NCT01995097

Brief Summary

Primary Aim: To test the efficacy of a SMS text-based scheduled gradual reduction (SGR) and counseling intervention to promote smoking cessation in the late third trimester. Hypothesis: The rate of smoking cessation in the late third trimester among women in the SGR Support Messages arm will be higher than among women in the Support Messages arm. Secondary Aim 1: To assess the effect of the SGR intervention on biochemically validated prolonged abstinence and smoking reduction during pregnancy. Secondary Aim 2: To assess the effect of the SGR intervention on smoking abstinence at three months postpartum. Secondary Aim 3: To assess the effect of the SGR intervention on the rate of preterm birth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
Last Updated

February 8, 2019

Status Verified

December 1, 2017

Enrollment Period

3.8 years

First QC Date

November 20, 2013

Last Update Submit

February 6, 2019

Conditions

SmokingPregnancy

Keywords

smoking cessationsmoking reductionscheduled gradual reductionpregnancytext message intervention

Outcome Measures

Primary Outcomes (1)

  • biochemically validated seven-day point prevalence smoking abstinence

    late third trimester (35 weeks)

Secondary Outcomes (4)

  • prolonged smoking abstinence

    late third trimester (35 weeks gestation)

  • biochemically validated smoking reduction

    late third trimester (35 weeks gestation)

  • biochemically validated postpartum smoking abstinence

    3 months postpartum

  • preterm birth

    delivery

Study Arms (2)

SGR + Support Messages

EXPERIMENTAL

scheduled gradual reduction text messages for first 3-5 weeks of participation; support text messages through 35th week of pregnancy

Behavioral: Scheduled Gradual Reduction Text MessagesBehavioral: Support Text Messages

Support Messages Only

ACTIVE COMPARATOR

support text messages through 35th week of pregnancy

Behavioral: Support Text Messages

Interventions

Scheduled Gradual Reduction Text MessagesBEHAVIORAL
SGR + Support Messages
Support Text MessagesBEHAVIORAL
SGR + Support MessagesSupport Messages Only

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who:
  • are between 10 and 28 weeks pregnant,
  • have smoked at least 100 cigarettes in their lifetime,
  • smoke 3 or more cigarettes per day in the prior 7 days,
  • are current smokers,
  • are willing to try to quit smoking,
  • are enrolled in prenatal care at the clinics from which the study team is recruiting and plan to receive care there throughout their pregnancy,
  • are age 18 or older,
  • speak English

You may not qualify if:

  • \- evidence of unstable cognitive or mental health problems who cannot properly provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

  • Kennedy DL, Lyna P, Gao X, Noonan D, Bejarano Hernandez S, Fish LJ, Swamy GK, Pollak KI. Effects of Smoking Reduction and Cessation on Birth Outcomes in a Scheduled Gradual Reduction Cessation Trial. Matern Child Health J. 2022 May;26(5):963-969. doi: 10.1007/s10995-022-03386-6. Epub 2022 Mar 2.

    PMID: 35235142DERIVED

  • Noonan D, Lyna P, Kennedy DL, Gao X, Bejarano Hernandez S, Fish LJ, Pollak KI. Trajectories of Situational Temptations in Pregnant Smokers participating in a Scheduled Gradual Reduction Cessation Trial. Matern Child Health J. 2022 Jan;26(1):24-30. doi: 10.1007/s10995-021-03321-1. Epub 2021 Dec 3.

    PMID: 34860350DERIVED

  • Pollak KI, Lyna P, Gao X, Noonan D, Hernandez SB, Subudhi S, Kennedy D, Farrell D, Swamy GK, Fish LJ. Pilot Test of Connecting Pregnant Women who Smoke to Short Message Service (SMS) Support Texts for Cessation. Matern Child Health J. 2020 Apr;24(4):419-422. doi: 10.1007/s10995-020-02893-8.

    PMID: 32026323DERIVED

  • Pollak KI, Lyna P, Gao X, Noonan D, Bejarano Hernandez S, Subudhi S, Swamy GK, Fish LJ. Efficacy of a Texting Program to Promote Cessation Among Pregnant Smokers: A Randomized Control Trial. Nicotine Tob Res. 2020 Jun 12;22(7):1187-1194. doi: 10.1093/ntr/ntz174.

    PMID: 31647564DERIVED

MeSH Terms

Conditions

SmokingSmoking CessationSmoking Reduction

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Kathryn Pollak, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

March 1, 2014

Primary Completion

December 13, 2017

Study Completion

February 20, 2018

Last Updated

February 8, 2019

Record last verified: 2017-12

Locations

US(1)