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Trial registered on ANZCTR


Registration number
ACTRN12612000399897
Ethics application status
Approved
Date submitted
16/03/2012
Date registered
10/04/2012
Date last updated
10/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
ENtiCe Project - Encouragement for Nicotine Cessation in pregnant smokers
Scientific title
In a community sample of pregnant women who are current smokers, does receipt of a larger Personal-Financial Incentive compared to a smaller Personal-Financial Incentive and no Personal-Financial Incentive illustrate a trend in increasing cessation rates: A Proof-Of-Concept trial
Secondary ID [1] 280208 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
ENtiCe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking during pregnancy 286147 0
Condition category
Condition code
Public Health 285667 285667 0 0
Health promotion/education
Mental Health 286343 286343 0 0
Addiction
Reproductive Health and Childbirth 286344 286344 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of three trial conditions (smaller incentive vs. larger incentive vs. control). There will be two intervention groups, both of which will involve provding a Personal-Financial Incentive (PFI) to pregnant women who successfully abstain from smoking.

The first intervention will involve a smaller PFI. Women randomly allocated to this first intervention group will be provided with the opportunity to receive a PFI at eight out of 10 study sessions, contingent upon smoking abstinence. This study will involve 10 study sessions 8 of which will be intervention sessions. The amount of the monetary reward will begin at $20 and will increase by a further $20 at every intervention follow-up session participants are found to abstain from smoking. Smoking abstinence will be assessed through a self-report survey and confirmed by saliva cotinine analysis. At each of the eight intervention follow-ups, women who biochemically-validated self-report smoking abstinence will receive their potential incentive for that follow-up period (i.e. $20 for the first follow-up). Eight intervention study sessions where women are eligible to receive a reward will be conducted. They will be conducted at study sessions held during womens scheduled antenatal appointments. These eight intervention study sessions will provide participants with an opportunity to receive a total of $720 if they cease smoking for the entire study period.

The second intervention group will involve a larger PFI. Women randomly allocated to this second intervention group will be provided with the opportunity to receive a PFI at the eight intervention study sessions, contingent upon smoking abstinence. The amount of the monetary reward will begin at $40 and will increase by a further $40 at the eight intervention follow-up participants are found to abstain from smoking. Smoking abstinence will be assessed through a self-report survey and confirmed by saliva cotinine analysis. At each intervention follow-up, women who biochemically-validate self-report smoking abstinence will receive their potential incentive for that follow-up period (i.e. $40 for the first follow-up). Eight study sessions where women are eligible to receive a reward will be conducted (out of a total of 10 sessions). The intervention sessions will be conducted during womens scheduled antenatal appointments. These eight intervention study sessions will provide participants with an opportunity to receive a total of $1440 if they cease smoking for the entire study period.

If a participant in both intervention groups fail to abstain at one of these eight intervention study sessions or do not present for their scheduled follow-up they will not receive the incentive for that period. However the incentive scheme will only ‘re-set’ to the amount the women were previously up to, therefore providing women with an opportunity to receive their incentive during their next intervention study session.
Intervention code [1] 283892 0
Lifestyle
Intervention code [2] 284537 0
Behaviour
Intervention code [3] 284538 0
Prevention
Comparator / control treatment
The third group will be the control group. Women randomly allocated to this group will receive usual care delivered by the midwife. No financial incentive will be offered for quitting smoking. However, self-report smoking, and saliva analysis will be conducted with participants in the control group to assess smoking status.
Control group
Active

Outcomes
Primary outcome [1] 286146 0
Consent rates will be assessed in the form of eligible women who consent to participate in the study.
Timepoint [1] 286146 0
At the completion of the study.
Primary outcome [2] 286147 0
Acceptability of the of method of delivery of a financial incentive (ie. cash payment) to pregnant women.
Timepoint [2] 286147 0
During a follow-up telephone interview after completion of the intervention study, which will be conducted with participants approximately 6 weeks after delivery.
Primary outcome [3] 286148 0
Seven day smoking abstinence, assessed through:
* Self report
* Cotinine saliva analysis
Timepoint [3] 286148 0
During eight intervention study sessions conducted during women's standard antenatal appointment throughout the intervention trial
Secondary outcome [1] 295234 0
Long-term smoking abstinence (during study period) assessed by hair cotinine levels.
Timepoint [1] 295234 0
Eight intervention study sessions where women are eligible to receive a reward will be conducted. They will be conducted at study sessions held during women's scheduled antenatal appointments. During the final intervention study session a sample of women's hair will be collected and subsequent cotinine analysis will be conducted on the hair sample to provide an indication of participants long-term smoking abstinence.

