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Maternal Smoking Cessation and Pediatric Obesity Prevention

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
See other at-risk trials from State University of New York at Buffalo

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Site contact updated
    v9
  2. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v8
  3. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v7
  4. Primary completion date: Dec 31, 2022 to Dec 31, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v6
  5. Primary completion date: Dec 31, 2021 to Dec 31, 2022
    • Study completion date: Dec 31, 2022 to Dec 31, 2023
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Primary completion date: Dec 31, 2020 to Dec 31, 2021
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 238 words
    v3
  3. Primary completion date: Dec 31, 2019 to Dec 31, 2020
    • Study completion date: Dec 31, 2020 to Dec 31, 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this study is to test the effect of smoking cessation in pregnancy or in lactation on preventing rapid infant adiposity gain. Investigators propose a randomized, controlled experiment among smoking pregnant women from 1st prenatal care visit through 6 months of postpartum period. Two-phase randomization will be applied to separate the effects of smoking cessation in two different critical periods (i.e., pregnancy and lactation) on infant adiposity gain. Investigators will first randomly assign 40 smoking pregnant women into either the multicomponent intervention (N=30) or the education-only control group (N=10). The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support, while the control group will receive education only. At the end of pregnancy, investigators will further randomize successful quitters (estimated N=20) from the multi-component intervention group into either the continuous multi-component intervention group in lactation (N=10) or the education-only control group (N=10). All women and their newborns will be followed from enrollment to 6 months postpartum. The key outcomes include maternal smoking abstinence confirmed by urine-cotinine and infant gain in weight-for-length z-score. Specific Aim 1 is to examine the effects of maternal smoking cessation intervention in pregnancy on infant gain in weight-for-length z-score from birth to 6 months. Specific Aim 2 is to examine the effect of maternal smoking abstinence intervention in lactation and infant post-weaning gain in weight-for-length z-score among the women who have successfully quit smoking in pregnancy.
Trial Details
NCT Number NCT03514602
Lead Sponsor State University of New York at Buffalo
Conditions
(from sponsor)		 Childhood Obesity, Smoking, Cigarette, Pregnancy
Related terms Cigarette Smoking, Pediatric Obesity
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov