Breastfeeding and Complementary Feeding in Relation to BM... | NCT03334760

Studies
Breastfeeding and Complementary Feeding in Relation to BMI and Overweight

NCT03334760

Sponsor

University Hospital Bispebjerg and Frederiksberg

Status

Completed

Last Update Posted

Nov 8, 2017Actual

Enrollment

100,418Actual

Phase

Not provided

Conditions

Child Overweight

Interventions

Danish National Birth Cohort

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Nov 1, 2017Actual

Completion Date

Nov 1, 2017Actual

First Submitted Date

Nov 3, 2017

First Submission Date that Met QC Criteria

Nov 3, 2017

First Posted Date

Nov 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

Name	Class
University of Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100,418Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Danish National Birth Cohort	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child overweight	The parent reported the height and weight of the children at approximately 7 and 11 years of age.	2003-2014

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Women who were not pregnant.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29566190	Derived	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.

ID	Term
D050177	Overweight
D001942	Breast Feeding

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight