Maternal Smoking Cessation and Pediatric Obesity Prevention
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|ClinicalTrials.gov Identifier: NCT03514602|
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity Smoking, Cigarette Pregnancy||Behavioral: Multicomponent behavioral intervention Behavioral: Education only control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicomponent behavioral intervention|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study on Pediatric Obesity Prevention by Maternal Smoking Cessation in Pregnancy and Lactation|
|Actual Study Start Date :||July 1, 2015|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Multicomponent behavioral intervention
The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support.
Behavioral: Multicomponent behavioral intervention
Pregnant patients in the intervention group will receive multicomponent interventions consisting of education, feedback, contingent financial incentives, and peer support. At initial intervention visit, they will choose a quit date within the next 14 days and sign a no-smoking pledge and a no-smoking contract. The contract lists the intervention components, the patient's and the counselor's responsibilities, importance of keeping scheduled visits, and rules on contingent incentives. After the quit date, pregnant women will meet with counselors daily for 5 consecutive days (Monday to Friday) for abstinence monitoring in weeks 1-2. The frequency of abstinence monitoring will decrease to twice a week (Monday and Thursday) in weeks 3-8, weekly in weeks 9-12, and biweekly in weeks 13 until delivery.
Active Comparator: Control
The control group will receive smoking cessation education only.
Behavioral: Education only control
The control group will receive one 60-minute counseling mainly based on a pregnancy-tailored self-help booklet entitled "Need Help Putting Out That Cigarette?" distributed by the American College of Obstetricians and Gynecologists.
- Self-reported Smoking abstinence verified by urine cotinine test [ Time Frame: At end of pregnancy (35 weeks of pregnancy; an average of 10 weeks after intervention) ]Self-reported Smoking abstinence verified by urine cotinine test
- Infant gain in weight-for-length z-score [ Time Frame: from birth to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514602
|Contact: Xiaozhong Wen, MD, PhDfirstname.lastname@example.org|
|United States, New York|
|Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo||Recruiting|
|Buffalo, New York, United States, 14214|
|Contact: Xiaozhong Wen 716-829-6811 email@example.com|
|Contact: Xiaozhong Wen 7168296811|
|Principal Investigator: Xiaozhong Wen, MD, PhD|
|Principal Investigator:||Xiaozhong Wen, MD, PhD||State University of New York at Buffalo|