Activity and Recreation in Communities for Health

NCT06093282 | Enrolling By Invitation

• 1 other identifier: 23080302
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This project tests whether a health outreach intervention that promotes engagement in rewarding, community-based recreational and social activities can produce greater improvements in depressive symptoms, adiposity, and physical activity among people from underresourced communities than traditional health outreach approaches.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms

  Change in depressive symptoms on the 10-item version of the Centers for Epidemiological Studies - Depression Scale (CES-D-10)

  4 months

Secondary Outcomes (2)

• Physical activity

  4 months

• Weight loss

  4 months

Study Arms (2)

ARCH

EXPERIMENTAL

4-month health outreach intervention to improve depressive symptoms, physical activity, and weight management

Behavioral: ARCH

Traditional Health Outreach

ACTIVE COMPARATOR

4-month health outreach intervention focused on screening, referral to healthcare resources, and support

Behavioral: Traditional Health Outreach

Interventions

ARCH BEHAVIORAL

ARCH is a 4-month health outreach intervention that includes the following components: * Screening and referral to address social determinants of health * A 12-session adaptation of Behavioral Activation Treatment for Depression * Weekly contacts from an outreach worker * Optional resources aimed at promoting physical activity and weight management

ARCH

Traditional Health Outreach BEHAVIORAL

The Traditional Health Outreach comparator is a 4-month health outreach intervention that includes the following components: * Screening and referral to address social determinants of health * Support calls from an outreach worker at least once every 3 weeks

Traditional Health Outreach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Member of an underserved population defined by either of the following:
• Received health care at a federally qualified health center within the past 2 years
• Living in a neighborhood with an Area Deprivation Index ≤ 20th percentile
• Elevated depressive symptoms (10-item CES-D score≥10)94,95
• One or both of the following modifiable cardiometabolic risk factors:
• Excess adiposity (body mass index ≥ 28.0 kg/m2)
• Physically inactive according to the 2018 U.S. Physical Activity Guidelines:96 less than 150 minutes of moderate intensity, 75 minutes of vigorous intensity, or an equivalent combination of moderate and vigorous intensity activity, per week based on a 7-day accelerometry protocol

You may not qualify if:

• Under 18 years of age
• Not fluent in English
• Uncontrolled serious mental illness
• High risk for suicidality on the Columbia Suicide Severity Scale
• Conditions jeopardizing staff safety at home data visits
• Individual is dependent on a caretaker for activities of daily living
• Currently lives or plans to move outside Cook and Lake Counties

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of Chicago: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and the Investigators are blinded to individual participants' treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel group design

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available by the end of the project period. However, data that are central to the primary aims of the project will only be shared after the study investigators have had a reasonable period of time to conduct analyses and prepare manuscripts reporting these results. Data will be available for at least 10 years.
• Access Criteria: Access to study will be granted upon review of a written request that summarizes the intended use of the data, the user's qualifications and institutional affiliation, and any required regulatory approval for the planned work by their IRB or other regulatory body. Data that are central to the primary aims of the project, will only be shared after the study investigators have had a reasonable period of time to conduct analyses and prepare manuscripts reporting these results.

Locations

US (1)