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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06340841
Other study ID # LEMURS SSI 24
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 12, 2024
Est. completion date May 31, 2028

Study information

Verified date March 2024
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 31, 2028
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 20 Years
Eligibility Inclusion Criteria: Current undergraduate student in their first year of school own a mobile device Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Personal Incentives
The participant receives incentives directly if they complete an activity on a given day.
Personal Restorative Incentives
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 Incentives
The participant earns compensation for charity if they complete an activity on a given day.
Charity Restorative Incentives
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.

Locations

Country Name City State
United States University of Vermont Burlington Vermont

Sponsors (1)

Lead Sponsor Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Activity Completion Number of wellness activities completed up to 6 months
Secondary Depression, Anxiety, Stress Scale - 21 Summary Score on Depression Scale, higher scores indicate greater depression up to 6 months
Secondary Depression, Anxiety, Stress Scale - 21 Summary Score on Anxiety Scale, higher scores indicate greater anxiety up to 6 months
Secondary Depression, Anxiety, Stress Scale - 21 Summary Score on Stress Scale, higher scores indicate greater stress up to 6 months
Secondary Warwick-Edinburgh Mental Well-being Scale Summary Score on the Measure, higher scores indicate better well-being up to 6 months
Secondary Oura Ring Sleep Index Biometric Sleep recorded from an Oura Ring, higher scores indicate better sleep up to 6 months
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