Obesity, ChildhoodNCT04174521

Association Between Mother and Child Weight Gain: Statistical Methods With Validation

An observational study of Obesity, Childhood, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Using retrospective data from the Vanderbilt University Medical Center electronic health record, the investigators will study the association between mother's weight / weight change before and during pregnancy and the development of childhood obesity up until 5 years of age. Read more about this study

Who is it for?: Ages 0 years and older
Conditions the study is for: Obesity, Childhood
How many people: 20,670 participants
Where: 1 siteUnited States
Study dates: 26 Jun 2019to 1 Aug 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.

Who may be able to join

Mother-child pairs in the Vanderbilt University Medical Center (VUMC) electronic health record.
The mothers must have at least one height measurement.
The mothers must also have at least one weight measurement during pregnancy.
The child must have birth length and weight measures and at least one same day height/weight measurement during their first 5 years of life.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Read the detailed description

The investigators are extracting de-identified retrospective data from the Vanderbilt University Medical Center electronic health record for mother-child pairs. From this data, the investigators will study the association between mother weight change during pregnancy and the risk of her child developing obesity during the first 5 years of life. Included mothers must have at least one weight measurement and at least one height measurement; they must have at least one child with weight/length measurements at birth and one additional same day height/weight measurement at or before 5 years of age.

Conditions: Obesity, Childhood
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04174521
Study group	Role	What they receive
Mother-Child		Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.

What is being measured

The primary outcome is the main question the study is designed to answer.

Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life
Obesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles.
Measured: first 5 years of child's life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 20191 Aug 2021

First posted22 Nov 2019
Study start26 Jun 2019
Primary completion1 Aug 2021
Study completion1 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe 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: Retrospective
Enrolment: 20,670 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04174521
Sponsor's protocol ID: 190557
Status last verified: Jan 2022
First submitted: 20 Nov 2019
Last updated: 31 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
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Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity

All Obesity, Childhood trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association Between Mother and Child Weight Gain: Statistical Methods With Validation
ClinicalTrials.gov ID: NCT04174521
Acronym / sponsor ID: 190557
Conditions: Obesity, Childhood
Study type: Observational
Recruitment status: Completed
Enrolment: 20,670 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, University of Pennsylvania
Study start: 26 Jun 2019 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 1 Aug 2021 (actual)
First posted: 22 Nov 2019 (actual)
Results: Posted 31 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Mother-Child	–	–Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.

Who may qualify

Ages: 0 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.

Key inclusion criteria (4 listed)

Mother-child pairs in the Vanderbilt University Medical Center (VUMC) electronic health record.
The mothers must have at least one height measurement.
The mothers must also have at least one weight measurement during pregnancy.
The child must have birth length and weight measures and at least one same day height/weight measurement during their first 5 years of life.

Key exclusion criteria (0 listed)

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

Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life
Time frame: first 5 years of child's life
Obesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles.

Results and safety

Results posted to the registry on 31 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mother-Child	20,670	20,670

Primary outcome: Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life

Time frame: first 5 years of child's life. Count of participants. Unit: Participants

Measure	Mother-Child n = 10335
Value	1845

Adverse events

Time frame: Retrospective observational study; not applicable. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mother-Child	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): This was a retrospective observational study, and subject to all of the usual challenges with that type of data (e.g., confounding and measurement error). The data provided here are extracted from the electronic health record and may be prone to errors. We performed an extensive chart review for a subset of 996 mother-child records and incorporated these validated data into analyses using statistical methods that account for measurement error.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Obesity, Childhood

Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity

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.

Bryan Shepherd, PhD principal investigator

Vanderbilt University Medical Center

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 Obesity, Childhood, run by Vanderbilt University Medical Center 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 4 inclusion and 0 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 Jan 2022. 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?

Yes. Results are posted in the registry (first posted 31 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life (time frame: first 5 years of child's life). 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 NCT04174521.

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 Jan 2022.