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Baby Bump Lifestyle Intervention Supplement Study

Baby Bump Lifestyle Intervention Supplement Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03751813
Acronym
Baby BLISS
Enrollment
4
Registered
2018-11-23
Start date
2019-03-21
Completion date
2019-11-30
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

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.

Interventions

DIETARY_SUPPLEMENTSupplement

Supplement will be given to this group to take daily for 8 weeks

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
lower blood stress markers via venous draw9 monthsWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026