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 womens 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 womens 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 babys 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23006975
Publication citations
-
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.