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CompletedNCT03334760Updated Nov 8, 2017

Breastfeeding and Complementary Feeding in Relation to BMI and Overweight

An observational study in Child Overweight, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-08.

Sponsored by University Hospital Bispebjerg and Frederiksberg · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100,418
Sex
Female
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Study 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 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.

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Conditions studied

  • Child Overweight

Keywords

  • Cohort study
  • Infant feeding
  • Overweight
  • Child BMI
  • Breastfeeding
  • Intake of protein
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In context

Overweight

3,604 studies on the registry are indexed under Overweight; 853 are open to participants now.

This study's enrollment of 100,418 is above the median of 154 across 425 observational studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 69 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Women who were not pregnant.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100,418 participants (actual)
Patient registry
No

Interventions

  • OtherDanish National Birth Cohort

    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.

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What researchers measure

Primary outcomes

  1. Child overweight

    The parent reported the height and weight of the children at approximately 7 and 11 years of age.

    Time frame: 2003-2014

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Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Upon request, the data from the DNBC may be shared.

Supporting information: Study protocol, Statistical analysis plan

Time frame: The data are available.

Access criteria: Researchers can apply the DNBC steering committee for data access.

Data sharing details ↗ · www.ssi.dk

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Nov 2017, 10 months.

Of 152 non-industry observational studies under Overweight, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 121. This study's 10 months is below that.

Counting every sponsor, half of 169 studies reached it within 37 months; a quarter within 15 and three quarters within 91.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2017
First posted
Nov 7, 2017
StartActual
Jan 1, 2017
Primary completionActual
Nov 1, 2017
CompletionActual
Nov 1, 2017
Last update
Nov 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03334760
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Responsible party
Camilla Schmidt Morgen (Project coordinator and primary investigator, University Hospital Bispebjerg and Frederiksberg) — Principal investigator
First posted
Nov 7, 2017
Start date
Jan 1, 2017
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Nov 8, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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