Cardiometabolic Health IndicatorsPhase 1/2BEARNCT07282418
Behavioral Economic Attributes of Recreation
A Phase 1/2 study testing Recreation Enhancement in people with Cardiometabolic Health Indicators, run by Rush University Medical Center at 1 site in United States.
Trial summary
Risk for developing and dying from heart disease, type 2 diabetes, stroke, and other cardiometabolic conditions is strongly influenced by behavioral risk factors, including poor diet, physical inactivity, and tobacco and alcohol abuse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Health Indicators
- What is being tested?
- Recreation Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to 30 Jun 2027
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Eligibility criteria for BEAR main cohort enrollment (N=120):
- Age 18 years or older
- Fluent in English
- Lives within 10 miles of the study site
- Not planning to move outside the study region in the next 6 months
- Has a working Android or iOS mobile device they are willing to use for EMA surveys and communication with the study team
- No apparent cognitive deficits that would suggest a lack of capacity to consent or complete study procedures
- No uncontrolled serious mental illness, marked by an inpatient hospitalization, increase or change in antipsychotic or mood stabilizing medication, or suicidal intent in the past 6 months.
Eligibility for selection into the RCT component (n=60):
- At least 75% adherence to EMA surveys during the initial assessment
- Complete baseline data within the observational cohort component
- Participant endorses engagement in recreation less than 4 times per week based on EMA surveys
- LE8 score <70, reflecting low to moderate cardiometabolic health.
- No serious substance abuse problem based on an ASSIST score of ≥27 for any substance other than tobacco or cannabis
- Willing and able to try recreational activities for the next 6 months
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
Rush University Medical Center
Chicago, Illinois, 60612
Michele Li, MS, RD, 312-942-8260
About this study
Official title: Behavioral Economic Attributes of Recreation (BEAR): A Pilot Trial Within a Ccohort
Risk for developing and dying from heart disease, type 2 diabetes, stroke, and other cardiometabolic conditions is strongly influenced by behavioral risk factors, including poor diet, physical inactivity, and tobacco and alcohol abuse. Behavioral economic models predict engagement in these behaviors as a function of their subjective value, ability to provide immediate gratification, and availability of competing alternatives. A key implication of the behavioral economic model is that increasing the accessibility of compelling alternative sources of reinforcement may displace engagement in unhealthy behaviors. Developing interventions that leverage these insights requires both a clear understanding of the characteristics of the "reward landscape" of U.S. adults, and the impact of altering the reward landscape on behavioral economic processes and health behavior.
This pilot study uses a trial within a cohort (TwiC) design to pursue these objectives. A representative sample of adults (N=120) will be enrolled into an observational cohort. Cardiometabolic health will be assessed and quantified based on the Life's Essential 8 (LE8) scoring system,4 which includes 4 behavioral (physical activity, diet quality, sleep, tobacco use) and 4 biomedical (non-HDL cholesterol, glucose, weight status, and blood pressure) factors. Structured home audit tools and an ecological momentary assessment (EMA) protocol will be used to measure environmental access to, demand for, and engagement in various rewarding activities, including different categories of recreational activity, electronic entertainment, social activities, and consumable rewards including food, tobacco products, and alcohol. The inter-relationships between different types of rewarding behaviors as substitutes or complements, and their links with cardiometabolic health, will be examined overall and with stratification by socioeconomic status.
Following completion of the first assessment, a subset of participants will be selected for randomization to a recreation-focused intervention or continued observation within the cohort based on their baseline status and protocol adherence. In TwiC designs, the "control" group simply continues to complete observational assessments within the cohort and is not notified that an intervention is ongoing. The BEAR "intervention" group will be approached for consent to participate in a 6-month behavioral economic intervention in which recreational activities are promoted as a strategy to displace cardiometabolic risk behaviors. The scientific aims of the randomized trial component of the study include examining change in LE8 scores, demand for various rewarding activities, discounting rates, and health behaviors. BEAR will also address several feasibility aims, including demonstrating the ability to measure and categorize access to rewarding activities, document recreation-related expenditures by participants, and estimate intervention uptake and acceptability.
