The goal of this study is to develop and test two tailored intervention programs to stimulate pregnant women to stop drinking alcohol. These intervention programs are a health counseling and a computer tailored intervention. The efficacy of the…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameters are: 1. The percentage of women that has stopped
drinking alcohol after 3 months and 6 months on the follow-up; 2. The
percentage of women that lowered the average alcohol intake per week; 3. The
number of glasses of alcohol used per occasion; 4. The average alcohol
consumption during pregnancy.
Secondary outcome
The secondary study parameters are the differences for women with low and high
SES and for women in their first pregnancy or women with one or more children
as well as the effect of the intervention on the partner.
Background summary
Alcohol consumption during pregnancy is a leading preventable cause of birth
defects and developmental disabilities. Harmful effects are found with
individuals whose mothers drink heavily during pregnancy as well as with
individuals whose mothers are light-to-moderate drinkers. Of the 200.000 women
in the Netherlands who become pregnant every year, approximately 35% to 50%
continue to drink alcohol throughout their pregnancy. Thus far, little
attention has been paid to researching potential preventative strategies
designed to reduce prenatal alcohol consumption. The hypothesis of this
research is that interventions from the experimental group will lead to 20% of
the women refraining from alcohol use.
Study objective
The goal of this study is to develop and test two tailored intervention
programs to stimulate pregnant women to stop drinking alcohol. These
intervention programs are a health counseling and a computer tailored
intervention. The efficacy of the interventions is tested by means of a
randomized control trial with three conditions.
Study design
A randomized control trial with three conditions with a baseline assessment and
2 follow-ups, 3 months and 6 months after baseline measurement. Subjects will
be randomly assigned to one of three conditions.
Intervention
The subjects will be randomly assigned to the following conditions:
1: Control condition, consisting of filling out a baseline questionnaire and
two follow-up questionnaires.
2: A Health Counseling intervention, that consists of a developed protocol for
midwives combined with the developed materials for target groups. This
condition implies pregnant women filling out a baseline questionnaire and two
follow-up questionnaires.
3: Computer tailored intervention. This condition implies filling out a
baseline questionnaire and two follow-up questionnaires, and receiving
personalized feedback through internet.
Study burden and risks
The burden for the subjects is to fill out three questionnaires. The Health
Counseling condition also contains counseling during the consult of the
midwife. It is expected that this does not take extra time than a similar
consult without the alcohol counseling. The Computer Tailored intervention
receives personal feedback through internet after filling out the three
questionnaires. Reading this feedback will cost extra time. The interventions
do not involve any risks.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
Female
Pregnant
Drink alcohol
18 years or older
client of a midwife practice
Exclusion criteria
no client of midwife practice
not drinking alcohol
not pregnant
younger than 18
insufficient understanding of Dutch language
illiterate
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28561.068.09 |