Baby Bump Lifestyle Intervention Supplement Study
Not Applicable
Terminated
- Conditions
- Gestational Diabetes
- Interventions
- Dietary Supplement: Supplement
- Registration Number
- NCT03751813
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
Inclusion Criteria
- Pregnant woman presenting to her first obstetrical visit for this pregnancy
- Must be in the first trimester (<13 weeks)
- 18 years or older
- High-stress levels as measured by the Perceived Stress Level Questionnaire
- Must be a single pregnancy (e.g. not twins, triplets, etc.)
Exclusion Criteria
- Diabetes (types 1 and 2)
- Diagnosis of gestational diabetes in prior pregnancy
- Hyperemesis gravidarum or severe morning sickness that interferes with supplement intake
- Major medical illnesses including but not limited to: malabsorption syndromes (Celiac's disease, Crohn's, Ulcerative Colitis), Systemic Lupus Erythematosus and other major autoimmune conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Supplement placebo supplement Supplement Supplement actual supplement
- Primary Outcome Measures
Name Time Method lower blood stress markers via venous draw 9 months We hypothesize that the addition of nutrients during gestation will decrease the levels of stress hormones/reactants in pregnant women who are at high risk for stressful pregnancies.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SUNY Buffalo
🇺🇸Buffalo, New York, United States