Gestational DiabetesBaby BLISSNCT03751813
Baby Bump Lifestyle Intervention Supplement Study
A study testing Supplement in people with Gestational Diabetes, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.
- Conditions
- Gestational Diabetes
- Being tested
- Supplement
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
Supplement will be given to this group to take daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo supplement Receives: Dietary Supplement: Supplement |
| Supplement | Experimental | actual supplement Receives: Dietary Supplement: Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start21 Mar 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Why it stopped: IRB had concerns about study; terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Ling Kong, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751813
- Sponsor's protocol ID
- Baby BLISS
- Acronym
- Baby BLISS
- Status last verified
- Feb 2020
- First submitted
- 19 Nov 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby Bump Lifestyle Intervention Supplement Study
- ClinicalTrials.gov ID
- NCT03751813
- Acronym / sponsor ID
- Baby BLISS / Baby BLISS
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB had concerns about study; terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Supplementplacebo supplement |
| Supplement | Experimental | Dietary Supplement: Supplementactual supplement |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementSupplement will be given to this group to take daily for 8 weeks | Dietary supplement | Placebo, Supplement |
Primary outcome
lower blood stress markers via venous draw
Time frame: 9 months
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.
Results and safety
The study was stopped early (reason given: IRB had concerns about study; terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Gestational Diabetes, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IRB had concerns about study; terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower blood stress markers via venous draw (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020; AzTrials last refreshed its copy on 2 Nov 2026.