Trial Summary
What is the purpose of this trial?
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.
Research Team
AR
Amy Rothberg, MD, PhD
Principal Investigator
University of Michigan
Eligibility Criteria
This trial is for obese women with a BMI between 30 and 45 who want to lose weight before getting pregnant. They should not have infertility issues, significant medical conditions, or a history of certain treatments like bariatric surgery. Healthy-weight women with a BMI up to 25 can also join.Inclusion Criteria
BMI > 30 ≤ 45 for obese participants
BMI ≤ 25 for healthy body weight participants
No known risk factors for tubal disease
Exclusion Criteria
My endometriosis is classified as severe.
Current pregnancy
Conditions that would complicate pregnancy
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Treatment Details
Interventions
- Very-low energy Diet (VLED) (Dietary Supplement)
Trial OverviewThe study tests if losing weight through a Very-low energy Diet (VLED) before conception leads to better health for the mother and baby compared to standard care. It aims to see if this improves birth outcomes and reduces future obesity risks in children.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Obese - Very low energy diet (VLED)Experimental Treatment1 Intervention
Participants will adopt a very-low energy diet
Group II: Obese - Standard of care (SOC)Experimental Treatment1 Intervention
Participants will receive the standard of care for obese women looking to become pregnant.
Group III: Lean - Standard of care (SOC)Experimental Treatment1 Intervention
Participants will receive the standard of care for lean women looking to become pregnant.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Trials
1891
Patients Recruited
6,458,000+
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Trials
2513
Patients Recruited
4,366,000+