or olive oil intolerance 3. Multiple pregnancy and any medical condition, treatment or diet intervention that the medical team considers to influence the effects of the study intervention. 4. Women with specific nutritional treatments |
| Date of first enrolment | 01/12/2023 |
| Date of final enrolment | 05/07/2024 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
E 28040
Spain
Sponsor information
Hospital/treatment centre
Calle Profesor Martín Lagos s/n
MADRID
E-28040
Spain
| Phone | +34 91 3303281 |
|---|---|
| fuinvest.hcsc@salud.madrid.org |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Results will be published in international diabetes journals and diabetes congress by the end of 2024 and 2025. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request alfonsoluis.calle@salud.madrid.org |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 02/11/2023 | No | Yes | ||
| Protocol file | 02/11/2023 | No | No | ||
| Statistical Analysis Plan | 02/11/2023 | No | No |
Additional files
Editorial Notes
19/02/2025: The following changes were made to the trial record:
1. The overall end date was changed from 17/01/2025 to 31/01/2025.
2. The intention to publish date was changed from 30/04/2025 to 30/06/2025.
3. The total final enrolment was changed from 1056 to 1656.
15/01/2025: The following changes were made to the study record:
1. The overall study end date was changed from 31/12/2024 to 17/01/2025.
2. The intention to publish date was changed from 31/12/2024 to 30/04/2025.
22/11/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2024 to 05/07/2024.
2. The total final enrolment was added.
02/11/2023: Trial's existence confirmed by CEIC Hospital Clínico San Carlos.
