The main goal of the current project is to adapt an existing stress reduction intervention (an e-health application) to the needs of women with a lower educational level and/or low SES, to enrich it with additional smoking cessation components, and…
ID
Source
Brief title
Condition
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main objectives of the study are, ultimately, smoking cessation (or reduction),
stress reduction, and higher self-perceived health among women with a lower
educational level and/or low SES.
Secondary outcome
Secondary objectives are a greater self-regulation and resilience with regard
to smoking, a sense of control in stressful situations, increased awareness of
responsibility for the child's health, better child attachment, and (enhanced)
intrinsic motivation to maintain behavioral change. We expect participants to
find the intervention attractive and easy to use, and attractiveness and user
friendliness to be positively associated with participant motivation to use HRV
biofeedback.
Background summary
Smoking during pregnancy has many adverse health consequences for the (unborn)
child, is closely linked with stress, and particularly prevalent among women
with a lower educational level and/or low socioeconomic status (SES). Since
most smoking cessation interventions have not been proven effective within this
subpopulation of pregnant women, it is important to provide suitable smoking
cessation interventions for this target group.
Study objective
The main goal of the current project is to adapt an existing stress reduction
intervention (an e-health application) to the needs of women with a lower
educational level and/or low SES, to enrich it with additional smoking
cessation components, and to explore the effectiveness of this intervention/app
with regard to smoking, perceived stress and perceived health within the target
group. The intervention/app will also be tested with regard to secondary
parameters (e.g. self-regulation, resilience and sense of control in stressful
situations) and user experience (i.e. frequency and ease of use,
attractiveness, and motivation).
Study design
The study design is a pretest-posttest design with follow-up three months
postpartum. Pregnant women will be asked to fill out three brief online
questionnaires; one at enrolment (T0), one directly after the intervention (T1;
eight weeks after T0) and one three months postpartum (T2). Main indicators are
smoking pattern, perceived stress, and perceived health. Secondary indicators
include (among others) appeal and usability of the application.
Intervention
The intervention/app is an adaption and extension of an existing e-health
intervention/app (*Time2Breathe*) aimed at stress reduction and comprising a
specific module on pregnancy. This prototype contains stress reducing breathing
techniques by means of visual heart rate variability (HRV)-biofeedback, and
psycho-education regarding stress, relaxation, heart rate variability
(HRV)-biofeedback, and pregnancy. This prototype will be adapted in order to
meet the needs of the target group, and expanded with additional content
regarding smoking cessation support, self-regulation, and a tailored quit plan.
In this process, co-creation (i.e. input from the target group) will be used
through an iterative process.
Study burden and risks
Considering the low frequency of filling out questionnaires, limited length of
the questionnaires, and nature of the items in the questionnaires, this study
does not nudge towards a (temporary) change in participants' normal everyday
life. Given the low intrusive nature of its items we do not expect the
questionnaire to have any (psychological) impact on the participants.
Therefore, in line with the examples and clarifications presented in de
CCMO-notitie 'Gedragswetenschappelijk onderzoek en de WMO' (2001), participants
in this study are not subjected to procedures nor required to follow rules of
behaviour.
No risks are expected with participation, since the intervention (application)
contains information that is based on the current, evidence-based stop-smoking
counselling for pregnant women in the Netherlands. No harmful or adverse
effects are known with respect to HRV-biofeedback. In addition, no
pharmaceuticals or drugs are promoted and no invasive treatment will be used.
Participation in the study will not lead to department from, or delay of
standard treatments or diagnostics.
Smoking cessation and stress reduction benefits both the mother and the
(unborn) child. We therefore consider participation in the research
advantageous for all smoking pregnant women. We ultimately believe that the
benefits of participating in the research by far outweigh any burden or risks.
van der Boechorststraat 7
Amsterdam 1081 BT
NL
van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older;
- Female;
- Pregnant (27 weeks maximum);
- Current smoking status <= smoking (not necessarily on a daily basis, and independently of the number of daily smoked cigarettes).
Exclusion criteria
See remarks under 'Additional comments'.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63025.029.17 |
| OMON | NL-OMON25629 |