Condition category
Mental and Behavioural Disorders
Date applied
17/08/2011
Date assigned
17/08/2011
Last edited
02/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Graeme Wilson

ORCID ID

Contact details

Institute of Health and Society
21-23 Claremont Place
Newcastle Upon Tyne
NE2 4AA
United Kingdom
g.b.wilson@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10788

Study information

Scientific title

Acronym

RADiANT

Study hypothesis

RADiANT: Reducing Alcohol Drinking in ANTenatal women v1.0, this study will investigate whether it is possible to recruit and retain pregnant women in a pilot trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. The comparison condition will be the usual advice delivered by midwives. We will train midwives to assess pregnant women’s alcohol consumption and obtain consent from those drinking at risky levels to participate in the pilot trial. A trained alcohol counsellor will deliver the brief intervention which will help women understand the nature of alcohol-related risk to their baby and to themselves and identify simple ways of cutting down on their drinking. Subsequently, we will establish if pregnant women are willing to be followed up in the third trimester of pregnancy and six months after their baby is born. We will also measure women’s alcohol consumption, their quality of life and use of NHS services using validated questionnaires. From medical records we will, with participating women's consent, collect information relating to their social circumstances including their age and the number of children they have had. Lastly, we will also record the baby’s birth weight and the age at which the baby was born measured in terms of the number of weeks of pregnancy, and data on fetal loss and abnormality. The information we collect will be used to determine if it will be possible to conduct a full trial which will measure the impact of brief intervention at reducing risky drinking in pregnancy compared to standard advice delivered by midwives.

Ethics approval

11/NE/0205

Study design

Randomised; Interventional; Design type: Prevention, Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

Brief alcohol advice, Control condition - 5 minutes of simple structured alcohol advice delivered by midwife [Treatment As Usual (TAU)].

Brief alcohol intervention, Experimental condition - 5 minutes of simple structured alcohol advice delivered by midwife (TAU) plus a 20 minute client-centred intervention based on motivational interviewing delivered by alcohol counsellor within 2 weeks of initial appointment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Participants recruited & retained; Timepoint(s): Baseline, 3rd trimester of pregnancy (6 months), 6 months post partum

Secondary outcome measures

Alcohol consumption; Timepoint(s): In third trimester (6 months from baseline)

Overall trial start date

02/01/2012

Overall trial end date

31/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women attending routine antenatal care
2. Women who book an antenatal appointment before 16 weeks gestation
3. Women who are aged 18 years or above
4. Women who provide verbal agreement to be screened for alcohol (written consent is not gathered for screening as this is usual practice in antenatal care)
5. Women who screen positive for risky alcohol use [score of 5+ on the Alcohol Use Disorders Identification Test(AUDIT-C)]
6. Women who give written consent to participate in the research; Target Gender: Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

1. Women with pregnancy complications (e.g. diabetes, congenital anomaly)
2. Women with multiple pregnancies
3. Women who book an antenatal appointment after 16 weeks gestation
4. Women with a history of substance use and/or alcohol dependence
5. Women who do not speak English sufficiently to participate
6. Women who are experiencing a severe mental or physical illness which is likely to impact upon the intervention or ability to be followed-up
7. Women who are already participating in other alcohol-related research
8. Women who lack the cognitive capacity to understand the research and what is involved (and are therefore unable to provide informed consent to participate)

Recruitment start date

02/01/2012

Recruitment end date

31/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health and Society
Newcastle Upon Tyne
NE2 4AA
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Midwifery Research Dept
Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23006975

Publication citations

  1. Protocol

    Wilson GB, McGovern R, Antony G, Cassidy P, Deverill M, Graybill E, Gilvarry E, Hodgson M, Kaner EF, Laing K, McColl E, Newbury-Birch D, Rankin J, Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial., Trials, 2012, 13, 174, doi: 10.1186/1745-6215-13-174.

Additional files

Editorial Notes