NCT03595280

Brief Summary

The objective of this study is to examine whether messages conveying the harms and addictiveness of waterpipe (i.e., hookah) tobacco delivered by mobile phone multimedia messaging (MMS) are effective for promoting hookah tobacco cessation among young adults ages 18 to 30 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 28, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 20, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

July 2, 2018

Results QC Date

July 29, 2021

Last Update Submit

October 6, 2021

Conditions

Outcome Measures

Primary Outcomes (7)

  • Perceived Harm

    Perceived harm of hookah tobacco is measured using valid self-report item assessing perceptions of how likely harms are to occur from hookah tobacco use (response range 1 no chance to 7 certain to happen). Greater perceived likelihood of harm is considered a better outcome. The assessment is administered immediately post intervention, 3-month follow-up, and 6-month follow-up, 6 month follow-up data reported.

    6-months

  • Perceived Addictiveness

    Perceived addictiveness of hookah tobacco is measured using valid self-report item assessing perceptions of how likely one is to become addicted to hookah tobacco (1 = no chance, 7 = certain to happen). Greater perceived likelihood of addictiveness is considered a better outcome. The assessment is administered immediately post-intervention, 3-month follow-up, and 6 month follow-up, 6-month follow-up data reported.

    6-months

  • Worry About Harm

    Worry about the harms of hookah tobacco is measured using a valid self-report item assessing how much participants worry about the risks of hookah tobacco (1 = Not at all, 7 = Very much). Greater worry about harm is considered a better outcome. The assessment is administered immediately post-intervention, 3-month follow-up, and 6 month follow-up, 6-month follow-up reported.

    6-months

  • Worry About Addictiveness

    Worry about the addictiveness of hookah tobacco is measured using a valid self-report item assessing how much participants worry about becoming addicted to hookah tobacco (1 = Not at all, 7 = very much). Greater perceived addictiveness is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month-follow-up, 6 month follow-up reported.

    6 months

  • Motivation to Quit

    Motivation to quit is measured using a valid self-report item assessing how much participants want to quit smoking hookah tobacco right now (1 = Not at all, 7 = Very). Greater motivation to quit is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up reported.

    6-months

  • Hookah Tobacco Use Frequency

    Hookah tobacco use frequency is measured using a valid self-report item assessing how often participants have smoked hookah tobacco in the past 30 days. The item measures the number of days in the past month participants have smoked hookah tobacco. Less frequent hookah tobacco use is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up reported.

    6 months

  • Percent of Participants Who Quit Smoking Hookah Tobacco

    Hookah tobacco cessation is measured using a single valid self-report item assessing if participants have stopped smoking hookah tobacco completely. The item asks if participants have completely stopped smoking hookah tobacco based on a yes/no response. Quitting hookah tobacco use (i.e., responses of "yes") is considered a better outcome. The assessment is administered immediately post intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up data reported.

    6 months

Study Arms (3)

Control

NO INTERVENTION

Participants in the control group receive no study messages

Untailored Messages

EXPERIMENTAL

Participants in the untailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones.

Behavioral: Hookah tobacco risk messages

Tailored Messages

EXPERIMENTAL

Participants in the tailored message group receive mobile multimedia service messages conveying the risks of hookah tobacco on their mobile phones that are personalized to their hookah tobacco use behavior and beliefs.

Behavioral: Hookah tobacco risk messages

Interventions

Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use.

Tailored MessagesUntailored Messages

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 30
  • Smoked hookah tobacco within the last 30 days and smokes hookah tobacco on at least a monthly basis
  • Has access the internet to complete study procedures
  • Has personal mobile phone to complete study procedures

You may not qualify if:

  • Age less than 18 or greater than 30
  • Has not smoked hookah tobacco in the last 30 days or does not smoke hookah tobacco on at least a monthly basis
  • Does not have access to the internet to complete study procedures
  • Does not have a personal mobile phone to complete study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Water Pipe Smoking

Condition Hierarchy (Ancestors)

Pipe SmokingSmokingBehavior

Results Point of Contact

Title
Darren Mays
Organization
Georgetown University

Study Officials

  • Darren Mays, PhD, MPH

    Georgetown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a randomized trial with 3 groups: 1) Control group that receives no study messages; 2) Untailored message group that receives general messages about the risks of hookah tobacco; 3) Tailored message group that receives messages about the risks of hookah tobacco that are personalized to their hookah tobacco use behavior and beliefs.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Oncology

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 23, 2018

Study Start

August 28, 2018

Primary Completion

August 1, 2020

Study Completion

July 1, 2021

Last Updated

October 20, 2021

Results First Posted

October 20, 2021

Record last verified: 2021-10

Locations