search
Back to results

Baby Bump Lifestyle Intervention Supplement Study (Baby BLISS)

Primary Purpose

Gestational Diabetes

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supplement
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • SUNY Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Supplement

Arm Description

placebo supplement

actual supplement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2018
Last Updated
February 18, 2020
Sponsor
State University of New York at Buffalo
search

1. Study Identification

Unique Protocol Identification Number
NCT03751813
Brief Title
Baby Bump Lifestyle Intervention Supplement Study
Acronym
Baby BLISS
Official Title
Baby Bump Lifestyle Intervention Supplement Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
IRB had concerns about study; terminated
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo supplement
Arm Title
Supplement
Arm Type
Experimental
Arm Description
actual supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplement
Intervention Description
Supplement will be given to this group to take daily for 8 weeks
Primary Outcome Measure Information:
Title
lower blood stress markers via venous draw
Description
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.
Time Frame
9 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
SUNY Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Baby Bump Lifestyle Intervention Supplement Study

We'll reach out to this number within 24 hrs