Eating DisorderNCT03269253
Maternal Loss of Control Eating
An observational study of Eating Disorder and Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 16 to 43 years, women only
- Conditions the study is for
- Eating Disorder, Obesity
- How many people
- 14,451 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 20 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 43 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- -
Who cannot join
- multiple pregnancies
- no questionnaire data at 32 weeks.
- eligibility criteria : enrolled in the ALSPAC study; inclusion: all women part of the ALSPAC study;
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Maternal Loss of Control Eating: a Longitudinal Study of Maternal and Child Outcomes
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.
- Conditions
- Eating Disorder, Obesity
- Keywords
- ALSPAC, longitudinal
- Medical subject headings
- Feeding and Eating Disorders, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
birth weight
weight at birth
Measured: Day 1
Secondary outcomes (3)
BMI
body mass index
Measured: average 21 years
Food Frequency Questionnaire (FFQ)
adult dietary patterns - software specific to the FFQ will be used to analyze data.
Measured: average 9 months
Food Frequency Questionnaire
child dietary patterns- software specific to the FFQ will be used to analyze data.
Measured: average 21 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Aug 2016
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Micali, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269253
- Sponsor's protocol ID
- GCO 15-1668
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Loss of Control Eating: a Longitudinal Study of Maternal and Child Outcomes
- ClinicalTrials.gov ID
- NCT03269253
- Acronym / sponsor ID
- GCO 15-1668
- Conditions
- Eating Disorder, Obesity
- Keywords
- ALSPAC, longitudinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,451 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (3 listed)
- multiple pregnancies
- no questionnaire data at 32 weeks.
- eligibility criteria : enrolled in the ALSPAC study; inclusion: all women part of the ALSPAC study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
birth weight
Time frame: Day 1
weight at birth
3 secondary outcomes
BMI
Time frame: average 21 years
Food Frequency Questionnaire (FFQ)
Time frame: average 9 months
Food Frequency Questionnaire
Time frame: average 21 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Derived from this study: PubMed 29873682Micali 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Micali, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorder and Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
birth weight (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.