- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04666285
Southampton Women's Survey COVID-19 Study (SWS_COVID-19)
A Survey of Southampton Women's Survey Women's and Offspring's Health and Wellbeing During the COVID-19 Pandemic and Lockdown.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Southampton, United Kingdom, SO16 6YD
- MRC Lifecourse Epidemiology Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women with offspring born in the Southampton Women's Survey (original project)
- Offspring born in the Southampton Women's Survey (original project)
Exclusion Criteria:
- anyone who was not a part of the original project
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental Health in women
Time Frame: 3 months
|
General Health Questionnaire (GHQ-12) - higher score more severe condition
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental Health in offspring
Time Frame: 3 months
|
Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) - higher score describes better mental health
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keith Godfrey, BM, PhD,FRCP, Professor of Human Development and Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 56780
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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