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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03269253
Other study ID # GCO 15-1668
Secondary ID
Status Completed
Phase N/A
First received August 29, 2017
Last updated August 29, 2017
Start date August 1, 2016
Est. completion date July 20, 2017

Study information

Verified date August 2017
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study focused on investigating the effects of maternal disordered eating on maternal and child outcomes as part of a secondary data analysis of the Avon Longitudinal Study of Parents and Children (ALSPAC).


Description:

Deidentified and anonymised data already collected as part of the ALSPAC study will be analysed to investigate the effects of maternal eating on maternal and child outcomes (diet, eating, weight, metabolic). The Avon Longitudinal Study of Parents and Children (ALSPAC) is a longitudinal, prospective study designed to examine the effects of environment, genetics and other factors on health and development.All pregnant women living in the geographical area of Avon, UK, who were expected to deliver their baby between 1st April 1991 and 31st December 1992, were recruited. 14,541 women were enrolled. Amongst these pregnancies, there were a total of 14,676 fetuses, resulting in 14,062 live births and 13,798 children who were alive at 1 year of age and were singletons. The ALSPAC study website contains details of all the data that is available through a fully searchable data Dictionary (http://www.bris.ac.uk/alspac/researchers/data-access/data-dictionary/).

Missingness will be assessed and standard data analytical techniques such as MI will be used.Crude and adjusted logistic, linear, and multinomial regression models will be employed.


Recruitment information / eligibility

Status Completed
Enrollment 14451
Est. completion date July 20, 2017
Est. primary completion date July 20, 2017
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 43 Years
Eligibility Inclusion Criteria:

Exclusion Criteria:

- multiple pregnancies

- no questionnaire data at 32 weeks.

eligibility criteria : enrolled in the ALSPAC study; inclusion: all women part of the ALSPAC study;

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary birth weight weight at birth Day 1
Secondary BMI body mass index average 21 years
Secondary Food Frequency Questionnaire (FFQ) adult dietary patterns - software specific to the FFQ will be used to analyze data. average 9 months
Secondary Food Frequency Questionnaire child dietary patterns- software specific to the FFQ will be used to analyze data. average 21 years
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