Clinical trial NCT05890014: Effects of Diet on Perinatal Mood and Cognition
Official title: Effects of Diet on Perinatal Mood and Cognition
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mood
Mothers
Healthy
Keywords: Cognition
Mood
Flavonoids
Diet
Postpartum
Blood pressure
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The baby blues are a significant event which can occur immediately following childbirth and is a normal experience occurring in up to 76% of new mothers, characterised by mood swings, irritability and sadness typically lasting 10-14 days. Research suggests that the more severe and longer duration of the baby blues, the higher risk of later postnatal mood disorders. Therefore, this represents a critical period which could benefit from an intervention which may prevent symptom onset or an increase in the severity of mood disorders later in the postpartum.

Evidence suggests that consumption of flavonoid rich foods can improve physical health, mood and cognition. Prior research investigating flavonoid intervention in mothers in the first 6 months and 1 year postpartum found significant benefits to mood in the new mothers after daily flavonoid supplementation, showing promise for the management of mood in a key period for mothers, where risk of Postnatal Depression (PND) is high. The immediate postpartum also represents a period of cognitive changes reported to affect up to 80% of new mothers. In addition, women during this time are at an increased risk of high blood pressure and hypertension, which is thought to be a risk factor for the onset and severity of depressive symptoms and cognitive decrements. Flavonoids have been reported to improve cognition and cardiovascular health, therefore, introducing a flavonoid intervention could have benefits to cognition and blood pressure in new mothers.

The aim of the current study will be to explore whether the implementation of a high flavonoid diet across a 30-day period will positively affect maternal mental health, cognition and blood pressure. Participants will be assigned to one of three groups; high or low flavonoid diet or a control condition for 30-days, starting at days 0-4 after birth. They will have visits from the researcher at 6 separate time points between the third trimester and 12 weeks postpartum. At each visit, participants will be asked to complete mood questionnaires (PANAS-NOW), Edinburgh Postnatal Depression Scale (EPDS), Postpartum Specific Anxiety Scale (PSAS), State-Trait Anxiety Inventory (STAI), Edinburgh Postnatal Depression Scale- Partner (EPDS-P) followed by a cognitive battery (MANT, RAVLT, PRMQ) and blood pressure recordings (systolic and diastolic blood pressure). Between visits, participants will be contacted by the researcher to record retrospective 24hr food recalls (Intake24).

Detailed description: The study will employ a between-groups, randomised, controlled, participant-blind design with three groups and six time points. Participants will be allocated to one of three groups; a high flavonoid condition (consumption of 2 portions of flavonoid rich food per day), low flavonoid condition (consumption of one portion of flavonoid rich food per day) and a control (no change to diet). Participants will be quasi-randomised to condition based on their baseline flavonoid intake, taken at Timepoint 1 using the European Prospective Investigation of Cancer (EPIC)-Norfolk Food Frequency Questionnaire to ensure there is an even spread of baseline flavonoid consumption in participants across all conditions. At this timepoint, participants will additionally complete the Immediate Mood Scaler. Participants will be recruited at any stage of their pregnancy though testing will not take place until their third trimester (weeks 27+). Participants will be invited to a study investigating diet mood and cognition. The study will take place in person, at participant homes over 6 time points; 1) a screening session, 2) time 1 (third trimester), 3) time 2 (after birth 0-4 days, pre intervention), 4) time 3 (mid-way through intervention \~15 days), 5) time 4 (post-intervention \~30 days) and 6) time 5 (follow up, 12 weeks postpartum).

Interested participants will be invited to an in-person screening session. Once participants have consented to taking part, they will be asked to provide some demographic information (e.g. age, occupation, health or psychological diagnosis). Participants will then complete practice versions of the cognitive tests. At each timepoint, the experimenter will visit participants to complete outcome measures (PANAS-NOW, EPDS, PSAS, STAI, EPDS-P, MANT, Spatial n-back, RAVLT and PRMQ, Systolic and Diastolic blood pressure). Over the course of the study, participants will be contacted at nine random timepoints to complete retrospective 24hr food recalls using the software Intake24.

Participants in the flavonoid intervention groups will be contacted by the researcher shortly before time 2 where they will be sent a list of the intervention foods and asked to choose a food item which the researcher will bring to the testing session. This is to ensure that participants can start the intervention after the testing session at time 2 without needing to visit a supermarket during this sensitive time. During this session, participants will also be asked some questions about the baby and birth experience (e.g. how old their infant is, infants sex, mode of delivery, birth complications). After the outcome measures have been taken, participants will be informed of their condition and instructed to begin the intervention. The two intervention groups will also be asked to keep a food log of their selected intervention foods for the 30-day period.

At the final timepoint, upon completion of outcome measures, participants will receive the debrief document and they will receive information about payment and dietary assessment via email. Participants will also be reminded of their right to withdraw their data from the study if they wish. Helplines and support web links will be provided to all participants as well as encouragement for participants to contact their General Practitioner should they wish to seek support. Helplines and weblinks include Samaritans United Kingdom and PANDAS Foundation. Weblinks to National Health Service (NHS), MIND mental health charity and the Association for Postnatal Illness.

Eligibility criteria: Inclusion Criteria:

* Participants must be pregnant (reliant on mothers' self-reporting)

Exclusion Criteria:

* Participants beyond 38 weeks of their pregnancy (reliant on mothers' self reporting)

Primary outcomes:
measure: Mean depressive symptoms
timeFrame: Days 0-4 postpartum
measure: Mean depressive symptoms
timeFrame: 2 weeks postpartum
measure: Mean depressive symptoms
timeFrame: 4 weeks postpartum
measure: Mean depressive symptoms
timeFrame: 12 weeks postpartum
measure: Mean state anxiety
timeFrame: Days 0-4 postpartum
measure: Mean state anxiety
timeFrame: 2 weeks postpartum
measure: Mean state anxiety
timeFrame: 4 weeks postpartum
measure: Mean state anxiety
timeFrame: 12 weeks postpartum
Secondary outcomes:
measure: Mean postpartum-specific anxiety symptoms
timeFrame: Days 0-4 postpartum
measure: Mean postpartum-specific anxiety symptoms
timeFrame: 2 weeks postpartum
measure: Mean postpartum-specific anxiety symptoms
timeFrame: 4 weeks postpartum
measure: Mean postpartum-specific anxiety symptoms
timeFrame: 12 weeks postpartum
measure: Mean current affect
timeFrame: Days 0-4 postpartum
measure: Mean current affect
timeFrame: 2 weeks postpartum
measure: Mean current affect
timeFrame: 4 weeks postpartum
measure: Mean current affect
timeFrame: 12 weeks postpartum
measure: Mean partner depressive symptoms
timeFrame: 0-4 postpartum
measure: Mean partner depressive symptoms
timeFrame: 2 weeks postpartum
measure: Mean partner depressive symptoms
timeFrame: 4 weeks postpartum
measure: Mean partner depressive symptoms
timeFrame: 12 weeks postpartum
measure: Mean subjective memory scores
timeFrame: Days 0-4 postpartum
measure: Mean subjective memory scores
timeFrame: 2 weeks postpartum
measure: Mean subjective memory scores
timeFrame: 4 weeks postpartum
measure: Mean subjective memory scores
timeFrame: 12 weeks postpartum
measure: Mean subjective mood scores
timeFrame: Baseline only
measure: Subjective sleep scores
timeFrame: Days 0-4 postpartum
measure: Subjective sleep scores
timeFrame: 2 weeks postpartum
measure: Subjective sleep scores
timeFrame: 4 weeks postpartum
measure: Subjective sleep scores
timeFrame: 12 weeks postpartum
measure: Blood pressure
timeFrame: Days 0-4 postpartum
measure: Blood pressure
timeFrame: 2 weeks postpartum
measure: Blood pressure
timeFrame: 4 weeks postpartum
measure: Blood pressure
timeFrame: 12 weeks postpartum
measure: Verbal memory
timeFrame: Days 0-4 postpartum
measure: Verbal memory
timeFrame: 2 weeks postpartum
measure: Verbal memory
timeFrame: 4 weeks postpartum
measure: Verbal memory
timeFrame: 12 weeks postpartum
measure: Sustained attention and executive functioning
timeFrame: Days 0-4 postpartum
measure: Sustained attention and executive functioning
timeFrame: 2 weeks postpartum
measure: Sustained attention and executive functioning
timeFrame: 4 weeks postpartum
measure: Sustained attention and executive functioning
timeFrame: 12 weeks postpartum
measure: Visuospatial working memory
timeFrame: Days 0-4 postpartum
measure: Visuospatial working memory
timeFrame: 2 weeks postpartum
measure: Visuospatial working memory
timeFrame: 4 weeks postpartum
measure: Visuospatial working memory
timeFrame: 12 weeks postpartum
Other outcomes:
measure: General diet
timeFrame: Baseline only
measure: 24-hr dietary recall
timeFrame: Pregnancy (up to 10 weeks before birth date)
measure: 24-hr dietary recall
timeFrame: Postpartum during intervention (up to 34 days after birth)
measure: 24-hr dietary recall
timeFrame: Postpartum after intervention (up to 12 weeks after birth)
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Daniel Lamport, PhD
role: PRINCIPAL_INVESTIGATOR
References: