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COMPLETED
NCT03244722
NA

Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes

Sponsor: University of Michigan

View on ClinicalTrials.gov

Summary

Our hypothesis is that aggressive preconception weight loss in obese women will improve the metabolic health of the mother and the intrauterine environment. An optimized developmental environment will normalize fetal growth and improve clinical fetal and infant outcomes, and theoretically reduce future susceptibility to obesity and cardiometabolic disease.

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

147

Start Date

2018-04-10

Completion Date

2025-08-29

Last Updated

2026-09-04

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Very-low energy Diet (VLED)

Structured, intensive dietary intervention using liquid meal replacements aimed at providing 800 kcal/day with a weight loss goal of 15% from baseline

OTHER

Standard of care (SOC)

Standard consultation with registered dietitian to determine appropriate caloric deficit for a low calorie diet, education and advice to achieve weight loss in obese women. Standard of care for normal weight women

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States