Phase
Condition
Obesity
Diabetes Prevention
Treatment
Weight Maintenance Group
Clinical Study ID
Ages 18-45 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Are pregnant less than or equal to 15 weeks gestation at screening
Have a body mass index between 31.0 and 55.0 inclusive
Have a confirmed viable singleton gestation
Willing to receive randomization to either group
Willing and able to eat the study foods
Willing to enroll infant for study measurements after birth
Receive clearance from the prenatal care provider for participation
Exclusion
Exclusion Criteria:
Smoking, drug, or alcohol use
Have a known fetal anomaly
Have a non-pregnancy related illness
Have pre-existing diabetes
Have pre-existing hypertension
Have severe anemia
Have current mental health issue or eating disorder
Short inter-pregnancy interval (<6 months since last pregnancy)
Use of assisted reproductive technology
Use of medications with known effects on body weight including over the countermedications and supplements for weight loss
History of pre-eclampsia, prior small for gestational age infant, bariatric surgery
Planning to move out of the area in the next 12 months
Study Design
Study Description
Connect with a study center
California Polytechnic State University
San Luis Obispo, California 93407
United StatesActive - Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
United StatesActive - Recruiting
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