Brief alcohol intervention to reduce risky drinking in pregnancy: a pilot randomised controlled trial
| ISRCTN | ISRCTN43218782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43218782 |
| Secondary identifying numbers | 10788 |
- Submission date
- 17/08/2011
- Registration date
- 17/08/2011
- Last edited
- 29/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Graeme Wilson
Scientific
Scientific
Institute of Health and Society
21-23 Claremont Place
Newcastle Upon Tyne
NE2 4AA
United Kingdom
| g.b.wilson@ncl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Prevention, Screening |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Scientific title | Brief alcohol intervention to reduce risky drinking in pregnancy: a pilot randomised controlled trial |
| Study acronym | RADiANT |
| Study objectives | 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(s) | 11/NE/0205 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 02/01/2012 |
| Completion date | 31/08/2012 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 02/01/2012 |
| Date of final enrolment | 31/08/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Health and Society
Newcastle Upon Tyne
NE2 4AA
United Kingdom
NE2 4AA
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Midwifery Research Dept
Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Government
National Institute of Health Research (NIHR) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/09/2012 | Yes | No |
Editorial Notes
29/10/2018: The overall trial status has been changed to 'Stopped'.
26/10/2018: No publications found, verifying study status with principal investigator.
