Maternal Loss of Control Eating

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT03269253

Collaborator

(none)

14,451

Enrollment

Location

11.6

Actual Duration (Months)

1246

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Eating Disorder Obesity

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

14451 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Maternal Loss of Control Eating: a Longitudinal Study of Maternal and Child Outcomes

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Jul 20, 2017

Actual Study Completion Date :

Jul 20, 2017

Outcome Measures

Primary Outcome Measures

birth weight [Day 1]
weight at birth

Secondary Outcome Measures

BMI [average 21 years]
body mass index
Food Frequency Questionnaire (FFQ) [average 9 months]
adult dietary patterns - software specific to the FFQ will be used to analyze data.
Food Frequency Questionnaire [average 21 years]
child dietary patterns- software specific to the FFQ will be used to analyze data.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

Principal Investigator: Nadia Micali, MD, PhD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT03269253

Other Study ID Numbers:

GCO 15-1668

First Posted:

Aug 31, 2017

Last Update Posted:

Aug 31, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Icahn School of Medicine at Mount Sinai

ALSPAC

longitudinal

Additional relevant MeSH terms:

Feeding and Eating Disorders

Study Results

No Results Posted as of Aug 31, 2017