NCT04009395

Brief Summary

Obesity is on the increase and black Africans in the United Kingdom (UK) make up a significant part of this population (32%). Weight retention after pregnancy is considered as one of the leading causes of obesity. African women living in high-income countries have been found to experience more weight retention after pregnancy than Caucasian women. Healthy eating guidelines have been provided in pregnancy in the UK (National Institute for Health and Care Excellence) and midwives have been placed to provide healthy eating advice in pregnancy, but some studies have identified that African migrants in the UK often eat and prepare food in a different way to the traditional British approach. It has also been observed that the recommended advice for pregnant women, for example, the Eat well plate and start4life are focused on traditional British foods and cooking patterns and do not include food that would be familiar to African migrants. This may impact on the meaningfulness of such guidance to African women. Therefore, this research aims to understand what prevents healthy eating or makes healthy eating easier for pregnant African migrant women in the UK. This would include understanding how healthy eating is interpreted, the cultural factors that are considered important in healthy eating, the current sources of nutrition information and midwives view on providing healthy eating advice to this population. Eligibility

  • Pregnant African migrant women (18 and above) attending ante-natal clinics in NHS hospital sites.
  • Midwives who provide ante-natal advice to pregnant Africans Where Study sites will be hospitals covered by the Epsom and St Helier University trust, London North West University Healthcare National Health Service (NHS) trust and the Lewisham \& Greenwich NHS trusts. How: The study will involve one-on-one interviewing with pregnant women and midwives using hospital spaces provided by the hospital. Focus group discussions with midwives will be attempted depending on logistics. The interviews are expected to last about one hour to one and a half hours. Interview sessions will be audio-taped with the permission of the participants. Data collection is expected to last for 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

June 25, 2019

Last Update Submit

December 9, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of pregnant women who consider healthy eating in pregnancy

    Open ended questions will be used to gain an in depth understanding of factors considered significant to healthy eating (sources of nutrition information, barriers and facilitators) in this population.

    6 months

  • Number of midwives who offer healthy eating advice

    Open ended questions will be used to gain an in depth understanding of the views of mid-wives to provision of healthy eating advice to pregnant African migrants.

    6 months

Study Arms (2)

Pregnant women

One-on-one in-depth interviewing

Other: Pregnant Women qualitative interviewing

Midwives

One-on-one in-depth interviewing or focus group discussions

Other: Midwives qualitative interviewing

Interventions

one-on-one in depth interviewing of pregnant African migrant women living in the UK on the barriers and facilitators to healthy eating in pregnancy.

Pregnant women

one-on-one interviewing/focus group discussions with midwives on their perspectives regarding the provision of healthy eating advice to pregnant African migrant women living in the UK.

Midwives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant migrant African women(18 years and above) living in the UK will be recruited from antenatal clinics in participating NHS study sites. Also midwives who have provided care for pregnant African migrant women will be recruited also from the participating NHS study sites

You may qualify if:

  • Pregnant African migrant women living in the UK (18 years and above) attending antenatal clinics in the study sites. African migrants ethnicity will be self-reported by the participants.
  • Qualified midwives working in study sites who have provided care for African migrants.

You may not qualify if:

  • Pregnant African migrants less than 18 years
  • Pregnant African migrants who have chronic diseases that require dietary management e.g. diabetes, hypertension, coeliac disease.
  • Adults who are unable to communicate in English or pidgin (creole spoken by sub-saharan Africans).
  • Midwives(male or female) who have not directly provided care for pregnant African migrant women will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lewisham and Greenwich NHS Trust

Woolwich, London, SE18 4QH, United Kingdom

Location

Study Officials

  • Aniebiet Ekong

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

July 5, 2019

Study Start

October 29, 2020

Primary Completion

January 5, 2021

Study Completion

April 23, 2021

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data will be shared when publishing results in academic journal papers and in the study protocol.

Shared Documents
STUDY PROTOCOL

Locations