Pregnancy RelatedPREDIPNCT04430439

Emotion-Diet Interactions in Pregnancy

A study testing Psychosocial stress in people with Pregnancy Related and Stress, Psychological, run by University of California, Irvine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will investigate how maternal emotional state following a controlled stress exposure in pregnancy influences blood glucose and insulin levels after eating a standardized meal, and whether the effects of emotional state on blood glucose and insulin is different after eating a healthy meal (low GI) compared… 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?: Psychosocial stress
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 2 sitesUnited States
Study dates: 11 May 2021to 28 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

English and/or Spanish speaking
18-22 week's gestation
Pre-pregnancy BMI 25.0-39.9 kg/m2
Singleton, intrauterine pregnancy
Non-smoker
Non-diabetic and normal result on a random peripheral blood glucose test at the screening visit (<200 mg/dl)

Who cannot join

Non-fluency in English or Spanish
BMI <25.0 or ≥40.0 kg/m2
>22 week's gestation
multiple pregnancy
current smoker
present/prior obstetric conditions (preeclampsia, infections, placental abnormalities, uterine anomalies, congenital malformations, fetal chromosomal abnormalities)

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presence of any conditions that may dysregulate neuroendocrine, metabolic or cardiovascular function, such as diabetes, hepatic, renal, or autoimmune disorders
current psychiatric disorders or undergoing treatment/taking psychiatric medications
use of systemic/frequent corticosteroids or thyroid, lipid-lowering or anti-diabetic medications
gestational diabetes mellitus or raised glucose result detected on the screening visit
unwilling to eat the standard breakfast meal at each laboratory visit

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of California, Irvine
Irvine, California, 92617
UCI Medical Center, University of California, Irvine
Orange, California, 92868

Other trials in United States

About this study

Official title: Postprandial Response to Emotion-Diet Interactions in Pregnancy

Read the detailed description

Maternal glucose-insulin homeostasis in pregnancy represents one of the most important physiological processes for maternal and child health outcomes. Although maternal diet is a key regulator of this process, its effects vary widely across individuals. Maternal stress could represent a moderator of considerable importance in this regard, yet little is known about the effects of stress on glycemic control in pregnancy and whether the effects of stress may vary as a function of diet quality. This project will investigate the effects of acute psychosocial stress exposure on the postprandial metabolic response to a meal of varying glycemic index (GI) among women with overweight/obesity in mid-pregnancy.

Conditions: Pregnancy Related, Stress, Psychological, Glucose Intolerance During Pregnancy, Emotional Stress, Postprandial Hyperglycemia, Insulin Sensitivity/Resistance
Being tested: Psychosocial stress, Control non-stress
Medical subject headings: Stress, Psychological, Hyperglycemia, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psychosocial stressBehavioural
The TSST is a 15 minute standardized lab-based challenge task that involves speech preparation, speech delivery while being evaluated by strangers and video taped, and complex mental arithmetic with critiques if errors are made.
Control non-stressBehavioural
Participants will have a relaxed 15 minute conversation with a familiar research team member.

Study groups in NCT04430439
Study group	Role	What they receive
Psychosocial stress	Experimental	Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI). Receives: Behavioral: Psychosocial stress
Control non-stress	Active comparator	Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI). Receives: Behavioral: Control non-stress

What is being measured

The primary outcome is the main question the study is designed to answer.

Postprandial Glycemic Response With Stress Exposure
Glycemic response (area-under-the-curve of glucose) to the assigned meal type during the visit with the psychosocial stress task (TSST)
Measured: 2 weeks
Postprandial Glycemic Response Without Stress Exposure
Glycemic response (glucose area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition
Measured: 2 weeks

Secondary outcomes (2)

Postprandial Insulin Response With Stress Exposure
Insulin response (area-under-the-curve) to the assigned meal type during the visit with the standardized stress task
Measured: 2 weeks
Postprandial Insulin Response Without Stress Exposure
Insulin response (area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202128 Feb 2024

