Stress- and SmokeFree Start of Life

Phase 2

Conditions: nicotine dependence
smoking addiction
10024450

Registration Number: NL-OMON49559

Lead Sponsor: Vrije Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 259

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'.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main objectives of the study are, ultimately, smoking cessation (or reduction),<br /><br>stress reduction, and higher self-perceived health among women with a lower<br /><br>educational level and/or low SES. We expect that the intervention has a<br /><br>stronger impact on smoking behavior of the women compared to the control<br /><br>condition, indicated by a higher percentage of women who will achieve to stop<br /><br>smoking in the intervention group than in the control group. Moreover, we<br /><br>expect that of women who achieved to quit smoking their experienced stress will<br /><br>be reduced and their experienced health will be increased. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary goals of the study are greater self-regulation and resilience with<br /><br>regard to smoking, a sense of control in stressful situations, increased<br /><br>awareness of responsibility for the health of the child, and better attachment<br /><br>and (enhanced) intrinsic motivation to maintain behavioral change.We expect<br /><br>participants who will be offered the intervention to find the intervention<br /><br>attractive and easy to use, and attractiveness and user friendliness to be<br /><br>positively associated with participant motivation to use HRV biofeedback. Other<br /><br>secondary outcome measures are birth outcomes (including APGAR scores and birth<br /><br>weight), and temperament of the child at 3 months of age. We expect more<br /><br>optimal birth outcomes and temperament outcomes of baby's whose mother achieved<br /><br>to quit smoking than of those whose mother did not achieve to quit smoking. </p><br>