Read the detailed description
Behavioral risk factors such as poor diet, physical inactivity, and tobacco and alcohol abuse account for a significant proportion of chronic disease incidence in the U.S. and globally. Understanding the processes that drive engagement in these behaviors could inform individual-level and societal interventions aimed at reducing cardiometabolic risk. Behavioral economics offers several key insights that could be leveraged for this purpose. Contemporary behavioral economic models identify three processes that drive problematic levels of engagement in cardiometabolic risk behaviors:
Demand - the degree to which a behavior is valued or desirable Discounting - immediate rewards are preferred to delayed rewards Choice context - behaviors are selected from the landscape of available options
Individuals vary in the subjective value they place on different rewarding activities. People who find alcohol, drugs of abuse, junk food, and sedentary activity most reinforcing (demonstrate the greatest demand) engage in these behaviors more often. Delay discounting refers to the human preference for immediate rewards, which can lead to instances in which people select less preferred, immediately available options over more valued delayed alternatives. Such occurrences are called preference reversals. Preference reversals lead to engaging in behaviors that provide immediate gratification but increase cardiometabolic risk (e.g., smoking, binge watching TV) for two reasons. First, long-term health outcomes are highly devalued as they always occur months to years in the future relative to the point of decision. Second, competing options that might displace risk behaviors often require planning or preparation, and are therefore less immediately accessible (and therefore discounted in value) at key decision points. For example, the need to plan and prepare to go fishing, engage in a hobby, or socialize with a friend is not trivial compared to the virtually instant access to screens and junk food that most adults have. A third hypothesized influence on cardiometabolic risk behavior is the choice context, or the "reward landscape". Access to alternative reinforcers in the environment can dramatically affect the rate of engaging in target behaviors, particularly if those alternative reinforcers are "behavioral substitutes" that tend to displace the target behavior. A key implication of this behavioral economic model is that increasing access to compelling, immediately available alternative sources of reinforcement may displace engagement in unhealthy behaviors.
To date, interventions based on these insights have mostly focused on reducing substance use. The Icelandic Prevention Model achieved substantial reductions in adolescent substance use at the national level by increasing access to after school recreational programming in local communities. The substance-free activity session is a 2-session intervention that reduces problematic alcohol use by encouraging individuals to identify rewarding alternative behaviors (social activity, recreation, etc). Few studies have applied this approach to improve cardiometabolic health, despite the relevance of the behavioral economic model to eating, sedentary activity, tobacco use, and potentially other cardiometabolic risk factors such as poor sleep, depression, and physical activity.
We recently reported that promoting recreational activities (arts and crafts, puzzles, games, hobbies) as alternative sources of reinforcement reduced children's intake of junk food and use of electronic entertainment in a pilot study with 60 families. Similar studies in adults are lacking. Presumably, recreational activities (broadly defined) represent equally potent alternatives for displacing cardiometabolic risk behaviors in adults.
Interventions that leverage recreation to displace cardiometabolic risk behaviors have strong theoretical support, but further development is needed prior to their implementation. Specifically, intervention development would benefit from a more detailed characterization of the "reward landscapes" of the U.S. adult population. It is known that palatable food and screens dominate most choice contexts, but less is known about the accessibility, cost, and level of demand for various alternative rewarding behaviors, including those available in community settings vs. at home. The Behavioral Economic Attributes of Recreation (BEAR) pilot study includes an observational cohort component aimed at developing methods to characterize the reward landscapes of U.S. adults, and a pilot RCT designed to test preliminary effects of leveraging recreation to displace cardiometabolic risk behaviors.
The following specific aims are proposed:
- Test whether limited access to alternative reinforcing activities such as recreation is a risk factor for cardiometabolic health
- Characterize the association between access to alternative reinforcing activities and Life's Essential 8 (LE8) scores
- Identify specific behavioral pathways (diet, physical activity, sedentary time, sleep) linking recreation to health
- Test whether access to recreation accounts for socioeconomic differences in LE8 scores and cardiometabolic health behaviors
- Determine the relative contribution of community/neighborhood based vs. personal forms of recreation to health
- Examine whether uptake of recreation leads to a reduction in discounting rates or demand for cardiometabolic risk behaviors
- Evaluate the impact of recreation uptake on markers of cardiometabolic health
- Demonstrate the feasibility of relevant methods
- Develop and validate a theoretically meaningful framework for categorizing recreational activities
- Develop and refine a reliable methodology for documenting recreation-related expenditures
- Conditions
- Cardiometabolic Health Indicators
- Being tested
- Recreation Enhancement
- Keywords
- recreation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreation EnhancementBehavioural
Recreation Enhancement includes coaching and financial support focused on engaging in recreational activities that may displace cardiometabolic risk behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Continued observation | No intervention | Participants in the Continued Observation arm will undergo regular assessment visits as part of the larger observational cohort study. |
| Recreation Enhancement | Experimental | Participants in the Recreation Enhancement arm will be supported in identifying and engaging in recreational activities that may displace cardiometabolic risk behaviors. Receives: Behavioral: Recreation Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life's Essential 8 score
The primary clinical outcome is the Life's Essential 8 score (LE8 score). The total LE8 score is derived as the unweighted average of 8 component scores, each ranging from 0-100 based on scoring criteria outlined by Lloyd-Jones et al. The eight components include 4 behavioral (physical activity, diet quality, sleep, tobacco use) and 4 biomedical (non-HDL cholesterol, glucose, weight status, and blood pressure) factors.