First posted12 Jun 2020
Study start11 May 2021
Primary completion14 Feb 2024
Study completion28 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
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: Randomised
Intervention model: Crossover
Model description: Participants will be first randomized in a parallel design to meal type (low vs high GI). Within the meal arms, participants will be randomized in a cross-over design to undergo the lab-based stress and non-stress tasks.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04430439
Sponsor's protocol ID: 20205914
Other IDs: R00HD096109
Acronym: PREDIP
Status last verified: Aug 2025
First submitted: 10 Jun 2020
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postprandial Response to Emotion-Diet Interactions in Pregnancy
ClinicalTrials.gov ID: NCT04430439
Acronym / sponsor ID: PREDIP / 20205914
Conditions: Pregnancy Related, Stress, Psychological, Glucose Intolerance During Pregnancy, Emotional Stress, Postprandial Hyperglycemia, Insulin Sensitivity/Resistance
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: University of California, IrvineUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 11 May 2021 (actual)
Primary completion: 14 Feb 2024 (actual)
Study completion: 28 Feb 2024 (actual)
First posted: 12 Jun 2020 (actual)
Results: Posted 22 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Participants will be first randomized in a parallel design to meal type (low vs high GI). Within the meal arms, participants will be randomized in a cross-over design to undergo the lab-based stress and non-stress tasks.

Arm	Type	Receives
Psychosocial stress	Experimental	Behavioral: Psychosocial stressParticipants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).
Control non-stress	Active comparator	Behavioral: Control non-stressParticipants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

English and/or Spanish speaking
18-22 week's gestation
Pre-pregnancy BMI 25.0-39.9 kg/m2
Singleton, intrauterine pregnancy
Non-smoker

Key exclusion criteria (11 listed)

Non-fluency in English or Spanish
BMI <25.0 or ≥40.0 kg/m2
>22 week's gestation
multiple pregnancy
current smoker

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
Psychosocial stressThe TSST is a 15 minute standardized lab-based challenge task that involves speech preparation, speech delivery while being evaluated by strangers and video taped, and complex mental arithmetic with critiques if errors are made.	Behavioural	Psychosocial stress
Control non-stressParticipants will have a relaxed 15 minute conversation with a familiar research team member.	Behavioural	Control non-stress

Primary outcome

Postprandial Glycemic Response With Stress Exposure
Time frame: 2 weeks
Glycemic response (area-under-the-curve of glucose) to the assigned meal type during the visit with the psychosocial stress task (TSST)
Postprandial Glycemic Response Without Stress Exposure
Time frame: 2 weeks
Glycemic response (glucose area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition

2 secondary outcomes

Postprandial Insulin Response With Stress Exposure
Time frame: 2 weeks
Postprandial Insulin Response Without Stress Exposure
Time frame: 2 weeks

Results and safety

Results posted to the registry on 22 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low GI Meal - Stress, Then No Stress	30	26
Low GI Meal - No Stress, Then Stress	27	22
High GI Meal - Stress, Then No Stress	22	20
High GI Meal - No Stress, Then Stress	34	28

Primary outcome: Postprandial Glycemic Response With Stress Exposure

Time frame: 2 weeks. Mean (Standard Deviation). Unit: mg/dl * minutes

Measure	Low GI Meal n = 37	High GI Meal n = 38
Value	12998.83 (3507.22)	12833.69 (4643.66)

Population analysed: 15 participants only completed the first lab visit and missed the second visit. Of those, 11 were assigned to undergo the stress task at visit 2 and thus are missing data for the present outcome. Among those who did complete the visit with the stress task, some participants had insufficient blood sample collections at fasting or later timepoints, such that glucose values were missing and glucose AUC could not be computed.

Primary outcome: Postprandial Glycemic Response Without Stress Exposure

Time frame: 2 weeks. Mean (Standard Deviation). Unit: mg/dl * minutes

Measure	Low GI Meal n = 38	High GI Meal n = 45
Value	12754.18 (3028.18)	13099.27 (4038.88)

Population analysed: 15 participants only completed lab visit 1 and missed lab visit 2. Of those, 3 were assigned to undergo the non-stress task on visit 2 and thus are missing data for this analysis. Some participants had insufficient blood sample collections at fasting or later timepoints, such that glucose values were missing and glucose AUC could not be computed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, up to 8 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Psychosocial Stress	0 of 113 (0%)	0 of 113 (0%)	0 of 113

Limitations and caveats (from the sponsor): Could not obtain an assay to test free fatty acids from plasma samples so we were unable to fulfill the aim of assessing the impact of stress exposure on postprandial fatty acid response to the meals.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Psychosocial stress in people with Pregnancy Related and Stress, Psychological, run by University of California, Irvine at 2 sites 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 6 inclusion and 11 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Postprandial Glycemic Response With Stress Exposure (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT04430439.

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 22 Aug 2025.