Cash Payment and Counseling During Pregnancy

NCT04572178 | Unknown

• 1 other identifier: Unimed
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking during pregnancy has harmful effects on both mother and unborn child. Studies have shown that small rewards can help smokers to quit. In our current study, we ask how such rewards are most effective in supporting smoking cessation in pregnancy.

Conditions

Smoking Cessation; Pregnancy Related; Incentives

Keywords

Smoking cessation; Pregnancy; Incentives; Counseling; Cash payment

Outcome Measures

Primary Outcomes (1)

• Drop-out rate

  Measure: Analyses of drop-out rate (%)

  Baseline up to pregnancy week 36

Secondary Outcomes (3)

• Differences in number of cigarettes per day by self report

  Baseline up to pregnancy week 36

• Attempts to stop smoking by self report

  Baseline up to pregnancy week 36

• Attempts to stop smoking by carbon monoxide measurement

  Baseline up to pregnancy week 36

Study Arms (1)

Cash payment and brief behavioral counseling

EXPERIMENTAL

The intervention consists of in person counseling and cash payment. The participants receive 25 Euro per week if they have succeeded in quitting smoking. Quitting smoking is evaluated by carbon monoxide measurements twice a week.

Behavioral: Cash payment and brief behavioral counseling

Interventions

Cash payment and brief behavioral counseling BEHAVIORAL

The intervention consists of: (i) in person brief behavioral counseling, (ii) the evaluation of the smoking status using breath carbon monoxide, and (iii) cash payment of 25 Euro if the reading does not exceed a carbon monoxide value "3 ppm" ( ppm = parts per million) on two consecutive measurements per week. The intervention starts at the earliest in pregnancy week 15 and lasts until the delivery. If they relapse, the reward is not paid. However, in the following week they have the opportunity to quit smoking and being rewarded again.

Cash payment and brief behavioral counseling

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current smoking, at least one cigarette per day
• Pregnancy, between pregnancy week 15 and 23

You may not qualify if:

• Inadequate language skills
• Cognitive impairment

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Liselotte-Beutel-Foundation: collaborator
• Ministry of Social Affairs, Integration and gender Equality: collaborator

Study Sites (1)

Institute for Comunity Medicine, Department Prevention Research and Social Medicine

Greifswald, 17475, Germany

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Sabina Ulbricht, Prof. Dr.

  University Medicine Greifswald, Dep. Prevention Research and Social Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabina Ulbricht, Prof. Dr.

CONTACT

+49 (03834) 867732; sabina.ulbricht@med.uni-greifswald.de

Madlèn Steinbrückner

CONTACT

+49 (03834) 8678567; madlen.steinbrückner@med.uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 1, 2020
• Study Start: September 15, 2020
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

DE (1)