Measured: 6 months
Secondary outcomes (2)
Depressive symptoms
The Centers for Epidemiological Studies - Depression - 10-item scale will be used to measure depressive symptoms.
Measured: 6 months
Fruit and vegetable intake
Fruit and vegetable intake will be objectively estimated from skin carotenoids (plant pigments) measured through reflection spectroscopy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start11 May 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Health IndicatorsStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trial within a Cohort - participants enrolled in an observational cohort are selected for subsequent enrollment into a randomized intervention study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Appelhans, Rush University Medical Center
- Investigators
- Bradley M Appelhans, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282418
- Sponsor's protocol ID
- 25110404
- Acronym
- BEAR
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will depend on whether we have resources to support data archiving and secure sharing in the absence of external funding.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Attributes of Recreation (BEAR): A Pilot Trial Within a Ccohort
- ClinicalTrials.gov ID
- NCT07282418
- Acronym / sponsor ID
- BEAR / 25110404
- Conditions
- Cardiometabolic Health Indicators
- Keywords
- recreation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Dec 2025 (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.
Risk for developing and dying from heart disease, type 2 diabetes, stroke, and other cardiometabolic conditions is strongly influenced by behavioral risk factors, including poor diet, physical inactivity, and tobacco and alcohol abuse. Behavioral economic models predict engagement in these behaviors as a function of their subjective value, ability to provide immediate gratification, and availability of competing alternatives. A key implication of the behavioral economic model is that increasing the accessibility of compelling alternative sources of reinforcement may displace engagement in unhealthy behaviors. Developing interventions that leverage these insights requires both a clear understanding of the characteristics of the "reward landscape" of U.S. adults, and the impact of altering the reward landscape on behavioral economic processes and health behavior.
This pilot study uses a trial within a cohort (TwiC) design to pursue these objectives. A representative sample of adults (N=120) will be enrolled into an observational cohort. Cardiometabolic health will be assessed and quantified based on the Life's Essential 8 (LE8) scoring system,4 which includes 4 behavioral (physical activity, diet quality, sleep, tobacco use) and 4 biomedical (non-HDL cholesterol, glucose, weight status, and blood pressure) factors. Structured home audit tools and an ecological momentary assessment (EMA) protocol will be used to measure environmental access to, demand for, and engagement in various rewarding activities, including different categories of recreational activity, electronic entertainment, social activities, and consumable rewards including food, tobacco products, and alcohol. The inter-relationships between different types of rewarding behaviors as substitutes or complements, and their links with cardiometabolic health, will be examined overall and with stratification by socioeconomic status.
Following completion of the first assessment, a subset of participants will be selected for randomization to a recreation-focused intervention or continued observation within the cohort based on their baseline status and protocol adherence. In TwiC designs, the "control" group simply continues to complete observational assessments within the cohort and is not notified that an intervention is ongoing. The BEAR "intervention" group will be approached for consent to participate in a 6-month behavioral economic intervention in which recreational activities are promoted as a strategy to displace cardiometabolic risk behaviors. The scientific aims of the randomized trial component of the study include examining change in LE8 scores, demand for various rewarding activities, discounting rates, and health behaviors. BEAR will also address several feasibility aims, including demonstrating the ability to measure and categorize access to rewarding activities, document recreation-related expenditures by participants, and estimate intervention uptake and acceptability.
Detailed description
Behavioral risk factors such as poor diet, physical inactivity, and tobacco and alcohol abuse account for a significant proportion of chronic disease incidence in the U.S. and globally. Understanding the processes that drive engagement in these behaviors could inform individual-level and societal interventions aimed at reducing cardiometabolic risk. Behavioral economics offers several key insights that could be leveraged for this purpose. Contemporary behavioral economic models identify three processes that drive problematic levels of engagement in cardiometabolic risk behaviors:
Demand - the degree to which a behavior is valued or desirable Discounting - immediate rewards are preferred to delayed rewards Choice context - behaviors are selected from the landscape of available options
Individuals vary in the subjective value they place on different rewarding activities. People who find alcohol, drugs of abuse, junk food, and sedentary activity most reinforcing (demonstrate the greatest demand) engage in these behaviors more often. Delay discounting refers to the human preference for immediate rewards, which can lead to instances in which people select less preferred, immediately available options over more valued delayed alternatives. Such occurrences are called preference reversals. Preference reversals lead to engaging in behaviors that provide immediate gratification but increase cardiometabolic risk (e.g., smoking, binge watching TV) for two reasons. First, long-term health outcomes are highly devalued as they always occur months to years in the future relative to the point of decision. Second, competing options that might displace risk behaviors often require planning or preparation, and are therefore less immediately accessible (and therefore discounted in value) at key decision points. For example, the need to plan and prepare to go fishing, engage in a hobby, or socialize with a friend is not trivial compared to the virtually instant access to screens and junk food that most adults have. A third hypothesized influence on cardiometabolic risk behavior is the choice context, or the "reward landscape". Access to alternative reinforcers in the environment can dramatically affect the rate of engaging in target behaviors, particularly if those alternative reinforcers are "behavioral substitutes" that tend to displace the target behavior. A key implication of this behavioral economic model is that increasing access to compelling, immediately available alternative sources of reinforcement may displace engagement in unhealthy behaviors.