Eligibility
Key inclusion criteria
Pregnant women will be considered eligible if they are:
* Aged 16 years or older
* Presenting for their first antenatal visit
* Less than 31 weeks gestation
* Sufficient English to complete the survey
* Current smokers (defined as having smoked in last 7 days and a positive saliva test for cotinine).
Minimum age
16 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women will be ineligible to participate if they:
* Are considered by clinic staff to have a severe cognitive or psychiatric disorder
* Currently being treated for chemical dependency other than alcohol or tobacco
* Have quit smoking before their first antenatal appointment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Ninety consenting pregnant women, who self-report smoking will be randomised to one of three trial conditions (smaller incentive vs. larger incentive vs. control). Self reported smokers attending an Australian public hospital antenatal clinic will be identified and randomly allocated using block randomisation into one of three groups. saliva cotinine analysis will be used to validate self-reported smoking status. Continuous or long-term smoking cessation will be assessed through hair analysis of patient’s cotinine levels. The unit of randomisation will be the day and session of the patient’s antenatal visit to minimise potential contamination and deception. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of days of the week to study groups was done using Proc Plan in SAS. For each of the 10 weeks the procedure randomly assigned two sessions to each of the 3 treatment groups using a randomised block design.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284380 0
Government body
Name [1] 284380 0
National Heart Foundation of Australia/Grant-in-Aid
Address [1] 284380 0
15 Denison Street
Deakin ACT 2600
Country [1] 284380 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 283313 0
None
Name [1] 283313 0
Address [1] 283313 0
Country [1] 283313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286339 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 286339 0
Hunter New England Research Ethics and Governance Unit
Administration, Ground Floor
Lookout Road
New Lambton, NSW 2305
Ethics committee country [1] 286339 0
Australia
Date submitted for ethics approval [1] 286339 0
31/08/2011
Approval date [1] 286339 0
11/11/2011
Ethics approval number [1] 286339 0
11/09/21/4.05
Ethics committee name [2] 286340 0
University of Newcastle
Ethics committee address [2] 286340 0
Research Services
Research Office
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [2] 286340 0
Australia
Date submitted for ethics approval [2] 286340 0
18/02/2012
Approval date [2] 286340 0
Ethics approval number [2] 286340 0
H-2012-0047

Summary
Brief summary
This study aims to conduct a feasibility trial to test the efficacy of a Personal Financial Incentive (PFI)-based intervention at increasing smoking cessation in pregnant women attending a public hospital for antenatal care. Ninety consenting women will take part in the trial, with 30 women being randomised into one of three groups: the control group, the small PFI group and the larger PFI group. Women in the intervention groups will be eligible to receive a total of eight PFIs, if they successfully abstain from smoking for a 7 day period. Each time a participant in the intervention groups abstains from smoking their PFI will increase. As this is a Proof-Of-Concept study the main aim of the trial is to assess the viability and acceptability of this intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33520 0
Address 33520 0
Country 33520 0
Phone 33520 0
Fax 33520 0
Email 33520 0
Contact person for public queries
Name 16767 0
Dr Marita Lynagh
Address 16767 0
Discipline of Health Behaviour Science
Level 3, Room 341
David Maddison Building
Cnr King & Watt Sts
Newcastle NSW 2300
Country 16767 0
Australia
Phone 16767 0
+61 2 4913 8302
Fax 16767 0
+61 2 4913 8148
Email 16767 0
marita.lynagh@newcastle.edu.au
Contact person for scientific queries
Name 7695 0
Dr Marita Lynagh
Address 7695 0
Discipline of Health Behaviour Science
Level 3, Room 341
David Maddison Building
Cnr King & Watt Sts
Newcastle NSW 2300
Country 7695 0
Australia
Phone 7695 0
+61 2 4913 8302
Fax 7695 0
+61 2 4913 8148
Email 7695 0
marita.lynagh@newcastle.edu.au

No data has been provided for results reporting
Summary results
Not applicable