Clinical trial NCT04666285: Southampton Women's Survey COVID-19 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Wellness 1
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 832
Sex: ALL
Minimum age (years): 12
Maximum age (years): 57
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mental Health in women
timeFrame: 3 months
Secondary outcomes:
measure: Mental Health in offspring
timeFrame: 3 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: MRC Lifecourse Epidemiology Unit
Study officials:
affiliation: Professor of Human Development and Health
name: Keith Godfrey, BM, PhD,FRCP
role: PRINCIPAL_INVESTIGATOR
References: