Multilevel Tobacco Intervention in Community Clinics for Underserved Families
| Registry | NCT02602288, acronym BLiSS |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 396 (Actual) |
| Sponsor | Temple University (Other); collaborators: N.O.R.T.H., Inc. |
| Conditions | Second Hand Tobacco Smoke, Nicotine Dependence |
| Interventions | Ask, Advise, Refer, Telebased tobacco counseling, Telebased nutrition counseling, Mobile phone smoking cessation application, Mobile phone nutrition application, Nicotine polacrilex (Behavioral, device, drug) |
| Dates | start 2016-02-01, primary completion 2019-10-23, completion 2019-10-23, first posted 2015-11-11, last updated 2022-03-15 |
| Locations | 2 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Second Hand Tobacco Smoke All trials for Nicotine Dependence All trials of Ask, Advise, Refer All trials of Telebased tobacco counseling
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 dosage, and pregnancy status predict outcomes and moderate treatment effects.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| AAR+Behavioral Intervention (EXP) | Experimental | Behavioral: Ask, Advise, Refer; Behavioral: Telebased tobacco counseling; Device: Mobile phone smoking cessation application; Drug: Nicotine polacrilex | Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke. Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts. Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form. |
| AAR+Attention Control Intervention (CTL) | Active comparator | Behavioral: Ask, Advise, Refer; Behavioral: Telebased nutrition counseling; Device: Mobile phone nutrition application | Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family. Mobile phone nutrition application: Smartphone based application to support healthy eating habits |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * English speaking * female * at least 18 years of age * parent or legal guardian of child under 6 yrs old who lives with them at least 4 days/wk * smokes Exclusion Criteria: * non-nicotine drug dependence * active psychiatric disturbance (bipolar, schizophrenia, psychosis) * inadequate health literacy * pregnant * no smartphone
| Milestone | AAR+Behavioral Intervention (EXP) | AAR+Attention Control Intervention (CTL) |
|---|---|---|
| Started | 199 | 197 |
| Completed | 174 | 179 |
| Not completed | 25 | 18 |
Time frame: Adverse events were tracked for each participant (enrolled mothers) from the time of the baseline assessment through the 12-month assessment.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| AAR+Behavioral Intervention (EXP) | 0/199 (0.0%) | 0/199 (0.0%) | 0/199 (0.0%) |
| AAR+Attention Control Intervention (CTL) | 0/197 (0.0%) | 0/197 (0.0%) | 0/197 (0.0%) |
Limitations and caveats: Limited generalizability of findings due to high rates of ineligibility (27.7%) and inability to contact (22.7%) among maternal smokers referred to the trial by WIC nutrition professionals who provided the clinic-level intervention.
| Facility | City | Country | Status |
|---|---|---|---|
| Temple University | Philadelphia, Pennsylvania | United States | |
| N.O.R.T.H., Inc. | Philadelphia, Pennsylvania | United States |