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Completed

NCT Number: NCT04666285

Southampton Women's Survey COVID-19 Study

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.

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Key information

Age range

12 year–57 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MRC Lifecourse Epidemiology Unit

Southampton, SO16 6YD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experience of pandemic

Other

Experience of the pandemic will be studied through online questionnaire responses

Primary outcomes

  1. Mental Health in women

    Time frame: 3 months

    General Health Questionnaire (GHQ-12) - higher score more severe condition

Secondary outcomes

  1. Mental Health in offspring

    Time frame: 3 months

    Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) - higher score describes better mental health

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Official study title

A Survey of Southampton Women's Survey Women's and Offspring's Health and Wellbeing During the COVID-19 Pandemic and Lockdown.

Acronym: SWS_COVID-19

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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