- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03269253
Maternal Loss of Control Eating
Maternal Loss of Control Eating: a Longitudinal Study of Maternal and Child Outcomes
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
birth weight
Time Frame: Day 1
|
weight at birth
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: average 21 years
|
body mass index
|
average 21 years
|
|
Food Frequency Questionnaire (FFQ)
Time Frame: average 9 months
|
adult dietary patterns - software specific to the FFQ will be used to analyze data.
|
average 9 months
|
|
Food Frequency Questionnaire
Time Frame: average 21 years
|
child dietary patterns- software specific to the FFQ will be used to analyze data.
|
average 21 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nadia Micali, MD, PhD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 15-1668
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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