Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001412 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.
The investigators are proposing the first randomized controlled trial to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their 1st or 2nd trimester of pregnancy (≤28 weeks) from local obstetric clinics, communities, and social media. They will be randomized into either the intervention (N=20) or control group (N=20). The two groups will complete the same number of sessions (6 during pregnancy and 3 postpartum), but focus on different topics. Specifically, the control group will receive instructions on general pregnancy and infant care. The intervention group will receive instructions on general pregnancy and infant care, plus an integrated multicomponent intervention that promotes both smoking cessation and breastfeeding (i.e., education and counseling, monitoring and feedback, and contingent financial incentives). Two female Certified Lactation Counselors (interventionists) will be trained to run study sessions during home visits. Interventionists will provide additional support via phone and text messaging until 6 months postpartum. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum within the duration of this award.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated intervention | Experimental | Integrated intervention of smoking cessation and breastfeeding |
|
| Attention placebo control group | Active Comparator | Instructions on general pregnancy and infant care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated intervention of smoking cessation and breastfeeding | Behavioral | The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Smoking Abstinence | Based on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence). The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (<50 ng/mL). | 6 months postpartum |
| Number of Participants With Reported Intent to Breastfeed | During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II. The question is, "What method do you plan to use to feed your new baby in the first few weeks?" with 4 response options: 1) breastfeeding only (baby will not be given formula), 2) formula feed only, 3) both breastfeed and formula feed, or 4) unsure. We create a binary variable to indicate breastfeeding intentions (option 1 or 3) or other feeding intentions (option 2 or 4). | 35 weeks of pregnancy (the end of pregnancy) |
| Number of Participants Reporting to Breastfeed | During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula. | 6 months postpartum |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaozhong Wen, MD, PhD | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo | Buffalo | New York | 14214 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Integrated Intervention | Integrated intervention of smoking cessation and breastfeeding Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2020 |
Not provided
The 40 eligible participants will be randomized into either the intervention (N=20) or control group (N=20). A sequence of random numbers in blocks of 2 will be used to ensure equal numbers of participants for each group over time.
Not provided
Not provided
Research staff who collect and analyze outcome data will be blinded to participants' group assignments.
| Attention placebo control | Behavioral | Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). |
|
| FG001 |
| Attention Placebo Control Group |
Instructions on general pregnancy and infant care Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Integrated Intervention | Integrated intervention of smoking cessation and breastfeeding Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives. |
| BG001 | Attention Placebo Control Group | Instructions on general pregnancy and infant care Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Pregnancy status | Pregnancy status is verified through testing the levels of human chorionic gonadotropin (hCG) in urine samples. If the urine hCG level is 20 mIU/mL or higher, the test shows a positive result, indicating pregnancy. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Smoking Abstinence | Based on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence). The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (<50 ng/mL). | Posted | Count of Participants | Participants | 6 months postpartum |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Reported Intent to Breastfeed | During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II. The question is, "What method do you plan to use to feed your new baby in the first few weeks?" with 4 response options: 1) breastfeeding only (baby will not be given formula), 2) formula feed only, 3) both breastfeed and formula feed, or 4) unsure. We create a binary variable to indicate breastfeeding intentions (option 1 or 3) or other feeding intentions (option 2 or 4). | Posted | Count of Participants | Participants | 35 weeks of pregnancy (the end of pregnancy) |
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting to Breastfeed | During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula. | Posted | Count of Participants | Participants | 6 months postpartum |
|
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Integrated Intervention | Integrated intervention of smoking cessation and breastfeeding Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Attention Placebo Control Group | Instructions on general pregnancy and infant care Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xiaozhong Wen | State University of New York at Buffalo | 7168296811 | xiaozhon@buffalo.edu |
| Nov 4, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2020 | Oct 25, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D005247 | Feeding Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not pregnant |
|
|
|
| Participants |
|
|