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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.")
Behavioral: Brief Normative Feedback
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.
Behavioral: Loss-framed Text-messaging
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.")
Behavioral: Brief Normative Feedback
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.
Behavioral: Gain-framed Text-messaging
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.")
Behavioral: Brief Normative Feedback
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.
Behavioral: Loss-framed Text-messaging
Daily text-messages on the consequence of hazardous drinking.
Behavioral: Gain-framed Text-messaging
Daily text messages on the benefits of reducing drinking to safe guidelines.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hunter College of City University of New York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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