Personalized Nutrition During Pregnancy

NCT07508709 | Withdrawn FDA Device

• 1 other identifier: 2022-03-15
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition, Healthy; Nutrition Poor; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Rate of cesarean section vs. normal vaginal delivery

  c-section rate

  9 months

Study Arms (2)

Nutrition intervention

EXPERIMENTAL

Other: Ninemoons app

standard nutrition

NO INTERVENTION

Interventions

Ninemoons app OTHER

Individuals in the intervention arm will receive DNA specific nutritional advice on the nine moons app during pregnancy

Nutrition intervention

Eligibility Criteria

• Age: 18 Years - 62 Years
• Gender Eligibility Details: must be pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women are less then 20 weeks gestation

You may not qualify if:

• High-risk patients with severe obesity (BMI \>35), existing pre-conditions such as diabetes, hypertension, cardiac abnormalities, and need for special medical attention

Sponsors & Collaborators

• Olivia Sher: lead

Study Sites (1)

Women's Primary Care Clinic

Brooklyn, New York, 11220, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: April 2, 2026
• Study Start: December 18, 2022
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)