IncentivesPhase 1LEMURSSINCT06340841
LEMURS SSI: Evaluation of Behavioral Incentives
A Phase 1 study testing Personal Incentives, Personal Restorative Incentives and Charity Incentives in people with Incentives, run by University of Vermont at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 20 years
- Conditions the study is for
- Incentives
- What is being tested?
- Personal Incentives, Personal Restorative Incentives and Charity Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 31 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current undergraduate student in their first year of school own a mobile device
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont
Burlington, Vermont, 05405
Matthew Price, PhD, 802-656-9196, Matthew.Price@uvm.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Incentives
- Being tested
- Personal Incentives, Personal Restorative Incentives, Charity Incentives, Charity Restorative Incentives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal IncentivesBehavioural
The participant receives incentives directly if they complete an activity on a given day.
Personal Restorative IncentivesBehavioural
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.
Charity IncentivesBehavioural
The participant earns compensation for charity if they complete an activity on a given day.
Charity Restorative IncentivesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual Receives Incentive - No Restorative Incentive | Experimental | Participant receives incentives directly Receives: Behavioral: Personal Incentives |
| Individual Receives Incentive -Restorative Incentive | Experimental | The participant receives incentives directly. There is a restorative incentive if they miss an activity. Receives: Behavioral: Personal Restorative Incentives |
| Charity Receives Incentive - No Restorative Incentive | Experimental | Participant earns money for charity Receives: Behavioral: Charity Incentives |
| Charity Receives Incentive -Restorative Incentive | Experimental | Participant earns money for charity. There is a restorative incentive if they miss an activity. Receives: Behavioral: Charity Restorative Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Completion
Number of wellness activities completed
Measured: up to 6 months
Secondary outcomes (5)
Depression, Anxiety, Stress Scale - 21
Summary Score on Depression Scale, higher scores indicate greater depression
Measured: up to 6 months
Depression, Anxiety, Stress Scale - 21
Summary Score on Anxiety Scale, higher scores indicate greater anxiety
Measured: up to 6 months
Depression, Anxiety, Stress Scale - 21
Summary Score on Stress Scale, higher scores indicate greater stress
Measured: up to 6 months
Warwick-Edinburgh Mental Well-being Scale
Summary Score on the Measure, higher scores indicate better well-being
Measured: up to 6 months
Oura Ring Sleep Index
Biometric Sleep recorded from an Oura Ring, higher scores indicate better sleep
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start12 Feb 2024
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IncentivesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be randomized to one of four incentive conditions and receive rewards based on their completion of such activities. There are two main factors (Recipient x Restoration) that will create four distinct groups.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Price, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340841
- Sponsor's protocol ID
- LEMURS SSI 24
- Acronym
- LEMURSSI
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lived Experiences Measured Using Ring Study: Single Session Intervention to Motivate Behavioral Change
- ClinicalTrials.gov ID
- NCT06340841
- Acronym / sponsor ID
- LEMURSSI / LEMURS SSI 24
- Conditions
- Incentives
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomized to one of four incentive conditions and receive rewards based on their completion of such activities. There are two main factors (Recipient x Restoration) that will create four distinct groups.
| Arm | Type | Receives |
|---|---|---|
| Individual Receives Incentive - No Restorative Incentive | Experimental | Behavioral: Personal IncentivesParticipant receives incentives directly |
| Individual Receives Incentive -Restorative Incentive | Experimental | Behavioral: Personal Restorative IncentivesThe participant receives incentives directly. There is a restorative incentive if they miss an activity. |
| Charity Receives Incentive - No Restorative Incentive | Experimental | Behavioral: Charity IncentivesParticipant earns money for charity |
| Charity Receives Incentive -Restorative Incentive | Experimental | Behavioral: Charity Restorative IncentivesParticipant earns money for charity. There is a restorative incentive if they miss an activity. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current undergraduate student in their first year of school own a mobile device
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal IncentivesThe participant receives incentives directly if they complete an activity on a given day. | Behavioural | Individual Receives Incentive - No Restorative Incentive |
| Personal Restorative IncentivesThe 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. | Behavioural | Individual Receives Incentive -Restorative Incentive |
| Charity IncentivesThe participant earns compensation for charity if they complete an activity on a given day. | Behavioural | Charity Receives Incentive - No Restorative Incentive |
| Charity Restorative IncentivesThe 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. | Behavioural | Charity Receives Incentive -Restorative Incentive |
Primary outcome
Activity Completion
Time frame: up to 6 months
Number of wellness activities completed
5 secondary outcomes
Depression, Anxiety, Stress Scale - 21
Time frame: up to 6 months
Depression, Anxiety, Stress Scale - 21
Time frame: up to 6 months
Depression, Anxiety, Stress Scale - 21
Time frame: up to 6 months
Warwick-Edinburgh Mental Well-being Scale
Time frame: up to 6 months
Oura Ring Sleep Index
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Personal Incentives, Personal Restorative Incentives and Charity Incentives in people with Incentives, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Completion (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.