Preconception Maternal Nutrition and Obesity and Impact on Fetal Outcomes, Child Health and Weight
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 10/6/2018 |
| Start Date: | April 10, 2018 |
| End Date: | July 2022 |
| Contact: | Shannon Considine, MPH, MSW |
| Email: | sconsidi@umich.edu |
| Phone: | 734-232-6483 |
Effects of a Preconception Intervention for Obese Women on Reproductive, Maternal, Fetal, and Child Weight and Health Outcomes
This study attempts to understand the association between maternal weight and child weight.
Intended participants are both obese and lean women looking to get pregnant in the near
future. Obese participants will be randomized to either a structured very low calorie diet or
standard-of-care pre-natal dietary counseling. Lean participants will receive
standard-of-care pre-natal dietary counseling. From pre-pregnancy through one-year after
delivery, both mom and child will participate in tests looking at how their bodies process
and store energy. Our hypothesis is that we affect the maternal-child weight association by
changing the mother's pre-pregnancy metabolic make up.
Intended participants are both obese and lean women looking to get pregnant in the near
future. Obese participants will be randomized to either a structured very low calorie diet or
standard-of-care pre-natal dietary counseling. Lean participants will receive
standard-of-care pre-natal dietary counseling. From pre-pregnancy through one-year after
delivery, both mom and child will participate in tests looking at how their bodies process
and store energy. Our hypothesis is that we affect the maternal-child weight association by
changing the mother's pre-pregnancy metabolic make up.
Inclusion Criteria:
- BMI > 30 ≤ 45 for obese participants OR
- BMI ≤ 25 for healthy body weight participants
- No known infertility
- No known risk factors for tubal disease
Exclusion Criteria:
- Significant medical co-morbidities (e.g. heart, kidney, liver, autoimmune disease)
- Significant anemia
- Cancer other than minor skin cancers
- Conditions that would complicate pregnancy
- Recent use of anti-obesity drugs or appetite suppressants
- Previous bariatric surgery
- Endometriosis AFS (American Fertility Society classification class III or IV)
- Progesterone > 10 IU/ml
- Current pregnancy
- Use of sperm donor
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