Helping Moms Quit Pilot Trial

NCT ID: NCT05041413

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2022-10-05

Brief Summary

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The objective of this study is to test the feasibility and preliminary effectiveness of a tailored text message program to support smoking abstinence among postpartum women who smoke or recently quit.

Detailed Description

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This pilot trial will evaluate a text message intervention (Moms Quit) to be initiated with postpartum women within one month of delivery. Moms Quit is a tailored program to support smoking abstinence among new mothers who are either current smokers or quit during their most recent pregnancy. Investigators will randomize 30 postpartum women, stratified by recent/current smoking status, into Moms Quit versus vs. CONTROL. Investigators hypothesize that participants receiving Moms Quit will have, on average, a significantly longer period of self-reported prolonged abstinence compared to CONTROL.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moms Quit Intervention

12 weeks of the Moms Quit text message intervention

Group Type EXPERIMENTAL

Moms Quit

Intervention Type BEHAVIORAL

Participants will receive text messages tailored on (1) current smoking status and (2) intention to quit/remain quit. Message content includes supportive messaging for child and self-care, relapse prevention, and smoking cessation. Women who are ready to quit will receive messages from the SmokeFreeText library.

Text4Baby

12 weeks of Text4Baby messages

Group Type ACTIVE_COMPARATOR

Text4Baby

Intervention Type BEHAVIORAL

Text4Baby is a free, publicly available text messaging program that provides information about nutrition, safe sleep tips, baby's milestones, signs and symptoms of labor, doctor visit and appointment reminders, breastfeeding advice, car seat safety, information on health insurance, urgent health alerts, and resource hotlines and websites.

Interventions

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Moms Quit

Participants will receive text messages tailored on (1) current smoking status and (2) intention to quit/remain quit. Message content includes supportive messaging for child and self-care, relapse prevention, and smoking cessation. Women who are ready to quit will receive messages from the SmokeFreeText library.

Intervention Type BEHAVIORAL

Text4Baby

Text4Baby is a free, publicly available text messaging program that provides information about nutrition, safe sleep tips, baby's milestones, signs and symptoms of labor, doctor visit and appointment reminders, breastfeeding advice, car seat safety, information on health insurance, urgent health alerts, and resource hotlines and websites.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Less than one month postpartum
* Live delivery
* Smoked at least 100 cigarettes/lifetime
* Smoked anytime during their most recent pregnancy
* English-speaking
* Own a mobile phone
* Provide an email address
* Willing to receive intervention-related texts
* Willing to complete surveys
* Willing to provide a saliva sample at the end of the study

Exclusion Criteria

* Women whose pregnancy did not result in live birth
* On a 7-point scale, participant indicates that they are not interested in quitting or staying quit in the next 6 months (Not at all = 1).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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K01DA040745

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K01DA040745_1

Identifier Type: -

Identifier Source: org_study_id

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