Baby Bump Lifestyle Intervention Supplement Study (Baby BLISS)

The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.

Study Overview

• Status: Terminated
• Conditions: Gestational Diabetes
• Intervention / Treatment: Dietary supplement: Supplement

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • SUNY Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo supplement	Dietary supplement: Supplement; Supplement will be given to this group to take daily for 8 weeks
Experimental: Supplement; actual supplement	Dietary supplement: Supplement; Supplement will be given to this group to take daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lower blood stress markers via venous draw	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.	9 months

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: Baby BLISS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No