CClinicalTrials.gg
CompletedNCT03269253Updated Aug 31, 2017

Maternal Loss of Control Eating

An observational study in Eating Disorder and Obesity, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to female participants aged 16 Years to 43 Years. Per ClinicalTrials.gov, last updated 2017-08-31.

Sponsored by Icahn School of Medicine at Mount Sinai · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
14,451
Ages
16 Years to 43 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Eating Disorder
  • Obesity

Keywords

  • ALSPAC
  • longitudinal
03

Who can participate

Ages eligible
16 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

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;

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
14,451 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. birth weight

    weight at birth

    Time frame: Day 1

Secondary outcomes

  1. BMI

    body mass index

    Time frame: average 21 years

  2. Food Frequency Questionnaire (FFQ)

    adult dietary patterns - software specific to the FFQ will be used to analyze data.

    Time frame: average 9 months

  3. Food Frequency Questionnaire

    child dietary patterns- software specific to the FFQ will be used to analyze data.

    Time frame: average 21 years

06

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
07

References and documents

Publications

  • Micali N, Al Essimii H, Field AE, Treasure J. Pregnancy loss of control over eating: a longitudinal study of maternal and child outcomes. Am J Clin Nutr. 2018 Jul 1;108(1):101-107. doi: 10.1093/ajcn/nqy040. PubMed 29873682 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03269253
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Aug 1, 2016
Primary completion
Jul 20, 2017
Completion
Jul 20, 2017
Last update
Aug 31, 2017

Study contacts

Nadia Micali, MD, PhD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

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

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

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