Eating BehaviorNCT03239028
Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy
An observational study of Eating Behavior, run by Centre for Fetal Programming, Denmark.
Trial summary
We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort Read more about this study
- Who is it for?
- Ages 14 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Observational
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19,620 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Aug 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 14 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Around 95,000 children born during 1996-2003 in Denmark were recruited for The Danish National Birth Cohort
Who may be able to join
- Participants in the Danish National Birth Cohort
Who cannot join
- If mother did not complete a food frequency questionnaire during pregnancy
About this study
Official title: Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy: 15 Years Follow up From a Large National Birth Cohort
We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort
Read the detailed description
Background: Dietary exposures in fetal life may have long lasting impact on the individual's susceptibility for several non-communicable diseases. Although offspring's own dietary habits become increasingly independent from parental influence other external factors are likely to exist. Further insights are needed to interpret and separate potential influence from exposures in pregnancy from later dietary habits on later disease risk.
Objectives: We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort (DNBC).
Design: A total of 19620 DNBC offspring-mother pairs will be matched by offspring dietary intake assessed at age ~14 years with a 150-item food frequency questionnaire (FFQ) and dietary intake assessed with a 300-item FFQ during mid-pregnancy (1996-2003). A Healthy Eating Index (HEI) will be developed as an indicator for diet quality based on current Danish Food-Based Dietary Guidelines including 8 components; fruit and vegetables, fish, dietary fibers, red meat, saturated fatty acids, sodium, sugar-sweetened beverages, and added sugar.
- Conditions
- Eating Behavior
- Being tested
- Observational
- Keywords
- diet quality, pregnancy, adolescence, longitudinal study, food frequency questionnaire
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Danish National Birth Cohort | Not described Receives: Behavioral: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet quality
Healthy Eating Index depicting diet quality
Measured: Reported intake during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion1 Aug 2017
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 Eating BehaviorStudies 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
- 19,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Fetal Programming, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, University of Iceland, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Sjurdur F Olsen, PhD, Study director, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239028
- Sponsor's protocol ID
- 2013-04 M-C Association
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Olsen J, Melbye M, Olsen SF, Sorensen TI, Aaby P, Andersen AM, Taxbol D, Hansen KD, Juhl M, Schow TB, Sorensen HT, Andresen J, Mortensen EL, Olesen AW, Sondergaard C. The Danish National Birth Cohort--its background, structure and aim. Scand J Public Health. 2001 Dec;29(4):300-7. doi: 10.1177/14034948010290040201.
PubMed 11775787Olsen SF, Mikkelsen TB, Knudsen VK, Orozova-Bekkevold I, Halldorsson TI, Strom M, Osterdal ML. Data collected on maternal dietary exposures in the Danish National Birth Cohort. Paediatr Perinat Epidemiol. 2007 Jan;21(1):76-86. doi: 10.1111/j.1365-3016.2007.00777.x.
PubMed 17239183
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy: 15 Years Follow up From a Large National Birth Cohort
- ClinicalTrials.gov ID
- NCT03239028
- Acronym / sponsor ID
- 2013-04 M-C Association
- Conditions
- Eating Behavior
- Keywords
- diet quality, pregnancy, adolescence, longitudinal study, food frequency questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,620 participants (actual)
- Lead sponsor
- Centre for Fetal Programming, DenmarkUniversity, hospital or other
- Collaborators
- Statens Serum Institut, University of Iceland, University of Copenhagen
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 3 Aug 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.
We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort
Detailed description
Background: Dietary exposures in fetal life may have long lasting impact on the individual's susceptibility for several non-communicable diseases. Although offspring's own dietary habits become increasingly independent from parental influence other external factors are likely to exist. Further insights are needed to interpret and separate potential influence from exposures in pregnancy from later dietary habits on later disease risk.
Objectives: We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort (DNBC).
Design: A total of 19620 DNBC offspring-mother pairs will be matched by offspring dietary intake assessed at age ~14 years with a 150-item food frequency questionnaire (FFQ) and dietary intake assessed with a 300-item FFQ during mid-pregnancy (1996-2003). A Healthy Eating Index (HEI) will be developed as an indicator for diet quality based on current Danish Food-Based Dietary Guidelines including 8 components; fruit and vegetables, fish, dietary fibers, red meat, saturated fatty acids, sodium, sugar-sweetened beverages, and added sugar.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Danish National Birth Cohort | – | Behavioral: Observational |
Who may qualify
- Ages
- 14 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Around 95,000 children born during 1996-2003 in Denmark were recruited for The Danish National Birth Cohort
Key inclusion criteria (1 listed)
- Participants in the Danish National Birth Cohort
Key exclusion criteria (1 listed)
- If mother did not complete a food frequency questionnaire during pregnancy
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 |
|---|---|---|
| Observational | Behavioural | Danish National Birth Cohort |
Primary outcome
Diet quality
Time frame: Reported intake during one year
Healthy Eating Index depicting diet quality
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 3 Aug 2017.
- Results publication: PubMed 11775787Olsen J, Melbye M, Olsen SF, Sorensen TI, Aaby P, Andersen AM, Taxbol D, Hansen KD, Juhl M, Schow TB, Sorensen HT, Andresen J, Mortensen EL, Olesen AW, Sondergaard C. The Danish National Birth Cohort--its background, structure and aim. Scand J Public Health. 2001 Dec;29(4):300-7. doi: 10.1177/14034948010290040201.
- Results publication: PubMed 17239183Olsen SF, Mikkelsen TB, Knudsen VK, Orozova-Bekkevold I, Halldorsson TI, Strom M, Osterdal ML. Data collected on maternal dietary exposures in the Danish National Birth Cohort. Paediatr Perinat Epidemiol. 2007 Jan;21(1):76-86. doi: 10.1111/j.1365-3016.2007.00777.x.
- Link to web-page of Centre for Fetal ProgrammingLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sjurdur F Olsen, PhD study director
Statens Serum Institut
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Behavior, run by Centre for Fetal Programming, Denmark.
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 1 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: finished, as of the sponsor's last update on 3 Aug 2017. 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?
Diet quality (time frame: Reported intake during one year). 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 NCT03239028, 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 3 Aug 2017.