NCT07282418

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
14mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

December 2, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

recreation

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (2)

  • Depressive symptoms

    6 months

  • Fruit and vegetable intake

    6 months

Other Outcomes (2)

  • Substance use

    6 months

  • Delay discounting

    6 months

Study Arms (2)

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.

Behavioral: Recreation Enhancement

Interventions

Recreation Enhancement includes coaching and financial support focused on engaging in recreational activities that may displace cardiometabolic risk behaviors.

Recreation Enhancement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Study Officials

  • Bradley M Appelhans, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradley Appelhans, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Trial within a Cohort - participants enrolled in an observational cohort are selected for subsequent enrollment into a randomized intervention study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations