Mental Health Wellness 1SWS_COVID-19NCT04666285
Southampton Women's Survey COVID-19 Study
An observational study of Mental Health Wellness 1, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The current COVID-19 pandemic has brought many challenges with implications for wellbeing and mental health. The Southampton Women's Survey provides the opportunity to understand influences on these important outcomes amongst women and their offspring in the context of an established longitudinal cohort study. Read more about this study
- Who is it for?
- Ages 12 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Experience of pandemic
- How many people
- 832 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2021to 1 Aug 2021
- Phase
- Observational
- 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 12 to 57 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Between 1998 and 2002 the Southampton Women's Survey team interviewed 12,583 Southampton women aged 20 to 34 years. Of these participants, 3,158 women subsequently became pregnant within the study period and delivered a liveborn singleton infant.
Who may be able to join
- Women with offspring born in the Southampton Women's Survey (original project)
- Offspring born in the Southampton Women's Survey (original project)
Who cannot join
- anyone who was not a part of the original project
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MRC Lifecourse Epidemiology Unit
Southampton, SO16 6YD
About this study
Official title: A Survey of Southampton Women's Survey Women's and Offspring's Health and Wellbeing During the COVID-19 Pandemic and Lockdown.
The current COVID-19 pandemic has brought many challenges with implications for wellbeing and mental health. The Southampton Women's Survey provides the opportunity to understand influences on these important outcomes amongst women and their offspring in the context of an established longitudinal cohort study.
Read the detailed description
Between 1998 and 2002 the Southampton Women's Survey (SWS) team interviewed 12,583 Southampton women aged 20 to 34 years. The baseline survey collected data on women's diets, lifestyles, body and blood measures, reproductive health, education, mental health and social circumstances. Of these participants, 3,158 women subsequently became pregnant within the study period and delivered a liveborn singleton infant. The survey has followed up the offspring and mothers with home visits at six months, one, two and three years. A sample of over 1,000 offspring was seen at 4 years of age, more than 2,000 offspring were seen at ages 6-7 years, and more than 1,000 at 8-9 years. Follow-up of offspring aged 11-13 years is being completed and at 17-19 years is being piloted.
The women are currently aged 37 to 57 years and the offspring are currently aged 12 to 21 years.
The COVID-19 pandemic has brought unique challenges across the population. The effects include those of the threat of the virus itself as well as the impact of the government-imposed lockdown on health and wellbeing. Research in many contexts will allow greater understanding of the repercussions of this unprecedented event. The Southampton Women's Survey provides an opportunity to understand the effects of the lockdown on a well-characterised cohort of women and their adolescent/young adult offspring. The longitudinal data available in the cohort will provide a unique opportunity to understand how circumstances earlier in life (including pre-pregnancy) influence people's health and wellbeing during the pandemic.
Objectives:
- To collect individual level data relating to health and wellbeing during the COVID-19 pandemic amongst SWS women and their offspring.
- To assess whether lockdown-specific pressures such as working from home, home schooling and lack of social contact are associated with health and wellbeing during the pandemic.
- To use longitudinal data to understand how health and lifestyle in earlier life (including pre-pregnancy) are associated with health and wellbeing during the pandemic.
- Conditions
- Mental Health Wellness 1
- Being tested
- Experience of pandemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experience of pandemicOther
Experience of the pandemic will be studied through online questionnaire responses
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health in women
General Health Questionnaire (GHQ-12) - higher score more severe condition
Measured: 3 months
Secondary outcomes (1)
Mental Health in offspring
Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) - higher score describes better mental health
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Feb 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Godfrey, BM, PhD,FRCP, Principal investigator, Professor of Human Development and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666285
- Sponsor's protocol ID
- 56780
- Acronym
- SWS_COVID-19
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Southampton Women's Survey Women's and Offspring's Health and Wellbeing During the COVID-19 Pandemic and Lockdown.
- ClinicalTrials.gov ID
- NCT04666285
- Acronym / sponsor ID
- SWS_COVID-19 / 56780
- Conditions
- Mental Health Wellness 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 14 Dec 2020 (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 current COVID-19 pandemic has brought many challenges with implications for wellbeing and mental health. The Southampton Women's Survey provides the opportunity to understand influences on these important outcomes amongst women and their offspring in the context of an established longitudinal cohort study.
Detailed description
Between 1998 and 2002 the Southampton Women's Survey (SWS) team interviewed 12,583 Southampton women aged 20 to 34 years. The baseline survey collected data on women's diets, lifestyles, body and blood measures, reproductive health, education, mental health and social circumstances. Of these participants, 3,158 women subsequently became pregnant within the study period and delivered a liveborn singleton infant. The survey has followed up the offspring and mothers with home visits at six months, one, two and three years. A sample of over 1,000 offspring was seen at 4 years of age, more than 2,000 offspring were seen at ages 6-7 years, and more than 1,000 at 8-9 years. Follow-up of offspring aged 11-13 years is being completed and at 17-19 years is being piloted.
The women are currently aged 37 to 57 years and the offspring are currently aged 12 to 21 years.
The COVID-19 pandemic has brought unique challenges across the population. The effects include those of the threat of the virus itself as well as the impact of the government-imposed lockdown on health and wellbeing. Research in many contexts will allow greater understanding of the repercussions of this unprecedented event. The Southampton Women's Survey provides an opportunity to understand the effects of the lockdown on a well-characterised cohort of women and their adolescent/young adult offspring. The longitudinal data available in the cohort will provide a unique opportunity to understand how circumstances earlier in life (including pre-pregnancy) influence people's health and wellbeing during the pandemic.
Objectives:
- To collect individual level data relating to health and wellbeing during the COVID-19 pandemic amongst SWS women and their offspring.
- To assess whether lockdown-specific pressures such as working from home, home schooling and lack of social contact are associated with health and wellbeing during the pandemic.
- To use longitudinal data to understand how health and lifestyle in earlier life (including pre-pregnancy) are associated with health and wellbeing during the pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Between 1998 and 2002 the Southampton Women's Survey team interviewed 12,583 Southampton women aged 20 to 34 years. Of these participants, 3,158 women subsequently became pregnant within the study period and delivered a liveborn singleton infant.
Key inclusion criteria (2 listed)
- Women with offspring born in the Southampton Women's Survey (original project)
- Offspring born in the Southampton Women's Survey (original project)
Key exclusion criteria (1 listed)
- anyone who was not a part of the original project
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 |
|---|---|---|
| Experience of pandemicExperience of the pandemic will be studied through online questionnaire responses | Other | – |
Primary outcome
Mental Health in women
Time frame: 3 months
General Health Questionnaire (GHQ-12) - higher score more severe condition
1 secondary outcome
Mental Health in offspring
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Keith Godfrey, BM, PhD,FRCP principal investigator
Professor of Human Development and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness 1, run by University of Southampton 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 2 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: finished, as of the sponsor's last update on 4 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mental Health in women (time frame: 3 months). 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 4 Oct 2021.