Pregnancy RelatedPEDIMetNCT03278392
Maternal Emotions and Diet in Pregnancy
A study testing Trier Social Stress Test in people with Pregnancy Related and Stress, Psychological, run by University of California, Irvine at 1 site in United States.
Trial summary
This study seeks to understand how a mother's emotional state in pregnancy influences her biological response to food intake. 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
- Pregnancy Related, Stress, Psychological, Glucose Intolerance During Pregnancy
- What is being tested?
- Trier Social Stress Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 10 May 2021
- 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
- Age 18-40 years
- Hispanic ethnicity
- English and/or Spanish speaking
- Multiparous
- 28-30 week's gestation
- Pre-pregnancy BMI 25.0-34.9 kg/m2
Show all 9Show fewer
- Singleton, intrauterine pregnancy
- Non-smoker
- Non-diabetic and negative result on routine prenatal glucose challenge test (GCT)
Who cannot join
- BMI <25.0 or ≥35.0 kg/m2
- >30 week's gestation
- multiple pregnancy
- nulliparous
- present/prior obstetric risk conditions (hypertension, preeclampsia, infections, placental abnormalities)
- current smoker
Show all 9Show fewer
- current psychiatric disorders or undergoing treatment/taking psychiatric medications
- Use of systemic/frequent corticosteroids or thyroid meds
- Diabetic or presence of other metabolic or neuroendocrine disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI Medical Center, University of California, Irvine
Orange, California, 92868
About this study
Official title: Prenatal Emotion-Diet Interactions and the Metabolic Response
This study seeks to understand how a mother's emotional state in pregnancy influences her biological response to food intake.
Read the detailed description
The purpose of this research study is to understand how a mother's emotional state in pregnancy influences her biological response to food intake. Natural variation in emotional and mental state is frequently experienced in daily life, including during pregnancy. While the investigators understand that a healthy diet is important in pregnancy for maintaining blood sugar levels and other metabolic factors within normal ranges for optimal development of the baby, less consideration is given to the health effects of a mother's mental state during pregnancy. It may even be possible that, regardless of what a woman eats or drinks, the way her body responds to food may differ according to her emotional or mental state.
This research is particularly interested in understanding how the combination of maternal emotional state and diet influence metabolism in pregnancy. Thus, the aim of this study is to test whether and how an individual's emotional response to a mental challenge of varying complexity during pregnancy modifies the body's metabolic response to a standard breakfast.
- Being tested
- Trier Social Stress Test, Placebo Non-stress task
- Keywords
- pregnancy, metabolism, stress, emotional state, diet, glycemic response
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TestBehavioural
Task instructions provided to subject (5mins), subject prepares speech on their strengths and weaknesses (5 mins), subject delivers speech before a stern evaluative committee while being video-taped (5 mins), subject completes a mental arithmetic challenge task before the evaluative committee with critiques if errors are made (5mins).
Placebo Non-stress taskBehavioural
Subject engages in a friendly conversation about a neutral or happy topic (e.g. recent holiday, favorite past-times) for 15 minutes with a familiar research staff member.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial challenge task | Experimental | Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink Receives: Behavioral: Trier Social Stress Test |
| Placebo challenge task | Sham comparator | Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink Receives: Behavioral: Placebo Non-stress task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the glycemic response to the standardized meal +/- psychosocial challenge task
Glycemic response (area-under-the-curve of glucose) to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.
Measured: 2 hours
Secondary outcomes (2)
Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task
Area under the curve of blood triglycerides to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.
Measured: 2 hours
Physiological stress response to the psychosocial challenge task
Area under the curve of salivary cortisol following exposure to the psychosocial challenge task
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start17 Nov 2017
- Primary completion1 May 2020
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Lindsay, University of California, Irvine
- Investigators
- Karen L Lindsay, Principal investigator, UC Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278392
- Sponsor's protocol ID
- UCI 2017-3803
- Acronym
- PEDIMet
- Status last verified
- May 2021
- First submitted
- 6 Sep 2017
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lindsay KL, Buss C, Wadhwa PD, Entringer S. The Interplay between Maternal Nutrition and Stress during Pregnancy: Issues and Considerations. Ann Nutr Metab. 2017;70(3):191-200. doi: 10.1159/000457136. Epub 2017 Mar 17.
PubMed 28301838
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Emotion-Diet Interactions and the Metabolic Response
- ClinicalTrials.gov ID
- NCT03278392
- Acronym / sponsor ID
- PEDIMet / UCI 2017-3803
- Keywords
- pregnancy, metabolism, stress, emotional state, diet, glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Davis
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 11 Sep 2017 (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.
This study seeks to understand how a mother's emotional state in pregnancy influences her biological response to food intake.
Detailed description
The purpose of this research study is to understand how a mother's emotional state in pregnancy influences her biological response to food intake. Natural variation in emotional and mental state is frequently experienced in daily life, including during pregnancy. While the investigators understand that a healthy diet is important in pregnancy for maintaining blood sugar levels and other metabolic factors within normal ranges for optimal development of the baby, less consideration is given to the health effects of a mother's mental state during pregnancy. It may even be possible that, regardless of what a woman eats or drinks, the way her body responds to food may differ according to her emotional or mental state.
This research is particularly interested in understanding how the combination of maternal emotional state and diet influence metabolism in pregnancy. Thus, the aim of this study is to test whether and how an individual's emotional response to a mental challenge of varying complexity during pregnancy modifies the body's metabolic response to a standard breakfast.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial challenge task | Experimental | Behavioral: Trier Social Stress TestParticipants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink |
| Placebo challenge task | Sham comparator | Behavioral: Placebo Non-stress taskParticipants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-40 years
- Hispanic ethnicity
- English and/or Spanish speaking
- Multiparous
- 28-30 week's gestation
Key exclusion criteria (9 listed)
- BMI <25.0 or ≥35.0 kg/m2
- >30 week's gestation
- multiple pregnancy
- nulliparous
- present/prior obstetric risk conditions (hypertension, preeclampsia, infections, placental abnormalities)
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 |
|---|---|---|
| Trier Social Stress TestTask instructions provided to subject (5mins), subject prepares speech on their strengths and weaknesses (5 mins), subject delivers speech before a stern evaluative committee while being video-taped (5 mins), subject completes a mental arithmetic challenge task before the evaluative committee with critiques if errors are made (5mins). | Behavioural | Psychosocial challenge task |
| Placebo Non-stress taskSubject engages in a friendly conversation about a neutral or happy topic (e.g. recent holiday, favorite past-times) for 15 minutes with a familiar research staff member. | Behavioural | Placebo challenge task |
Primary outcome
Difference in the glycemic response to the standardized meal +/- psychosocial challenge task
Time frame: 2 hours
Glycemic response (area-under-the-curve of glucose) to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.
2 secondary outcomes
Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task
Time frame: 2 hours
Physiological stress response to the psychosocial challenge task
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Background: PubMed 28301838Lindsay KL, Buss C, Wadhwa PD, Entringer S. The Interplay between Maternal Nutrition and Stress during Pregnancy: Issues and Considerations. Ann Nutr Metab. 2017;70(3):191-200. doi: 10.1159/000457136. Epub 2017 Mar 17.
- 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.
Karen L Lindsay principal investigator
UC Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier Social Stress Test in people with Pregnancy Related and Stress, Psychological, run by University of California, Irvine 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 13 May 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in the glycemic response to the standardized meal +/- psychosocial challenge task (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278392, which also lists 1 linked publication.
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 13 May 2021.