- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055272
A Mobile Text Messaging Intervention for Indoor Tanning Addiction
August 3, 2022 updated by: Georgetown University
The purpose of this study is to test the effects of messages communicating the risks (i.e., health harms, addictiveness) of indoor tanning delivered via mobile text messaging among young adult women ages 18 to 30 years who meet screening criteria for indoor tanning addiction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a two arm randomized controlled trial to test the effects of messages communicating the risks of indoor tanning delivered via mobile text messaging as a strategy for promoting cessation among young adult women who meet screening criteria for indoor tanning addiction.
Eligible participants are young adult women ages 18 to 30 years who meet screening criteria for indoor tanning addiction and have access to the internet and a personal mobile phone to complete study procedures.
Participants will complete baseline measures and then be randomized to the study arms.
The text messaging intervention exposure in the intervention arm will last for four weeks.
The control arm will be given basic indoor tanning education information and will not receive any intervention.
Follow up assessments capturing study outcomes will be administered at 1 month (i.e., immediately post-intervention) and three months post-intervention.
Study Type
Interventional
Enrollment (Actual)
265
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Age between 18 and 30 years
- Meet self-report criteria for tanning addiction
- Has access to the internet to complete study procedures
- Has personal mobile phone to complete study procedures
Exclusion Criteria:
- Male
- Age less than 18 or greater than 30
- Does not meet self-report criteria for tanning addiction
- Does not have access to the internet to complete study procedures
- Does not have a personal mobile phone to complete study procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Text messaging
Participants in the text messaging intervention arm receive mobile text messages communicating the risks of indoor tanning and motivating cessation on their mobile phones
|
Participants in the intervention arm will receive text messages to their mobile phones designed to communicate the risks of indoor tanning and motivate cessation.
The intervention exposure lasts for 4 weeks with messages sent 2 days each week.
It is an interactive intervention that engages participants by asking them to respond to prompts, and sending indoor tanning message content in return on message days.
|
NO_INTERVENTION: Control
Participants in the control arm receive no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation to Quit Indoor Tanning
Time Frame: 1 month follow up
|
Motivation to quit is measured by participant report by a single question with a 1 to 7 response scale.
Higher scores indicate greater motivation to quit and are considered better outcomes.
This question is administered at 1 month follow up and at 3 month follow up.
|
1 month follow up
|
Indoor Tanning Cessation
Time Frame: 1 month follow up
|
Indoor tanning cessation is measured by participant report by a single question asking if participants have stopped indoor tanning completely.
Responses indicating cessation are considered better outcomes.
This item is administered at 1-month follow-up and at 3 month follow up.
|
1 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attempts to Quit Indoor Tanning
Time Frame: 1 month follow up and 3 month follow up
|
Attempts to quit indoor tanning are measured by participant report by a single question asking if participants have attempted to quit indoor tanning since the last assessment.
Responses indicating any attempt(s) to quit are considered a better outcome.
This item is administered at 1 month follow up and at 3 month follow up.
|
1 month follow up and 3 month follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk Appraisals
Time Frame: 1 month follow up and 3 month follow up
|
Perceived risk of harm are measured by asking participants how likely harms are to occur (1 = no chance, 7 = certain to happen).
Worry about harms are measured by asking participants how worried they are about harms of indoor tanning (1 = not at all, 7 = very much).
Greater risk appraisals are considered a better outcome.
The items are administered at 1 month follow up and at 3 month follow up.
|
1 month follow up and 3 month follow up
|
Efficacy Beliefs
Time Frame: 1 month follow up and 3 month follow up
|
Beliefs about the health benefits of quitting indoor tanning, efficacy beliefs, are measured using 6 questions asking about health benefits occurring from quitting indoor tanning (1 = No Chance, 7 = Certain to Happen).
Greater efficacy beliefs are considered a better outcome.
These items are administered at 1 month follow up and at 3 month follow up.
|
1 month follow up and 3 month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 7, 2020
Primary Completion (ACTUAL)
March 31, 2022
Study Completion (ACTUAL)
March 31, 2022
Study Registration Dates
First Submitted
August 1, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (ACTUAL)
August 13, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000474
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We will consider requests to share de-identified IPD individually and according to the investigator's study protocol and institutional data sharing policy.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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