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NCT03514602 · ClinicalTrials.gov registry record · NA

Maternal Smoking Cessation and Pediatric Obesity Prevention

A NA study of Pregnancy and Childhood Obesity, sponsored by State University of New York at Buffalo.

Recruiting
Registry status
NA
Development phase
48
Enrollment target
1
Study location

NCT03514602 is a NA study of Pregnancy and Childhood Obesity that is actively recruiting participants, run by State University of New York at Buffalo. The registered enrollment target is 48 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03514602, a NA study of Pregnancy and Childhood Obesity, is actively recruiting participants, sponsored by State University of New York at Buffalo.

RECRUITING
Registry status
NA
Development phase
48 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • BEHAVIORAL Multicomponent behavioral intervention
  • BEHAVIORAL Education only control

Study Locations (1)

New York

  • Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo - Buffalo

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2015-07-01
Est. Completion 2026-12-31
Phase NA

What the Registry Record Tells You About NCT03514602

The ClinicalTrials.gov registry entry for NCT03514602 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (94% lower). The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Pregnancy appearing as the primary indexed condition, and to 2 interventions - of which Multicomponent behavioral intervention is the first listed.

NCT03514602 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT03514602 about?

NCT03514602 is a clinical study titled "Maternal Smoking Cessation and Pediatric Obesity Prevention". 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. Tw...

What is the current status of trial NCT03514602?

This trial is currently recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2015-07-01. Estimated completion is 2026-12-31.

What conditions does trial NCT03514602 study?

This clinical trial studies the following conditions: Pregnancy, Childhood Obesity, Smoking, Cigarette.

What interventions are being tested in trial NCT03514602?

The interventions under investigation include: Multicomponent behavioral intervention (BEHAVIORAL), Education only control (BEHAVIORAL).

Who is sponsoring clinical trial NCT03514602?

This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03514602 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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