Baby Bump Lifestyle Intervention Supplement Study

NCT ID: NCT03751813

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2019-11-30

Brief Summary

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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

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Placebo

placebo supplement

Group Type PLACEBO_COMPARATOR

Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Supplement

actual supplement

Group Type EXPERIMENTAL

Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Kai Ling Kong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SUNY Buffalo

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Baby BLISS

Identifier Type: -

Identifier Source: org_study_id

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