Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890014
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-05
First Post:
2023-05-25
Brief Title:
Effects of Diet on Perinatal Mood and Cognition
Sponsor:
University of Reading
Organization:
University of Reading
Study Overview
Official Title:
Effects of Diet on Perinatal Mood and Cognition
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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 eg 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
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 eg 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None