Child OverweightNCT03334760
Breastfeeding and Complementary Feeding in Relation to BMI and Overweight
An observational study of Child Overweight, run by University Hospital Bispebjerg and Frederiksberg.
Trial summary
This study examines the associations between different types of infant feeding and BMI and overweight in childhood. The study is based on the Danish National Birth Cohort, established in 1996. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Overweight
- What is being tested?
- Danish National Birth Cohort
- How many people
- 100,418 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Nov 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 DNBC was established during the years 1996 to 2003. A total of 100,418 pregnancies among a total of 92,274 women were enrolled into the cohort from all over Denmark. The women were invited at their first antenatal visit at the general practitioner. It is estimated that approximately 30% of all pregnant women in Denmark participated in the DNBC and the response rate is estimated to be 60%.The women were interviewed by telephone twice during their pregnancy, in approximately gestational week 16 (interview 1) and 31 (interview 2), and twice after their pregnancy when the child was approximately 6 (interview 3) and 18 months old (interview 4). During the computer assisted telephone interviews, the women gave detailed information on their physical and mental health, life style, nutrition and medicine use, and in the post-partum interviews the women gave information on growth, health and nutrition of the children.
Who may be able to join
- The women were invited at their first antenatal visit at the general practitioner.Women were included if they intended to carry the pregnancy to term, had a permanent address in Denmark, and spoke Danish well enough to participate in telephone interviews.
Who cannot join
- Women who were not pregnant.
About this study
Official title: Breastfeeding and Complementary Feeding in Relation to BMI and Overweight at Ages 7 and 11 Years - a Path Analysis Within the Danish National Birth Cohort
This study examines the associations between different types of infant feeding and BMI and overweight in childhood. The study is based on the Danish National Birth Cohort, established in 1996.
Read the detailed description
The objective of the study is to examine whether duration of breastfeeding, timing of introduction of complementary food and protein intake at 18 months are associated with BMI and overweight at ages 7 and 11 years, independent of BMI during infancy.
Children participating in the Danish National Birth Cohort were followed-up at ages 7 and 11years. Information on infant feeding, protein intake at 18 months, Ponderal Index at birth, child BMI (5 months, 12 months, 7 and 11 years) and several parental factors was available.
Path analysis was used to assess the direct and indirect effects of infant feeding on BMI z-scores at ages 7 (n= 36,481) and 11y (n=22,047). Logistic regression analyses were used to examine associations with overweight.
- Conditions
- Child Overweight
- Being tested
- Danish National Birth Cohort
- Keywords
- Cohort study, Infant feeding, Overweight, Child BMI, Breastfeeding, Intake of protein
- Medical subject headings
- Overweight, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danish National Birth CohortOther
DNBC is a nationwide cohort study of pregnant women and their offspring. The women were enrolled early during pregnancy between 1996 and 2002. They provided information on exposures during and after pregnancy by means of four computer-assisted telephone interviews in gestational weeks 12 and 30 and post-partum when the child was 6 and 18 months old.
What is being measured
The primary outcome is the main question the study is designed to answer.
Child overweight
The parent reported the height and weight of the children at approximately 7 and 11 years of age.
Measured: 2003-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Jan 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 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 Child OverweightStudies 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
- 100,418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Camilla Schmidt Morgen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334760
- Sponsor's protocol ID
- UHBispebjergFrederiksberg
- Status last verified
- Nov 2017
- First submitted
- 3 Nov 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, the data from the DNBC may be shared.
Publications
Morgen CS, Angquist L, Baker JL, Andersen AN, Sorensen TIA, Michaelsen KF. Breastfeeding and complementary feeding in relation to body mass index and overweight at ages 7 and 11 y: a path analysis within the Danish National Birth Cohort. Am J Clin Nutr. 2018 Mar 1;107(3):313-322. doi: 10.1093/ajcn/nqx058.
PubMed 29566190
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding and Complementary Feeding in Relation to BMI and Overweight at Ages 7 and 11 Years - a Path Analysis Within the Danish National Birth Cohort
- ClinicalTrials.gov ID
- NCT03334760
- Acronym / sponsor ID
- UHBispebjergFrederiksberg
- Conditions
- Child Overweight
- Keywords
- Cohort study, Infant feeding, Overweight, Child BMI, Breastfeeding, Intake of protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,418 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 7 Nov 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 examines the associations between different types of infant feeding and BMI and overweight in childhood. The study is based on the Danish National Birth Cohort, established in 1996.
Detailed description
The objective of the study is to examine whether duration of breastfeeding, timing of introduction of complementary food and protein intake at 18 months are associated with BMI and overweight at ages 7 and 11 years, independent of BMI during infancy.
Children participating in the Danish National Birth Cohort were followed-up at ages 7 and 11years. Information on infant feeding, protein intake at 18 months, Ponderal Index at birth, child BMI (5 months, 12 months, 7 and 11 years) and several parental factors was available.
Path analysis was used to assess the direct and indirect effects of infant feeding on BMI z-scores at ages 7 (n= 36,481) and 11y (n=22,047). Logistic regression analyses were used to examine associations with overweight.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The DNBC was established during the years 1996 to 2003. A total of 100,418 pregnancies among a total of 92,274 women were enrolled into the cohort from all over Denmark. The women were invited at their first antenatal visit at the general practitioner. It is estimated that approximately 30% of all pregnant women in Denmark participated in the DNBC and the response rate is estimated to be 60%.The women were interviewed by telephone twice during their pregnancy, in approximately gestational week 16 (interview 1) and 31 (interview 2), and twice after their pregnancy when the child was approximately 6 (interview 3) and 18 months old (interview 4). During the computer assisted telephone interviews, the women gave detailed information on their physical and mental health, life style, nutrition and medicine use, and in the post-partum interviews the women gave information on growth, health and nutrition of the children.
Key inclusion criteria (1 listed)
- The women were invited at their first antenatal visit at the general practitioner.Women were included if they intended to carry the pregnancy to term, had a permanent address in Denmark, and spoke Danish well enough to participate in telephone interviews.
Key exclusion criteria (1 listed)
- Women who were not pregnant.
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 |
|---|---|---|
| Danish National Birth CohortDNBC is a nationwide cohort study of pregnant women and their offspring. The women were enrolled early during pregnancy between 1996 and 2002. They provided information on exposures during and after pregnancy by means of four computer-assisted telephone interviews in gestational weeks 12 and 30 and post-partum when the child was 6 and 18 months old. | Other | – |
Primary outcome
Child overweight
Time frame: 2003-2014
The parent reported the height and weight of the children at approximately 7 and 11 years of age.
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 8 Nov 2017.
- Derived from this study: PubMed 29566190Morgen CS, Angquist L, Baker JL, Andersen AN, Sorensen TIA, Michaelsen KF. Breastfeeding and complementary feeding in relation to body mass index and overweight at ages 7 and 11 y: a path analysis within the Danish National Birth Cohort. Am J Clin Nutr. 2018 Mar 1;107(3):313-322. doi: 10.1093/ajcn/nqx058.
- Individual participant dataSharing planned: Yes. Upon request, the data from the DNBC may be shared.
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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 Child Overweight, run by University Hospital Bispebjerg and Frederiksberg.
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 8 Nov 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?
Child overweight (time frame: 2003-2014). 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 NCT03334760, 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 8 Nov 2017.