The Effect of Diet on Parents' Mental Health in the Postnatal Period

NCT04990622 | Completed

• 1 other identifier: 2021-082-KB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Postnatal depression (PND) is a type of depression that can occur in some parents after the birth of their baby. PND has been estimated to affect 1 in 10 new parents; mothers in particular are at an increased risk of developing PND in the first year after childbirth. Symptoms of PND include a persistent feeling of sadness or low mood, a lack of enjoyment and loss of interest in the wider world, lack of energy and feeling tired all the time, difficulty bonding with your baby, withdrawing from contact with other people and problems concentrating and making decisions. Research has shown that mothers with PND have more cognitive, behavioural and interpersonal issues, and lower mood, energy and concentration than mothers without PND. Current treatments for PND include self-help resources, support from local and national organisations, psychological therapy or antidepressants with varying success rates. Further research is required to investigate accessible, cost-effective preventions or treatments for new mothers who are at risk or have been diagnosed with PND. There is also a pressing need to investigate natural alternatives to medication, especially for breastfeeding mothers who do not want to expose their infants to pharmaceuticals through breast milk. Flavonoids are naturally occurring compounds found in high levels in foods such as berry and citrus fruits, leafy green vegetables, tea, dark chocolate and red wine. Evidence suggests that consumption of high flavonoid foods can improve health and cognitive outcomes. Prior research investigating daily dietary flavonoid intervention in a postnatal population for 2 weeks indicated significantly higher physical quality of life and significantly lower state anxiety in mothers of infants under 1 year old, at the end of the intervention. These benefits were not observed in the control group. This data shows promise for the management of mood in a key period for mothers and their babies, where risk of PND is high. The research aim of the current study will be to further these investigations to see whether implementation of a high flavonoid diet across a 2 week period positively affects maternal mental health, specifically mood, anxiety, depressive symptoms and perceived quality of life. The study will involve recruiting mothers of infants under 6 months old to take part in an online study investigating diet and mental health. Mothers will be assigned to either a high flavonoid diet or a control condition for 2 weeks. They will complete online questionnaires (Positive and Negative Affect Scale (PANAS), Edinburgh Postnatal Depression Scale (EPDS), Postpartum-Specific Anxiety Scale (PSAS), World Health Organization Quality of Life (WHOQOL), State-Trait Anxiety Inventory (STAI) and Food Frequency Questionnaire (FFQ) at the start (day 0) and end (day 14) of the dietary intervention. In this study, a sub-sample of fathers will also be recruited to take part in the same study to assess if dietary or mood outcomes are similar or different in this population. This pilot data will inform future research of dietary interventions in new fathers. The study does not pose ethical issues. Participants will be asked to complete non-invasive questionnaires about their mood and quality of life. For those in the high flavonoid group the change to diet will not be extreme; this group will be encouraged to include 2 items from a list of high flavonoid foods in their daily food consumption. All participants will be provided with helplines and web links upon debrief should they wish to seek further support. The helplines provided will be Samaritans UK and PANDAs Foundation. Web links to NHS, MIND and the Association for Postnatal Illness will also be listed.

Conditions

Mood; Healthy; Mothers; Fathers; Parents

Keywords

mental health; postpartum; postnatal; diet; dietary intervention; flavonoids; polyphenols

Outcome Measures

Primary Outcomes (2)

• Mean state anxiety

  Assessed using scores from the State-Trait Anxiety Inventory- State scale measure at baseline and 2 weeks. 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.

  2 weeks

• Mean depressive symptoms

  Assessed using scores from the Edinburgh Postnatal Depression Scale at baseline and 2 weeks. 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. 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.

  2 weeks

Secondary Outcomes (3)

• Mean quality of life

  2 weeks

• Mean postpartum-specific anxiety

  2 weeks

• Mean current affect

  2 weeks

Other Outcomes (1)

• General diet

  2 weeks

Study Arms (2)

Dietary 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 2 weeks, above what they already consume each day, typically. * Berry fruits (\~120g) e.g. blueberries, raspberries, strawberries, blackberries, blackcurrants, mixed berries * 2 large squares of dark chocolate (at least 70% cocoa) * 4-5 cups of tea (black or green) or coffee (normal or decaf varieties) * 1 large glass of red wine\* (250ml) * 1 portion of leafy green vegetables such as spinach or cabbage (\~70g) * 1 glass (250ml) of fresh orange or grapefruit juice (not from concentrate)

Dietary Supplement: Flavonoid-rich diet

Control group

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 2 weeks.

Interventions

Flavonoid-rich diet DIETARY_SUPPLEMENT

Inclusion of foods rich in flavonoids.

Also known as: Polyphenol-rich diet

Dietary flavonoid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included if they are a biological parent (mother or father) to an infant who is between 0-6 months old.

You may not qualify if:

• Participants will be excluded if they have cancer, or conditions affecting the liver, heart or kidneys, due to unknown effects on flavonoid metabolism.

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading

Reading, Berkshire, United Kingdom

Location

Related Publications (1)

• Colombage RL, Holden S, Lamport DJ, Barfoot KL. The effects of flavonoid supplementation on the mental health of postpartum parents. Front Glob Womens Health. 2024 Mar 20;5:1345353. doi: 10.3389/fgwh.2024.1345353. eCollection 2024.

  PMID: 38577523 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators who process, score and analyse data will be masked.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: June 28, 2021
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available in Spring 2022.
• Access Criteria: TBC

Locations

GB (1)