Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Temple University.
NCT02602288 is a NA study that has completed, run by Temple University. The registered enrollment target is 396 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Child urine cotinine is a biomarker for assessing secondhand smoke exposure. The investigators anticipate the EXP group will evidence a greater reduction in child urine cotinine over time than the CTL group. Cotinine values were log transformed to normalize distributions.
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 |
What the finished NCT02602288 record still lists
NCT02602288 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Ask, Advise, Refer is the first listed.
NCT02602288 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02602288's enrollment target sits among peer trials
396 268th of 2000 higher than 1,733 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05633615 · 396 participants · Phase 2
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- NCT06227910 · 396 participants · Phase 3
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
- NCT06545331 · 396 participants · Phase 1
Study of XB010 in Subjects With Solid Tumors
- NCT06666790 · 396 participants · NA
DermaSensor Postmarket Surveillance Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia