Baby Bump Lifestyle Intervention Supplement Study | NCT03751813

Studies
Baby Bump Lifestyle Intervention Supplement Study

NCT03751813

Sponsor

State University of New York at Buffalo

Status

Terminated

Last Update Posted

Feb 20, 2020Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Gestational Diabetes

Interventions

Supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IRB had concerns about study; terminated

Expanded Access Info

Start Date

Mar 21, 2019Actual

Primary Completion Date

Nov 30, 2019Actual

Completion Date

Nov 30, 2019Actual

First Submitted Date

Nov 19, 2018

First Submission Date that Met QC Criteria

Nov 21, 2018

First Posted Date

Nov 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2020

Last Update Posted Date

Feb 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kai Ling Kong, Principal Investigator, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	placebo supplement	Dietary Supplement: Supplement
Supplement	Experimental	actual supplement	Dietary Supplement: Supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supplement	Dietary Supplement	Supplement will be given to this group to take daily for 8 weeks	Placebo Supplement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Buffalo		Buffalo	New York	14214	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided