This project aims to finalize the development (Study A) and to evaluate the efficacy (Study B) of a personal, individually tailored PMPP with interventions directed to stop smoking by 30% and/or alcohol consumption by 20% for women who are planning…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
zwangerschapscomplicaties en ziekten tgv roken en of alcoholgebruik
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study A
-Content evaluation. The content evaluation consists of the following: opinions
on the number and length of the questions and messages, (technical) usability,
readability, comprehensibility, attractiveness and convenience and ease of
navigating through the PMPP, perceived personal relevance, individualization,
accuracy and persuasiveness of the feedback. A debriefing interview with each
woman to gain additional information about usability, applicability and
acceptance will be held.
- Process evaluation: Type of mobile phone, for what services they use their
mobile phone (e.g. calling, SMS, WAP, MMS), frequency of use of these services
are measures of feasibility (% of a sample owning a mobile phone and using
specific mobile phone services) and acceptance (% of those owning a mobile
phone and agreed to provide their mobile phone number to participate). Server
registrations of the number of sent and returned questions and messages and the
speed of response delivers quantitative information on usability and
applicability.
Outcome measures of process and content are compared for different groups of
participants (e.g. socio-economic status, ethnic groups).
Study B
- short term primary outcome: proportion of women who smoke, the proportion of
women who use alcohol, as measured at 1 and 6 months after the start of the
intervention
- long term primary outcome: proportion of women who smoke, the proportion of
women who use alcohol, as measured at +13 months and +18 months after the start
of the intervention (= +1 month and +6 months after the PMPP-interventions has
ended).
Secondary outcome
Study B
(1) if case of no cessation: the amount of reduction in smoking and/or a
reduction in alcohol use;
(2) outcomes of biomedical measurements and blood sampling; both assessed at
baseline, +1, +6, +13 and +18 months after start of the intervention.
For analytical purposes, participants who both smoke and use alcohol are
considered a primary success if at least one of these risk factors is stopped.
Differential effects according to the interventions on smoking and/or alcohol
in the same person, pregnancy, ethnicity, and SES will be further explored.
Background summary
In The Netherlands around 30% of women in reproductive ages smoke and more than
80% consume alcohol. Often these risk factors coincide, approximately 90% of
smokers also consume alcohol. Besides the contribution to cardiovascular
disease and cancer, smoking and alcohol use also detrimentally effect
fertility, pregnancy course and birth outcomes. Therefore, women planning
pregnancy are recommended to stop smoking and alcohol already in the
preconception period. Nevertheless, Dutch studies show that during pregnancy
approximately 25% of women still smoke and >35% still use alcohol. Therefore,
there is plenty room for improvement. Despite current preconception care
initiatives, in which women planning pregnancy are informed and advised to stop
smoking and using alcohol, changing these behaviors is very difficult. In this
context, new e-health communication channels enabling interactive and
personalized health communications are very promising. The mobile phone, in
particular the short message service (SMS), has the potential to reach many
individuals at any desired time and place in order to provide personally
tailored information that can contribute to a healthier lifestyle. The
development of lifestyle programs on the mobile phone (PMPP) supported by
(mobile) Internet, however, is still in its infancies and absent for women
planning pregnancy. Furthermore, research on its usability and efficacy is
scarce. Therefore, the PMPP directed to stop smoking and alcohol consumption
can be an important first step towards more comprehensive interactive lifestyle
interventions in these highly motivated young women that are planning
pregnancy.
Study objective
This project aims to finalize the development (Study A) and to evaluate the
efficacy (Study B) of a personal, individually tailored PMPP with interventions
directed to stop smoking by 30% and/or alcohol consumption by 20% for women
who are planning pregnancy. The harmful effects of these unhealthy behaviors on
reproduction are regarded the strongest *motivation*, and the preconception
period as *the window of opportunity* to reach this goal.
Study design
The project is divided in three phases.
In Study A (Development,7 months) the PMPP will be tested for usability,
appreciation, acceptance and feasibility in a step-wise formative evaluation
in 100 women of the target group. After screening on folic acid use, vegetable
and fruit intake, smoking and alcohol use, baseline information on
demographics, health status, cognitive determinants and other lifestyles will
be obtained by questionnaires. After 1 and 3 months intervention,
questionnaires for post-test evaluation will be filled out. Blood samples will
be taken for compliance.
In Study B (Efficacy, 34 months), efficacy on smoking cessation by 30% and
reduction of alcohol consumption by 20% will be tested in a randomized
controlled trial with the PMPP intervention (tailored feedback aimed at
motivation, action initiation and maintenance advice through 12 months And
conventional preconception care)and one control intervention (conventional
preconception care only). The same target group will be enroled and screened on
smoking and alcohol use. Next, the participants are allocated to either the
PMPP intervention (n=219) or to the control intervention (n=219. In both
groups, base line information will be obtained on demographics, health status,
pregnancy, smoking, alcohol, cognitive determinants and other lifestyles by
questionnaires. Questionnaires to evaluate efficacy will be filled out 1, 6
(short-term), 13 and 18 months (long-term) after study entry. Blood samples
will be taken for compliance, e.g., cotinine.
Intervention
PMPP: Intervention on the lifestyle factors (folic acid, vegetables, fruits,
alcohol, smoking) is based on (mobile) internet and SMS
Study burden and risks
Besides the very small risk of standard venapuncture there are no significant
risks to be expected from the intervention with PMPP.
It is very likely that a significant contribution to the future primary and
secondary prevention of subfertility and adverse pregnancy course and birth
outcomes by preconception smoking cessation and reduction of alcohol use in
women planning pregnancy can be gained.
When the PMPP turns out to be unsuccessful (proof of principle), it is
questionable whether it has to be further developed for the general population
to reduce cardiovascular disease and cancer in later life.
Dr Molewaterplein 40
3015 GD Rotterdam
NL
Dr Molewaterplein 40
3015 GD Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Dutch language in word, reading and understanding
pregnancy wish
alcohol use
smoking
Exclusion criteria
Not familiar with the Dutch language
no pregnancy wish
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 | NL22724.078.08 |