- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06340841
LEMURS SSI: Evaluation of Behavioral Incentives (LEMURSSI)
March 30, 2024 updated by: Matthew Price, University of Vermont
Lived Experiences Measured Using Ring Study: Single Session Intervention to Motivate Behavioral Change
The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities.
Participants will be given a brief SSI that will provide education and strategies to improve a wellness related goal (e.g., improve sleep, improve physical activity, improve mental health).
They will then be asked to select a series of wellness related-behaviors in support of that goal to complete each day (e.g., going for a 20 minute walk, going to bed at a specific time).
Participants will be randomized to one of four incentive conditions and receive rewards based on their completion of such activities.
The aim of the study is to determine which incentive strategy may prove most effective in promoting wellness behaviors.
There are two main factors (Recipient x Restoration) that will create four distinct groups.
Recipient refers to who will receive the incentive - either an individual or a charity.
Restoration refers to what happens when a participant misses a day of completing their goal - they are given a restorative (additional) incentive to participants on the following day or not given such an incentive.
The primary hypothesis is that individuals receiving the incentive with a restorative element will result in significantly more activities completed.
Additional hypotheses regarding differences among the other groups are not made given the lack of prior work on these strategies in this area.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Phase 1
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
-
-
Vermont
-
Burlington, Vermont, United States, 05405
- Recruiting
- University of Vermont
-
Contact:
- Matthew Price, PhD
- Phone Number: 802-656-9196
- Email: Matthew.Price@uvm.edu
-
-
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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Current undergraduate student in their first year of school own a mobile device
Exclusion Criteria:
None
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individual Receives Incentive - No Restorative Incentive
Participant receives incentives directly
|
The participant receives incentives directly if they complete an activity on a given day.
|
|
Experimental: Individual Receives Incentive -Restorative Incentive
The participant receives incentives directly.
There is a restorative incentive if they miss an activity.
|
The participant receives incentives directly if they complete an activity on a given day.
They are given an additional incentive to return to completing activities if they did not complete an activity on a prior day.
|
|
Experimental: Charity Receives Incentive - No Restorative Incentive
Participant earns money for charity
|
The participant earns compensation for charity if they complete an activity on a given day.
|
|
Experimental: Charity Receives Incentive -Restorative Incentive
Participant earns money for charity.
There is a restorative incentive if they miss an activity.
|
The participant earns compensation for charity if they complete an activity on a given day.
They are given an additional incentive for charity to return to completing activities if they did not complete an activity on a prior day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activity Completion
Time Frame: up to 6 months
|
Number of wellness activities completed
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression, Anxiety, Stress Scale - 21
Time Frame: up to 6 months
|
Summary Score on Depression Scale, higher scores indicate greater depression
|
up to 6 months
|
|
Depression, Anxiety, Stress Scale - 21
Time Frame: up to 6 months
|
Summary Score on Anxiety Scale, higher scores indicate greater anxiety
|
up to 6 months
|
|
Depression, Anxiety, Stress Scale - 21
Time Frame: up to 6 months
|
Summary Score on Stress Scale, higher scores indicate greater stress
|
up to 6 months
|
|
Warwick-Edinburgh Mental Well-being Scale
Time Frame: up to 6 months
|
Summary Score on the Measure, higher scores indicate better well-being
|
up to 6 months
|
|
Oura Ring Sleep Index
Time Frame: up to 6 months
|
Biometric Sleep recorded from an Oura Ring, higher scores indicate better sleep
|
up to 6 months
|
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)
February 12, 2024
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
May 31, 2028
Study Registration Dates
First Submitted
March 22, 2024
First Submitted That Met QC Criteria
March 30, 2024
First Posted (Actual)
April 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
March 30, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- LEMURS SSI 24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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