Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03595280
Other study ID # 2017-1378
Secondary ID R01CA217861
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2018
Est. completion date July 1, 2021

Study information

Verified date October 2021
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The purpose of this study is to test the effects of messages communicating the risks (i.e., health harms, addictiveness) of hookah tobacco delivered via mobile multimedia messaging for promoting hookah tobacco cessation. The study will also compare two messaging approaches, a standard untailored approach where all participants receive the same message content, and a tailored messaging approach where message content is personalized to baseline measures of hookah tobacco use behavior and beliefs and interactively to exchanges that occur via mobile messaging sent and received during the exposure period. The study includes young adults ages 18 to 30 who are current hookah tobacco smokers. Eligible participants are young adults ages 18 to 30 years who have smoked hookah tobacco at least once in the past month, smoke hookah tobacco on at least a monthly basis, and have access to the internet and a personal mobile phone to complete study procedures. Study participants will complete a baseline survey online, and all participants will receive standard information about the risks of hookah tobacco. Then participants will be randomly assigned to one of three groups: control group, untailored message group, tailored message group. Participants in the untailored and tailored message group will receive messages sent to their mobile phones communicating the risks of hookah tobacco for a 6 week period. All participants will complete follow-up surveys online 6 weeks after baseline, 3 months later, and 6 months later.


Recruitment information / eligibility

Status Completed
Enrollment 349
Est. completion date July 1, 2021
Est. primary completion date August 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Hookah tobacco risk messages
Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use.

Locations

Country Name City State
United States Duke University Durham North Carolina
United States Georgetown University Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Georgetown University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03723616 - Reactions to Warnings on Hookah Ads N/A
Completed NCT02147665 - Effects of Hookah Smoking on Blood Flow to the Heart, Muscle and Skin N/A
Recruiting NCT04661683 - Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol N/A
Terminated NCT03616002 - Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function N/A
Completed NCT03096860 - Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure N/A