Intervention for mothers during pregnancy to reduce exposure to second-hand smoke
| ISRCTN | ISRCTN18132255 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18132255 |
| Secondary identifying numbers | Protocol v1 |
- Submission date
- 11/02/2024
- Registration date
- 19/02/2024
- Last edited
- 18/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study looks at a special program designed to help pregnant women in India and Bangladesh avoid second-hand smoke at home. Second-hand smoke can be harmful, especially to unborn babies, leading to health problems after birth. The researchers wanted to see if this program, which includes various supportive materials and advice, could make a difference in reducing smoke exposure.
Who can participate?
Pregnant women who don't use tobacco themselves but are around second-hand smoke, confirmed by a saliva test, were invited to join the study. They had to be within the first 20 weeks of their pregnancy to participate.
What does the study involve?
Participants were divided into two groups. One group received a comprehensive package that included educational booklets, personalized messages, feedback on their exposure levels, and one-on-one consultations. The other group got just an educational leaflet. The main goal was to see if this approach could lower the levels of smoke exposure, as measured by a saliva test, three months later. The study also looked at how much the women knew about the risks of second-hand smoke, their confidence in asking family members to smoke less, and how ready they thought their families were to make these changes.
What are the possible benefits and risks of participating?
The big hope was that this program would lead to healthier environments for pregnant women, reducing the risks associated with second-hand smoke. There weren't any significant risks involved in participating, as the study mainly focused on providing information and support.
Where is the study run from?
The research was carried out in two locations: Comilla in Bangladesh and Bangalore in India. These sites were chosen to recruit and study the women involved.
When is the study starting and how long is it expected to run for?
December 2015 to June 2017
Who is funding the study?
1. Medical Research Council (MRC) (UK)
2. Department of Biotechnology (DBT) (India)
It's important to note that these funders didn't influence how the study was conducted or reported.
Who is the main contact?
Atif Rahman, atif.rahman@liverpool.ac.uk
Contact information
Public, Scientific, Principal Investigator
Waterhouse Building Block B
Liverpool
L69 3BX
United Kingdom
| Phone | +44 (0)151 794 2000 |
|---|---|
| atif.rahman@liverpool.ac.uk |
Scientific
Department of Clinical Psychology
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Bangalore
560029
India
 ORCID ID |
0000-0002-9608-2228 |
|---|---|
| Phone | +91 (0)80 26995180 |
| veenas@nimhans.ac.in |
Study information
| Study design | Pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, GP practice |
| Study type | Prevention, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Intervention for Mothers during Pregnancy to Reduce Exposure to Second-hand Smoke (IMPRESS): a pilot randomized controlled trial in Bangladesh and India |
| Study acronym | IMPRESS |
| Study objectives | The aims were to examine the feasibility and acceptability of 1. The study design, measures and methods including delivery of a multicomponent intervention to reduce home exposure to second-hand smoke (SHS) among non-smoking pregnant women 2. The intervention in reducing home exposure to SHS among non-smoking pregnant women from two low- and middle-income countries (LMICs), India and Bangladesh 3. To estimate the standard deviation of the proposed primary outcome measure, to inform sample size calculation for a prospective definitive trial |
| Ethics approval(s) |
1. Approved 01/03/2016, University of Liverpool (Foundation Building, Brownlow Hill, Liverpool, L69 7ZX, United Kingdom; +44 (0)151 794 2000; iphresearch@liverpool.ac.uk), ref: N/A 2. Approved 16/12/2015, National Institute of Mental Health and Neuro Sciences (NIMHANS) (Hosur Road / Marigowda Road, (Lakkasandra, Wilson Garden), Bangalore, 560029, India; +91 (0)80 26995000; dirstaff@nimhans.ac.in), ref: N/A |
| Health condition(s) or problem(s) studied | Second-hand smoke |
| Intervention | Multicomponent behavioural intervention Participants were divided into two groups. Simple 1:1 randomization using computer-generated sequence of random numbers was used. One group received a comprehensive package that included educational booklets, personalized messages, feedback on their exposure levels, and one-on-one consultations. The other group received an educational leaflet. The duration of the intervention was 2 months in the Bangalore site as this had an additional component of voice calls. The duration of follow-up was 3 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Saliva cotinine levels measured using NicAlert® test at baseline and 3-month follow-up |
| Secondary outcome measures | Women’s knowledge of SHS; attitudes to SHS and behaviours to reduce SHS exposure; perceived confidence in negotiating change with husbands and other family members and perceived readiness of their husband to change, measured using researcher-administered knowledge, attitude and behaviour questionnaire at baseline and 3 months |
| Overall study start date | 01/12/2015 |
| Completion date | 01/06/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 100 |
| Total final enrolment | 101 |
| Key inclusion criteria | 1. Women within 20 weeks of pregnancy attending the selected clinics 2. Over 18 years old, reported SHS exposure by their husbands at home 3. Resident in the area and were NicAlert positive |
| Key exclusion criteria | Women using tobacco (smoking or chewing tobacco) |
| Date of first enrolment | 01/11/2016 |
| Date of final enrolment | 01/06/2017 |
Locations
Countries of recruitment
- Bangladesh
- India
Study participating centres
Bangalore
560029
India
Dhaka
1212
Bangladesh
Sponsor information
University/education
Waterhouse Building, Block B
Liverpool
L69 3BX
England
United Kingdom
| Phone | +44 (0)151 794 2000 |
|---|---|
| iphresearch@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The publication will be published in peer-reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Veena A. Satyanarayana (veenas@nimhans.ac.in). The dataset will be shared comprising baseline and follow-up data in Excel format. Written informed consent was sought from participants consenting to participate in the trial. Datasets were pseudo-anonymized before analysis. No individual-level data will be shared in the publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/04/2024 | 18/03/2025 | Yes | No |
Editorial Notes
18/03/2025: Publication reference added.
19/02/2024: Study's existence confirmed by the National Institute of Mental Health and Neuro Sciences (NIMHANS).
