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NCT02602288 · ClinicalTrials.gov registry record · NA
Babies Living Safe and Smokefree
A NA study, sponsored by Temple University.
- Completed
- Registry status
- NA
- Development phase
- 396
- Enrollment target
NCT02602288 is a NA study that has completed, run by Temple University. The registered enrollment target is 396 participants.
The verdict
NCT02602288, a NA study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- NA
- Development phase
- 396 participants
- Enrollment target
Study Summary
The purpose of this randomized controlled trial is to develop and test the efficacy of a multilevel, multimodal intervention designed to modify maternal smoking behavior to reduce children's exposure to secondhand tobacco smoke (primary outcome) and promote their smoking cessation (secondary outcome). Low-income mothers who smoke will be enrolled. Mothers will be recruited from the supplemental nutrition program, Women, Infants and Children (WIC) clinics. All mothers visiting WIC clinics will receive a clinic-level intervention, which consists of nutrition counselors following an "ask, advise, and refer" protocol to identify if their children are exposed to secondhand tobacco smoke, advise mothers who smoke about the harms of such exposure and the benefits of reducing exposure, and referring mothers to the trial. Screened eligible mothers will be consented and randomized to an attention control condition focused on nutrition (CTL) or to an experimental (EXP) multimodal behavioral intervention that integrates telebased counseling to promote the reduction of child secondhand smoke exposure (SHSE) and maternal smoking with an adjunct smoking cessation mobile app and nicotine replacement therapy use. The investigators will test the primary hypothesis that relative to children in the CTL condition, those in the EXP condition will have lower exposure SHSE as measured by mothers' reports and child cotinine levels. The investigators will also test the secondary hypothesis that relative to mothers in the CTL condition, those in the EXP condition will have higher bioverified 7-day point prevalence quit rates. In addition, the study will: (a) evaluate if specific psychosocial and behavioral factors-- social support, urge coping skills, self-efficacy, and SHSe protective behaviors--mediate the effects of the EXP intervention on outcomes and (b) explore whether other residential smokers, level of nicotine dependence, depressive/anxious symptoms, weight concerns, intervention dos
Interventions
- BEHAVIORAL Ask, Advise, Refer
- BEHAVIORAL Telebased tobacco counseling
- BEHAVIORAL Telebased nutrition counseling
- DEVICE Mobile phone smoking cessation application
- DEVICE Mobile phone nutrition application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2016-02 |
| Est. Completion | 2019-10-23 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02602288
The ClinicalTrials.gov registry entry for NCT02602288 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 396 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ask, Advise, Refer is the first listed.
NCT02602288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02602288 about?
NCT02602288 is a clinical study titled "Babies Living Safe and Smokefree". The purpose of this randomized controlled trial is to develop and test the efficacy of a multilevel, multimodal intervention designed to modify maternal smoking behavior to reduce children's exposure to secondhand tobacco smoke (primary outcome) and promote their smoking cessation (secondary outcome...
What is the current status of trial NCT02602288?
This trial is currently completed. It is a NA study. The enrollment target is 396 participants. The study started on 2016-02. Estimated completion is 2019-10-23.
What interventions are being tested in trial NCT02602288?
The interventions under investigation include: Ask, Advise, Refer (BEHAVIORAL), Telebased tobacco counseling (BEHAVIORAL), Telebased nutrition counseling (BEHAVIORAL), Mobile phone smoking cessation application (DEVICE), Mobile phone nutrition application (DEVICE).
Who is sponsoring clinical trial NCT02602288?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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