Dietary Quality During Adolescence is Associated With Mot... | NCT03239028

Studies
Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy

NCT03239028

Sponsor

Centre for Fetal Programming, Denmark

Status

Completed

Last Update Posted

Aug 3, 2017Actual

Enrollment

19,620Actual

Phase

Not provided

Conditions

Eating Behavior

Interventions

Observational

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

Aug 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, 2016Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Aug 1, 2017Actual

First Submitted Date

Aug 1, 2017

First Submission Date that Met QC Criteria

Aug 1, 2017

First Posted Date

Aug 3, 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

Aug 1, 2017

Last Update Posted Date

Aug 3, 2017Actual

Name	Class
Statens Serum Institut	OTHER
University of Iceland	OTHER
University of Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

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

19,620Actual

Label	Type	Description	Intervention Names
Danish National Birth Cohort			Behavioral: Observational

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diet quality	Healthy Eating Index depicting diet quality	Reported intake during one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants in the Danish National Birth Cohort

Exclusion Criteria:

If mother did not complete a food frequency questionnaire during pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Around 95,000 children born during 1996-2003 in Denmark were recruited for The Danish National Birth Cohort

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sjurdur F Olsen, PhD	Statens Serum Institut	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11775787	Result	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.
17239183	Result

ID	Term
D001522	Behavior, Animal
D001519	Behavior

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration