MoodNCT05890014
Effects of Diet on Perinatal Mood and Cognition
A study testing Flavonoid-rich diet in people with Mood and Mothers, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Flavonoid-rich diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2023to Dec 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be pregnant (reliant on mothers' self-reporting)
Who cannot join
- Participants beyond 38 weeks of their pregnancy (reliant on mothers' self reporting)
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- Flavonoid-rich diet
- Keywords
- Cognition, Mood, Flavonoids, Diet, Postpartum, Blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavonoid-rich dietDietary supplement
Inclusion of foods rich in flavonoids.
| Study group | Role | What they receive |
|---|---|---|
| High flavonoid group | Experimental | Participants will be encouraged to consume 2 x flavonoid-rich food items per day from the following list of flavonoid-rich foods across 30-days, above what they already consume each day, typically.
Orange juice (190 mls) Grapefruit juice (169mls) Dark chocolate (64g) Spinach (109g) Blueberry (64g) Strawberry (157g) Blackberry (81g) Blackcurrant (61g) Cherries (182g) Plums (90g) Black grapes (142g) Oranges (247g) Black olives (89g) Red grapes (339g) Receives: Dietary Supplement: Flavonoid-rich diet |
| Low flavonoid group | Experimental | Participants will be encouraged to consume 1 x flavonoid-rich food items per day from the following list of flavonoid-rich foods across 30-days, above what they already consume each day, typically.
Orange juice (190 mls) Grapefruit juice (169mls) Dark chocolate (64g) Spinach (109g) Blueberry (64g) Strawberry (157g) Blackberry (81g) Blackcurrant (61g) Cherries (182g) Plums (90g) Black grapes (142g) Oranges (247g) Black olives (89g) Red grapes (339g) Receives: Dietary Supplement: Flavonoid-rich diet |
| Control | No intervention | Participants will be given no instructions regarding adding food items to their diet. They will be encouraged to continue their diet as normal for 30-days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean depressive symptoms
Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.
Measured: Days 0-4 postpartum
Mean depressive symptoms
Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.
Measured: 2 weeks postpartum
Mean depressive symptoms
Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.
Measured: 4 weeks postpartum
Mean depressive symptoms
Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.
Measured: 12 weeks postpartum
Mean state anxiety
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.
Measured: Days 0-4 postpartum
Mean state anxiety
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.
Measured: 2 weeks postpartum
Mean state anxiety
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.
Measured: 4 weeks postpartum
Mean state anxiety
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.
Measured: 12 weeks postpartum
Secondary outcomes (37)
Mean postpartum-specific anxiety symptoms
Assessed using scores from the Postpartum-Specific Anxiety Scale. This is a 51-item questionnaire that examines the frequency of maternal and infant focused anxieties experienced by women over the last week. It can be used at any time during the first year following birth and is found to be a valid and reliable measure. Each response is given a score of between 1 and 4 with the maximum score being a total of 204, with higher scores indicating higher levels of anxiety where a score of 112 or above indicating likelihood the individual suffering from an anxiety disorder.
Measured: Days 0-4 postpartum
Mean postpartum-specific anxiety symptoms
Assessed using scores from the Postpartum-Specific Anxiety Scale. This is a 51-item questionnaire that examines the frequency of maternal and infant focused anxieties experienced by women over the last week. It can be used at any time during the first year following birth and is found to be a valid and reliable measure. Each response is given a score of between 1 and 4 with the maximum score being a total of 204, with higher scores indicating higher levels of anxiety where a score of 112 or above indicating likelihood the individual suffering from an anxiety disorder.
Measured: 2 weeks postpartum
Mean postpartum-specific anxiety symptoms
Assessed using scores from the Postpartum-Specific Anxiety Scale. This is a 51-item questionnaire that examines the frequency of maternal and infant focused anxieties experienced by women over the last week. It can be used at any time during the first year following birth and is found to be a valid and reliable measure. Each response is given a score of between 1 and 4 with the maximum score being a total of 204, with higher scores indicating higher levels of anxiety where a score of 112 or above indicating likelihood the individual suffering from an anxiety disorder.
Measured: 4 weeks postpartum
Mean postpartum-specific anxiety symptoms
Assessed using scores from the Postpartum-Specific Anxiety Scale. This is a 51-item questionnaire that examines the frequency of maternal and infant focused anxieties experienced by women over the last week. It can be used at any time during the first year following birth and is found to be a valid and reliable measure. Each response is given a score of between 1 and 4 with the maximum score being a total of 204, with higher scores indicating higher levels of anxiety where a score of 112 or above indicating likelihood the individual suffering from an anxiety disorder.
Measured: 12 weeks postpartum
Mean current affect
Assessed using scores from the Positive and Negative Affect Scale. This questionnaire has 20 items that describe some feelings and emotions. The participant needs to mark how much they are experiencing these feelings on a scale from 1-5. This produces scores of Positive Affect and Negative Affect; higher scores reflect higher positive or negative mood, respectively.
Measured: Days 0-4 postpartum
Mean current affect
Assessed using scores from the Positive and Negative Affect Scale. This questionnaire has 20 items that describe some feelings and emotions. The participant needs to mark how much they are experiencing these feelings on a scale from 1-5. This produces scores of Positive Affect and Negative Affect; higher scores reflect higher positive or negative mood, respectively.
Measured: 2 weeks postpartum
Mean current affect
Assessed using scores from the Positive and Negative Affect Scale. This questionnaire has 20 items that describe some feelings and emotions. The participant needs to mark how much they are experiencing these feelings on a scale from 1-5. This produces scores of Positive Affect and Negative Affect; higher scores reflect higher positive or negative mood, respectively.
Measured: 4 weeks postpartum
Mean current affect
Assessed using scores from the Positive and Negative Affect Scale. This questionnaire has 20 items that describe some feelings and emotions. The participant needs to mark how much they are experiencing these feelings on a scale from 1-5. This produces scores of Positive Affect and Negative Affect; higher scores reflect higher positive or negative mood, respectively.
Measured: 12 weeks postpartum
Mean partner depressive symptoms
Using the EPDS-P. This is a 10-item measure adapted from the EPDS. The EPDS-P is a revision of the EPDS to provide a proxy of the partners symptoms of depression, in this study, the mothers will complete the EPDS-P to provide information about paternal depressive symptoms. The scale and scoring of the EPDS-P is the same as the EPDS, though there is no cut-off in the EPDS-P to indicate likelihood for depressive disorder.
Measured: 0-4 postpartum
Mean partner depressive symptoms
Using the EPDS-P. This is a 10-item measure adapted from the EPDS. The EPDS-P is a revision of the EPDS to provide a proxy of the partners symptoms of depression, in this study, the mothers will complete the EPDS-P to provide information about paternal depressive symptoms. The scale and scoring of the EPDS-P is the same as the EPDS, though there is no cut-off in the EPDS-P to indicate likelihood for depressive disorder.
Measured: 2 weeks postpartum
Mean partner depressive symptoms
Using the EPDS-P. This is a 10-item measure adapted from the EPDS. The EPDS-P is a revision of the EPDS to provide a proxy of the partners symptoms of depression, in this study, the mothers will complete the EPDS-P to provide information about paternal depressive symptoms. The scale and scoring of the EPDS-P is the same as the EPDS, though there is no cut-off in the EPDS-P to indicate likelihood for depressive disorder.
Measured: 4 weeks postpartum
Mean partner depressive symptoms
Using the EPDS-P. This is a 10-item measure adapted from the EPDS. The EPDS-P is a revision of the EPDS to provide a proxy of the partners symptoms of depression, in this study, the mothers will complete the EPDS-P to provide information about paternal depressive symptoms. The scale and scoring of the EPDS-P is the same as the EPDS, though there is no cut-off in the EPDS-P to indicate likelihood for depressive disorder.
Measured: 12 weeks postpartum
Mean subjective memory scores
Prospective and retrospective memory questionnaire. The PRMQ is a 16-item rating scale, designed to assess the frequency of different types of memory failures whereby higher scores indicate greater frequency of memory failures. Participants are asked to score questions of a 5-point scale 1 (never), 2 (rarely), 3 (sometimes), 4 (quite often), 5 (very often). Results can be derived for prospective or retrospective, short-term or long-term, self-cued or environmentally cued.
Measured: Days 0-4 postpartum
Mean subjective memory scores
Prospective and retrospective memory questionnaire. The PRMQ is a 16-item rating scale, designed to assess the frequency of different types of memory failures whereby higher scores indicate greater frequency of memory failures. Participants are asked to score questions of a 5-point scale 1 (never), 2 (rarely), 3 (sometimes), 4 (quite often), 5 (very often). Results can be derived for prospective or retrospective, short-term or long-term, self-cued or environmentally cued.
Measured: 2 weeks postpartum
Mean subjective memory scores
Prospective and retrospective memory questionnaire. The PRMQ is a 16-item rating scale, designed to assess the frequency of different types of memory failures whereby higher scores indicate greater frequency of memory failures. Participants are asked to score questions of a 5-point scale 1 (never), 2 (rarely), 3 (sometimes), 4 (quite often), 5 (very often). Results can be derived for prospective or retrospective, short-term or long-term, self-cued or environmentally cued.
Measured: 4 weeks postpartum
Mean subjective memory scores
Prospective and retrospective memory questionnaire. The PRMQ is a 16-item rating scale, designed to assess the frequency of different types of memory failures whereby higher scores indicate greater frequency of memory failures. Participants are asked to score questions of a 5-point scale 1 (never), 2 (rarely), 3 (sometimes), 4 (quite often), 5 (very often). Results can be derived for prospective or retrospective, short-term or long-term, self-cued or environmentally cued.
Measured: 12 weeks postpartum
Mean subjective mood scores
Immediate mood scale-This questionnaire contains 22 items developed to assess dynamic components of mood. Participants are asked to rate their current mood state on a continuum using 7-point Likert scales (e.g., happy-sad, distracted-focused, sleepy-alert). For each item, an integer score between 1 and 7 is derived. The total score for this scale is the sum of the scores on all 22 items.
Measured: Baseline only
Subjective sleep scores
Using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated measure of sleep assessing qualities and patterns within the last month of sleep habits in adults. Seven components of sleep (quality, latency, duration, efficiency, disturbance, use of sleep medication, daytime dysfunction) will be summed to achieve a global PSQI score ranging from 0 to 21 points, where scores above 5 indicates sleep problems.
Measured: Days 0-4 postpartum
Subjective sleep scores
Using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated measure of sleep assessing qualities and patterns within the last month of sleep habits in adults. Seven components of sleep (quality, latency, duration, efficiency, disturbance, use of sleep medication, daytime dysfunction) will be summed to achieve a global PSQI score ranging from 0 to 21 points, where scores above 5 indicates sleep problems.
Measured: 2 weeks postpartum
Subjective sleep scores
Using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated measure of sleep assessing qualities and patterns within the last month of sleep habits in adults. Seven components of sleep (quality, latency, duration, efficiency, disturbance, use of sleep medication, daytime dysfunction) will be summed to achieve a global PSQI score ranging from 0 to 21 points, where scores above 5 indicates sleep problems.
Measured: 4 weeks postpartum
Subjective sleep scores
Using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated measure of sleep assessing qualities and patterns within the last month of sleep habits in adults. Seven components of sleep (quality, latency, duration, efficiency, disturbance, use of sleep medication, daytime dysfunction) will be summed to achieve a global PSQI score ranging from 0 to 21 points, where scores above 5 indicates sleep problems.
Measured: 12 weeks postpartum
Blood pressure
Resting systolic and diastolic blood pressure will be taken with an ambulatory blood pressure monitor. Measurements will be taken on participants left arm and the mean of three consecutive measurements will be calculated.
Measured: Days 0-4 postpartum
Blood pressure
Resting systolic and diastolic blood pressure will be taken with an ambulatory blood pressure monitor. Measurements will be taken on participants left arm and the mean of three consecutive measurements will be calculated.
Measured: 2 weeks postpartum
Blood pressure
Resting systolic and diastolic blood pressure will be taken with an ambulatory blood pressure monitor. Measurements will be taken on participants left arm and the mean of three consecutive measurements will be calculated.
Measured: 4 weeks postpartum
Blood pressure
Resting systolic and diastolic blood pressure will be taken with an ambulatory blood pressure monitor. Measurements will be taken on participants left arm and the mean of three consecutive measurements will be calculated.
Measured: 12 weeks postpartum
Verbal memory
Assessed using the Rey Auditory Verbal Learning Test.
Measured: Days 0-4 postpartum
Verbal memory
Assessed using the Rey Auditory Verbal Learning Test.
Measured: 2 weeks postpartum
Verbal memory
Assessed using the Rey Auditory Verbal Learning Test.
Measured: 4 weeks postpartum
Verbal memory
Assessed using the Rey Auditory Verbal Learning Test.
Measured: 12 weeks postpartum
Sustained attention and executive functioning
Assessed with the Modified Attention Network Task with accuracy and reaction time as outcome measures.
Measured: Days 0-4 postpartum
Sustained attention and executive functioning
Assessed with the Modified Attention Network Task with accuracy and reaction time as outcome measures.
Measured: 2 weeks postpartum
Sustained attention and executive functioning
Assessed with the Modified Attention Network Task with accuracy and reaction time as outcome measures.
Measured: 4 weeks postpartum
Sustained attention and executive functioning
Assessed with the Modified Attention Network Task with accuracy and reaction time as outcome measures.
Measured: 12 weeks postpartum
Visuospatial working memory
Measured using the Visuospatial n-back with accuracy and reaction time as outcome measures.
Measured: Days 0-4 postpartum
Visuospatial working memory
Measured using the Visuospatial n-back with accuracy and reaction time as outcome measures.
Measured: 2 weeks postpartum
Visuospatial working memory
Measured using the Visuospatial n-back with accuracy and reaction time as outcome measures.
Measured: 4 weeks postpartum
Visuospatial working memory
Measured using the Visuospatial n-back with accuracy and reaction time as outcome measures.
Measured: 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start14 Mar 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lamport, University of Reading
- Investigators
- Daniel Lamport, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890014
- Sponsor's protocol ID
- UReading mothers study
- Status last verified
- Jul 2024
- First submitted
- 25 May 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data may be made available on a platform such as Open Science Framework (www.osf.io) or a data repository linked to academic journals, in accordance with Open Science principles.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diet on Perinatal Mood and Cognition
- ClinicalTrials.gov ID
- NCT05890014
- Acronym / sponsor ID
- UReading mothers study
- Keywords
- Cognition, Mood, Flavonoids, Diet, Postpartum, Blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Jun 2023 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High flavonoid group | Experimental | Dietary Supplement: Flavonoid-rich dietParticipants will be encouraged to consume 2 x flavonoid-rich food items per day from the following list of flavonoid-rich foods across 30-days, above what they already consume each day, typically. Orange juice (190 mls) Grapefruit juice (169mls) Dark chocolate (64g) Spinach (109g) Blueberry (64g) Strawberry (157g) Blackberry (81g) Blackcurrant (61g) Cherries (182g) Plums (90g) Black grapes (142g) Oranges (247g) Black olives (89g) Red grapes (339g) |
| Low flavonoid group | Experimental | Dietary Supplement: Flavonoid-rich dietParticipants will be encouraged to consume 1 x flavonoid-rich food items per day from the following list of flavonoid-rich foods across 30-days, above what they already consume each day, typically. Orange juice (190 mls) Grapefruit juice (169mls) Dark chocolate (64g) Spinach (109g) Blueberry (64g) Strawberry (157g) Blackberry (81g) Blackcurrant (61g) Cherries (182g) Plums (90g) Black grapes (142g) Oranges (247g) Black olives (89g) Red grapes (339g) |
| Control | No intervention | –Participants will be given no instructions regarding adding food items to their diet. They will be encouraged to continue their diet as normal for 30-days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be pregnant (reliant on mothers' self-reporting)
Key exclusion criteria (1 listed)
- Participants beyond 38 weeks of their pregnancy (reliant on mothers' self reporting)
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 |
|---|---|---|
| Flavonoid-rich dietInclusion of foods rich in flavonoids. | Dietary supplement | High flavonoid group, Low flavonoid group |
Primary outcome
Mean depressive symptoms
Time frame: Days 0-4 postpartum
Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.
Mean depressive symptoms
Time frame: 2 weeks postpartum
Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.
Mean depressive symptoms
Time frame: 4 weeks postpartum
Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.
Mean depressive symptoms
Time frame: 12 weeks postpartum
Assessed using scores from the Edinburgh Postnatal Depression Scale measure. Higher scores indicate higher levels of depressive symptoms. This questionnaire contains 10 items where participants rate how they have been feeling over the past 7 days on a 4-point Likert scale. Scores on this scale fall between 0-30 where higher scores indicate worse outcomes. The EPDS was designed for women who are pregnant or have just had a baby and has shown to be an efficient and effective way of identifying patients at risk for perinatal depression. This measure is suitable for use in new mothers and fathers.
Mean state anxiety
Time frame: Days 0-4 postpartum
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.
Mean state anxiety
Time frame: 2 weeks postpartum
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.
Mean state anxiety
Time frame: 4 weeks postpartum
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.
Mean state anxiety
Time frame: 12 weeks postpartum
Assessed using scores from the State-Trait Anxiety Inventory- State scale. Higher scores indicate higher levels of anxiety. This questionnaire is a measure of state and trait anxiety containing 40 items in total (20 for trait; 20 for state). Only the state scale (20 items) will be used in current research to measure situational anxiety. Participants are asked to agree or disagree with anxiety-related statements on a scale of 1-4 where higher scores indicate worse outcomes.
37 secondary outcomes
Mean postpartum-specific anxiety symptoms
Time frame: Days 0-4 postpartum
Mean postpartum-specific anxiety symptoms
Time frame: 2 weeks postpartum
Mean postpartum-specific anxiety symptoms
Time frame: 4 weeks postpartum
Mean postpartum-specific anxiety symptoms
Time frame: 12 weeks postpartum
Mean current affect
Time frame: Days 0-4 postpartum
Mean current affect
Time frame: 2 weeks postpartum
Mean current affect
Time frame: 4 weeks postpartum
Mean current affect
Time frame: 12 weeks postpartum
Mean partner depressive symptoms
Time frame: 0-4 postpartum
Mean partner depressive symptoms
Time frame: 2 weeks postpartum
Mean partner depressive symptoms
Time frame: 4 weeks postpartum
Mean partner depressive symptoms
Time frame: 12 weeks postpartum
Mean subjective memory scores
Time frame: Days 0-4 postpartum
Mean subjective memory scores
Time frame: 2 weeks postpartum
Mean subjective memory scores
Time frame: 4 weeks postpartum
Mean subjective memory scores
Time frame: 12 weeks postpartum
Mean subjective mood scores
Time frame: Baseline only
Subjective sleep scores
Time frame: Days 0-4 postpartum
Subjective sleep scores
Time frame: 2 weeks postpartum
Subjective sleep scores
Time frame: 4 weeks postpartum
Subjective sleep scores
Time frame: 12 weeks postpartum
Blood pressure
Time frame: Days 0-4 postpartum
Blood pressure
Time frame: 2 weeks postpartum
Blood pressure
Time frame: 4 weeks postpartum
Blood pressure
Time frame: 12 weeks postpartum
Verbal memory
Time frame: Days 0-4 postpartum
Verbal memory
Time frame: 2 weeks postpartum
Verbal memory
Time frame: 4 weeks postpartum
Verbal memory
Time frame: 12 weeks postpartum
Sustained attention and executive functioning
Time frame: Days 0-4 postpartum
Sustained attention and executive functioning
Time frame: 2 weeks postpartum
Sustained attention and executive functioning
Time frame: 4 weeks postpartum
Sustained attention and executive functioning
Time frame: 12 weeks postpartum
Visuospatial working memory
Time frame: Days 0-4 postpartum
Visuospatial working memory
Time frame: 2 weeks postpartum
Visuospatial working memory
Time frame: 4 weeks postpartum
Visuospatial working memory
Time frame: 12 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Yes. Anonymized data may be made available on a platform such as Open Science Framework (www.osf.io) or a data repository linked to academic journals, in accordance with Open Science principles.
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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.
Daniel Lamport, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavonoid-rich diet in people with Mood and Mothers, run by University of Reading at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. 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 Kingdom. 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?
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?
Mean depressive symptoms (time frame: Days 0-4 postpartum). The study lists 8 primary outcomes in all. 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 16 Jul 2024.