- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06126107
Gain and Loss Framed Text Messaging to Reduce Drinking Among Older Adults (GLOSS)
March 10, 2025 updated by: Hunter College of City University of New York
The goal of this study is to evaluate effectiveness of scalable, tailored text- messaging programs for alcohol use among older adults.
This study focuses on gain and loss framing of behavior change goals (i.e., the positives of change and the negatives of remaining with the status quo), critical components of behavioral science and health behavioral interventions.
Loss-framing is used to motivate individuals to avoid future problems by focusing on the consequences of no change in behavior, and gain-framing is used to facilitate progress by focusing on the benefits of change.
The investigators will design and evaluate three text-messaging programs using a randomized controlled trial: (A) Loss-framed messaging (B) Gain-framed messaging; and (C) Combined (loss and gain) messaging among a sample of 150 older adults with hazardous drinking.
Participants will be randomized to one of the three conditions, each of which will include 8 weeks of text-messaging.
During the study participants will completed assessments online and via text messages to track drinking.
Study Overview
Status
Completed
Conditions
Detailed Description
There is an urgent call for efficient and effective assessment, prevention, and intervention among older adults (age 50 and older) to reduce health risk of hazardous drinking, encourage healthy aging, and reduce burden on healthcare systems.
Brief, low-burden, low-cost, digital interventions among older adults can answer this call.
Text-messaging health interventions are considered an effective, scalable way to deliver behavioral health interventions, and they have been used as evidence-based solutions in primary care settings among older adults for behaviors other than alcohol use to supplement traditional care.
Contrary to stereotypes, older adults use mobile technology, seek online and mobile interventions, and often engage longer compared to younger populations.
The primary objective of the proposed study is to evaluate effectiveness of scalable, tailored text- messaging programs for alcohol use among older adults.
This study focuses on gain and loss framing of behavior change goals (i.e., the positives of change and the negatives of remaining with the status quo), critical components of behavioral science and health behavioral interventions.
Loss-framing is used to motivate individuals to avoid future problems by focusing on the consequences of no change in behavior, and gain-framing is used to facilitate progress by focusing on the benefits of change.
The investigators will design and evaluate three text-messaging programs using a randomized controlled trial: (A) Loss-framed messaging (B) Gain-framed messaging; and (C) Combined (loss and gain) messaging among a sample of 150 older adults with hazardous drinking.
Participants will be randomized to one of the three conditions, each of which will last 8 weeks.
Participants will undergo cross- sectional online assessments (baseline, week 4, week 8 and week 16), and they will also complete a mobile assessment (via text message) once per week to track drinking.
The effects of condition on drinking behavior will be compared at weeks 4, 8 and 16.
In addition, attrition from the study will be closely tracked.
Finally, the investigators will explore how the effects condition are impacted by gender and age (via moderation analysis).
Study Type
Interventional
Enrollment (Actual)
133
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
-
-
New York
-
New York, New York, United States, 10035
- Hunter College of CUNY
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be fluent in and able to read English at the eighth grade level
- Between the ages 50 and 85
- Have an estimated average weekly consumption of greater than, for women and men 65 and older, 12, or for men 64 and younger, 15 standard drinks per week
- Be willing to reduce their drinking to non-hazardous levels
- Be willing to provide informed consent
- Own a mobile phone with SMS capability and have an active email address.
- Be willing to receive and respond to up to 120 text messages total per month, as well as four online, web- based surveys.
Exclusion Criteria:
- Demonstrate physiological dependence on alcohol, as evidenced by current or a history of serious physical withdrawal symptoms (e.g., measured by SAWS)
- Present with significant substance use (greater than weekly use) or a current substance use disorder (for any substance other than alcohol, nicotine, or caffeine, measured by self report on Form-90 based questions)
- Present with a serious psychiatric illness or suicide risk, as measured by previous inpatient treatment, medications for mood disorder or psychosis, recent suicidality, and the PHQ-9.
- Unable to understand research study procedures as evidenced by failing a short quiz at the end of reviewing the consent form.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Loss-framed Messaging
Daily text messages on the consequences of hazardous drinking (e.g., "Think of all you have lost as a result of drinking too much.
Make today a day that sets the stage for change.")
|
Once a participant has completed the assessment of their drinking during the baseline battery, the participant will receive brief normative feedback about how their drinking compares to their peers.
Daily text-messages on the consequence of hazardous drinking.
|
|
Active Comparator: Gain-framed Messaging
Daily text messages on the benefits of reducing drinking to safe guidelines (e.g., "Think of all you can achieve if you can control your drinking.
Make today a day that sets the stage for change.")
|
Once a participant has completed the assessment of their drinking during the baseline battery, the participant will receive brief normative feedback about how their drinking compares to their peers.
Daily text messages on the benefits of reducing drinking to safe guidelines.
|
|
Active Comparator: Gain-framed and Loss-framed Messaging
Daily text messages that alternate between loss-framed (e.g., "Think of all you have lost as a result of drinking too much.
Make today a day that sets the stage for change.")
and gain-framed messaging (e.g., "Think of all you can achieve if you can control your drinking.
Make today a day that sets the stage for change.")
|
Once a participant has completed the assessment of their drinking during the baseline battery, the participant will receive brief normative feedback about how their drinking compares to their peers.
Daily text-messages on the consequence of hazardous drinking.
Daily text messages on the benefits of reducing drinking to safe guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly sum of standard drinks
Time Frame: baseline, week 4, week 8, and week 16
|
Measure 1 of drinking, average of weekly sum of standard drinks
|
baseline, week 4, week 8, and week 16
|
|
Weekly sum of heavy drinking days
Time Frame: baseline, week 4, week 8, and week 16
|
Measure 2 of drinking, average of weekly heavy drinking days
|
baseline, week 4, week 8, and week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent adherence to daily drinking assessment via text messages
Time Frame: once daily, starting at baseline, lasting for 8 weeks
|
Responses to text messages (via text message) are considered "adherence" to the daily drinking assessment.
This measure is akin to compliance.
|
once daily, starting at baseline, lasting for 8 weeks
|
|
Percent adherence to weekly drinking assessment via web
Time Frame: once weekly, starting at baseline, lasting 8 weeks
|
Responses to text messages (via text message) are considered "adherence" to the weekly drinking assessment.
This measure is akin to compliance.
|
once weekly, starting at baseline, lasting 8 weeks
|
|
Percent willingness to continue the program for another 8 weeks
Time Frame: At week 8 assessment
|
Participants are asked, "would you like to continue to receive text messages for the next 8 weeks?"
If participants report yes, that is willingness to continue in the program.
If no, then participants are not willing to continue in the program.
|
At week 8 assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alexis Kuerbis, LCSW, PhD, Silberman School of Social Work at Hunter College City, University of New York
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)
February 26, 2024
Primary Completion (Actual)
December 10, 2024
Study Completion (Actual)
December 10, 2024
Study Registration Dates
First Submitted
November 1, 2023
First Submitted That Met QC Criteria
November 8, 2023
First Posted (Actual)
November 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 10, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0653-Hunter
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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