Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04666285 |
| Other study ID # |
56780 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2021 |
| Est. completion date |
August 1, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
University of Southampton |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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:
1. To collect individual level data relating to health and wellbeing during the COVID-19
pandemic amongst SWS women and their offspring.
2. 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.
3. 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.