To date, interventions based on these insights have mostly focused on reducing substance use. The Icelandic Prevention Model achieved substantial reductions in adolescent substance use at the national level by increasing access to after school recreational programming in local communities. The substance-free activity session is a 2-session intervention that reduces problematic alcohol use by encouraging individuals to identify rewarding alternative behaviors (social activity, recreation, etc). Few studies have applied this approach to improve cardiometabolic health, despite the relevance of the behavioral economic model to eating, sedentary activity, tobacco use, and potentially other cardiometabolic risk factors such as poor sleep, depression, and physical activity.
We recently reported that promoting recreational activities (arts and crafts, puzzles, games, hobbies) as alternative sources of reinforcement reduced children's intake of junk food and use of electronic entertainment in a pilot study with 60 families. Similar studies in adults are lacking. Presumably, recreational activities (broadly defined) represent equally potent alternatives for displacing cardiometabolic risk behaviors in adults.
Interventions that leverage recreation to displace cardiometabolic risk behaviors have strong theoretical support, but further development is needed prior to their implementation. Specifically, intervention development would benefit from a more detailed characterization of the "reward landscapes" of the U.S. adult population. It is known that palatable food and screens dominate most choice contexts, but less is known about the accessibility, cost, and level of demand for various alternative rewarding behaviors, including those available in community settings vs. at home. The Behavioral Economic Attributes of Recreation (BEAR) pilot study includes an observational cohort component aimed at developing methods to characterize the reward landscapes of U.S. adults, and a pilot RCT designed to test preliminary effects of leveraging recreation to displace cardiometabolic risk behaviors.
The following specific aims are proposed:
- Test whether limited access to alternative reinforcing activities such as recreation is a risk factor for cardiometabolic health
- Characterize the association between access to alternative reinforcing activities and Life's Essential 8 (LE8) scores
- Identify specific behavioral pathways (diet, physical activity, sedentary time, sleep) linking recreation to health
- Test whether access to recreation accounts for socioeconomic differences in LE8 scores and cardiometabolic health behaviors
- Determine the relative contribution of community/neighborhood based vs. personal forms of recreation to health
- Examine whether uptake of recreation leads to a reduction in discounting rates or demand for cardiometabolic risk behaviors
- Evaluate the impact of recreation uptake on markers of cardiometabolic health
- Demonstrate the feasibility of relevant methods
- Develop and validate a theoretically meaningful framework for categorizing recreational activities
- Develop and refine a reliable methodology for documenting recreation-related expenditures
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Trial within a Cohort - participants enrolled in an observational cohort are selected for subsequent enrollment into a randomized intervention study.
| Arm | Type | Receives |
|---|---|---|
| Continued observation | No intervention | –Participants in the Continued Observation arm will undergo regular assessment visits as part of the larger observational cohort study. |
| Recreation Enhancement | Experimental | Behavioral: Recreation EnhancementParticipants in the Recreation Enhancement arm will be supported in identifying and engaging in recreational activities that may displace cardiometabolic risk behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Recreation EnhancementRecreation Enhancement includes coaching and financial support focused on engaging in recreational activities that may displace cardiometabolic risk behaviors. | Behavioural | Recreation Enhancement |
Primary outcome
Life's Essential 8 score
Time frame: 6 months
The primary clinical outcome is the Life's Essential 8 score (LE8 score). The total LE8 score is derived as the unweighted average of 8 component scores, each ranging from 0-100 based on scoring criteria outlined by Lloyd-Jones et al. The eight components include 4 behavioral (physical activity, diet quality, sleep, tobacco use) and 4 biomedical (non-HDL cholesterol, glucose, weight status, and blood pressure) factors.
2 secondary outcomes
Depressive symptoms
Time frame: 6 months
Fruit and vegetable intake
Time frame: 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 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. This will depend on whether we have resources to support data archiving and secure sharing in the absence of external funding.
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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.
Bradley M Appelhans, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recreation Enhancement in people with Cardiometabolic Health Indicators, run by Rush University Medical Center 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?
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 18 Jun 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Bradley Appelhans, PhD (312-942-3477, EatingLab@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life's Essential 8 score (time frame: 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 18 Jun 2026.