- ICH GCP
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- Klinische proef NCT02412865
Quit4Baby Evaluation (Quit4Baby)
Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers
The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.
In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers who have been recruited from users of text4baby - the first large scale mobile health application in the United States. Developed and operated by Voxiva and Healthy Mothers, Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and delivered more than 150 million health messages to them including messages encouraging them not to smoke during pregnancy and referring them to quit lines.
Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher levels of knowledge about the dangers of second hand smoke and the benefits of smoking cessation for mothers and their infants than text4baby only users.
Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly higher rates of calling a quit line, discussions with their health provider and/or use of cessation counseling than those who receive Text4baby alone.
Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more favorable quitting outcomes compared with text4baby alone.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20052
- The George Washington University
-
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subscribe to the text4baby test messaging program
- Pregnant
- Smoke or recently quit (within last 2 weeks)- Smoking will be defined as self-report of smoking at least one cigarette in the past 7 days. Given that these individuals are recruited from text4baby users, we are confident that they will have cell phones and text messaging capacity.
- Speak English
- Willing to enroll in our study
- 14 years old or older
Exclusion Criteria:
- No longer subscribe to text4baby
- Not pregnant
- Not current smoker (within past 2 weeks)
- Non-English speakers
- Not willing to receive Quit4Baby messages or enroll in study
- Younger than 14 years of age
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Intervention
quit4baby + text4baby
|
|
Ander: Control
text4baby
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Biometrically confirmed abstinence
Tijdsspanne: 3-6 months
|
With saliva cotinine
|
3-6 months
|
Quitline call rates
Tijdsspanne: 1-6 months
|
1-6 months
|
|
Knowledge as measured by survey items
Tijdsspanne: 1-6 months
|
1-6 months
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
- Abroms LC, Johnson PR, Heminger CL, Van Alstyne JM, Leavitt LE, Schindler-Ruwisch JM, Bushar JA. Quit4baby: results from a pilot test of a mobile smoking cessation program for pregnant women. JMIR Mhealth Uhealth. 2015 Jan 23;3(1):e10. doi: 10.2196/mhealth.3846.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- R44 DA035017-0 2
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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