|- candidate number||25672|
|- NTR Number||NTR6305|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-dec-2016|
|- Secondary IDs||MEC-2016-605 METC ErasmusMC Rotterdam|
|- Public Title||PROMISE|
|- Scientific Title||PROMISE
Implementation-pilot trial for smoking cessation counselling among pregnant women|
|- hypothesis||It is expected that PROMISE leads to more enthusaistic natal care professionals for helping preganant women quit smoking and for discussing strategies for smoking cessation more often and that this results in a more effective delivery of stop-smoking counselling. |
|- Healt Condition(s) or Problem(s) studied||Smoking|
|- Inclusion criteria||In order to be eligible to participate in this study, a women must meet all of the following criteria:|
- Being at least 18 years;
- Being female;
- Being pregnant (a maximum of three months);
- Currently smoking or recently quit smoking within the six months before pregnancy;
- Being registered in a practice or hospital that takes part in PROMISE.
|- Exclusion criteria||There are no specific exclusion criteria for this study. The midwife makes an initial assessment whether a women is capable of and willing to participate in PROMISE (which consists of filling out brief questionnaires). |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2017|
|- planned closingdate||1-jan-2019|
|- Target number of participants||250|
|- Interventions||PROMISE is an innovation on the existing stop-smoking counselling for pregnant women, the
‘V-MIS’. PROMISE is adapted to the needs of smoking pregnant women (in particular those of
low socioeconomic status) and professionals (e.g., midwives). Before giving birth, pregnant women will receive smoking cessation counselling from their midwives or gynaecologist. The professional assesses and, if needed, enhances the motivation to quit. A CO-monitor
(comparable with an alcohol breath test and already used by some midwives) may be used
(voluntary) to provide insight in the smoking status (the outcome of these tests will not be
known or used by the research team). The pregnant women receive a ‘workbook’ which
contains all information the professionals have told and in which they can write down their quit
date, potential barriers, action plans etc. In addition, a professional can refer the pregnant
women to more intensive coaching (which is a usual procedure within V-MIS). After giving
birth, women who quit smoking will receive counselling from professionals in maternity care
and youth health care in order to prevent relapse. As multiple professionals are involved during pregnancy and after giving birth, PROMISE also stimulates a clear transfer of womens’ smoking status between midwives / gynaecologists and maternity care / youth heath care.|
|- Primary outcome||The primary objective of PROMISE is that midwives / gynaecologists discuss stop-smoking
strategies with pregnant women more often. |
|- Secondary outcome||Secondary study parameters among midwives / gynaecologists|
- Experience of professionals with stop-smoking counselling (V-MIS and/or PROMISE).
- Some specific PROMSE-related questions are included.
- The overall appreciation and use of (components of) PROMISE.
Secondary study parameters among maternity care professionals
- The implementation of PROMISE among maternity care professionals
- The transfer of the smoking status by midwives or gynaecologists and the transfer
by maternity care professionals to youth health care
- Whether the professionals
smoke during working hours and, if so, whether they smoke in the house of the
- The overall appreciation of PROMISE
Secondary study parameters among youth health care professionals
- The implementation of PROMISE among youth health care professionals
- Whether and how the smoking status
has been transferred to youth health care
- The overall appreciation of PROMISE
Secondary study parameters among (pregnant) women
- Smoking status.
- Smoking behaviour of environment
- Perceived health
- Selected determinants of smoking.
- Birth-related outcomes.
- Exposure to and appreciation of (components of) PROMISE.
|- Timepoints||Midwives and gynaecologists will be asked to fill out six brief online questionnaires: one at
baseline, four after each series of trainings (i.e. at each interval of the stepped wedge
approach) and one two months after the last training.|
Professionals in both maternity care and youth health care will be asked to fill out two
questionnaires: one before they start with PROMISE and one after they supervised their last
participating clients. For maternity care professionals, this will be in the summer of 2018 and for youth health care professionals this will be in December 2018.
The pregnant women fill out three questionnaires:
- Baseline: shortly after their intake at the midwife or gynaecologist;
- 1st follow-up: shortly after childbirth
- 2nd follow-up: six months after childbirth.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Linda Springvloet|
|- CONTACT for SCIENTIFIC QUERIES||MSc Matthijs Blankers|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|Fonds Nuts-Ohra, Ministry of Health, Welfare and Sports|
|- Publications||We intend to publish in national and international peer reviewed journals|
|- Brief summary||Rationale:|
Smoking during pregnancy is in particular prevalent among women with a lower socioeconomic status (SES). Because of the health consequences for the (unborn) child, it is important to provide suitable stop-smoking counselling to these women. In the Netherlands, primary care midwives are required to implement the ‘V-MIS’ stop-smoking counselling in their daily
practice. However, research showed that this counselling program is often not optimally
implemented and is not adapted to new (scientific) insights. In addition, the V-MIS does not continue after pregnancy and hence does not extensively address (the high) relapse after
The main goal of PROMISE is to implement a smoking cessation counselling protocol for natal
care professionals that helps them provide stop-smoking counselling that is suited to their clients. These clients are women who are pregnant or who recently gave birth. Most of these women have a low socioeconomic status. With PROMISE, it is aimed that the natal care professionals become more enthusiastic for helping these women quit smoking and for discussing strategies for smoking cessation more often (primary outcome measure). This might result in a more effective delivery of stop-smoking counselling. This more effective delivery might lead to higher smoking cessation rates among pregnant women (a secondary objective). This research project evaluates this implementation process.
|- Main changes (audit trail)|
|- RECORD||20-dec-2016 - 19-mei-2017|