Cardiometabolic RiskNCT03274739
Maternal Diet, Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood
An observational study of Cardiometabolic Risk and Growth, run by Barcelona Institute for Global Health.
Trial summary
This study focused on evaluating the association between adherence to the Mediterranean diet during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic risk in early-childhood. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk, Growth, Childhood Obesity
- How many people
- 2,762 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to 18 Jan 2017
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study included pregnant women recruited between 2003 and 2008 in the four Spanish regions of Asturias, Gipuzkoa, Sabadell and Valencia as part of the population-based INMA ("INfancia y Medio Ambiente") birth cohort study. The pregnant women were recruited during prenatal visits in the 1st trimester of pregnancy at public health care centers or hospitals. Mothers were afterwards followed at 3rd trimester, and their children later, and at ages 6 months, 1 and 4 years.
Who may be able to join
- to be resident in one of the study areas
- to be at least 16 years old
- to have a singleton pregnancy
- to wish to deliver in the reference hospital
Who cannot join
- to not be fluent in Spanish or other regional languages.
- to have followed a programme of assisted reproduction
About this study
Official title: Maternal Mediterranean Diet During Pregnancy in Association to Longitudinal Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood
This study focused on evaluating the association between adherence to the Mediterranean diet during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic risk in early-childhood. This study is part of a secondary data analysis of the INMA (INfancia y Medio Ambiente-(Environment and Childhood)) Project.
- Conditions
- Cardiometabolic Risk, Growth, Childhood Obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Offspring's body mass index z-score trajectories
Measured: From birth to 4 years of age
Child cardiometabolic risk score
Measured: At 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study startFeb 2004
- Primary completionDec 2012
- Study completion18 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic RiskStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Virgili, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274739
- Sponsor's protocol ID
- Creal
- Status last verified
- Apr 2023
- First submitted
- 5 Sep 2017
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guxens M, Ballester F, Espada M, Fernandez MF, Grimalt JO, Ibarluzea J, Olea N, Rebagliato M, Tardon A, Torrent M, Vioque J, Vrijheid M, Sunyer J; INMA Project. Cohort Profile: the INMA--INfancia y Medio Ambiente--(Environment and Childhood) Project. Int J Epidemiol. 2012 Aug;41(4):930-40. doi: 10.1093/ije/dyr054. Epub 2011 Apr 5. No abstract available.
PubMed 21471022
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Mediterranean Diet During Pregnancy in Association to Longitudinal Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood
- ClinicalTrials.gov ID
- NCT03274739
- Acronym / sponsor ID
- Creal
- Conditions
- Cardiometabolic Risk, Growth, Childhood Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,762 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Study start
- Feb 2004 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 7 Sep 2017 (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.
This study focused on evaluating the association between adherence to the Mediterranean diet during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic risk in early-childhood. This study is part of a secondary data analysis of the INMA (INfancia y Medio Ambiente-(Environment and Childhood)) Project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Pregnant women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included pregnant women recruited between 2003 and 2008 in the four Spanish regions of Asturias, Gipuzkoa, Sabadell and Valencia as part of the population-based INMA ("INfancia y Medio Ambiente") birth cohort study. The pregnant women were recruited during prenatal visits in the 1st trimester of pregnancy at public health care centers or hospitals. Mothers were afterwards followed at 3rd trimester, and their children later, and at ages 6 months, 1 and 4 years.
Key inclusion criteria (4 listed)
- to be resident in one of the study areas
- to be at least 16 years old
- to have a singleton pregnancy
- to wish to deliver in the reference hospital
Key exclusion criteria (2 listed)
- to not be fluent in Spanish or other regional languages.
- to have followed a programme of assisted reproduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Offspring's body mass index z-score trajectories
Time frame: From birth to 4 years of age
Child cardiometabolic risk score
Time frame: At 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 21471022Guxens M, Ballester F, Espada M, Fernandez MF, Grimalt JO, Ibarluzea J, Olea N, Rebagliato M, Tardon A, Torrent M, Vioque J, Vrijheid M, Sunyer J; INMA Project. Cohort Profile: the INMA--INfancia y Medio Ambiente--(Environment and Childhood) Project. Int J Epidemiol. 2012 Aug;41(4):930-40. doi: 10.1093/ije/dyr054. Epub 2011 Apr 5. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiometabolic Risk and Growth, run by Barcelona Institute for Global Health.
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 2 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: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Offspring's body mass index z-score trajectories (time frame: From birth to 4 years of age). The study lists 2 primary outcomes in all. 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 NCT03274739, which also lists 1 linked publication.
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 20 Apr 2023.