- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07508709
Personalized Nutrition During Pregnancy
March 30, 2026 updated by: Olivia Sher
Examining the Effect of Hyper-personalized Nutrition Advice for OBGYN Patients on Health and Wellbeing Outcomes During and After Pregnancy
Dietary quality and total energy intake during pregnancy significantly influences the mother's health during pregnancy and that of the fetus as well as decade long influences on the health outcomes of the child.
However, a one size fits all approach to nutritional guidance is far from ideal given the unique biological, lifestyle, demographic, and health condition differences of expecting mothers.
This research proposal will examine the effect of precision nutrition on the health and wellbeing outcomes of mothers during pregnancy, at the time of delivery, and post-delivery.
Personal nutritional guidance is based on personal biological, behavioral, and health data.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Participants will be recruited out of the Maimonides Women's Health Clinic.
Each arm will recruit 75 participants.
The intervention arm will receive a DNA swab which will be tested and then the patient will receive DNA specific nutrition advice on their smartphone via nine moons app.
The other arm will receive no intervention and will only receive standard nutritional advice.
Both arms will be followed up every 4 weeks to test vitals and height and weight.
Delivery outcomes will be compared at the end of pregnancy.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11220
- Women's Primary Care Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pregnant women are less then 20 weeks gestation
Exclusion Criteria:
- High-risk patients with severe obesity (BMI >35), existing pre-conditions such as diabetes, hypertension, cardiac abnormalities, and need for special medical attention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutrition intervention
|
Individuals in the intervention arm will receive DNA specific nutritional advice on the nine moons app during pregnancy
|
|
No Intervention: standard nutrition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of cesarean section vs. normal vaginal delivery
Time Frame: 9 months
|
c-section rate
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2022
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
March 15, 2024
Study Registration Dates
First Submitted
December 6, 2022
First Submitted That Met QC Criteria
March 30, 2026
First Posted (Actual)
April 2, 2026
Study Record Updates
Last Update Posted (Actual)
April 2, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-03-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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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