Activity and Recreation in Communities for Health (ARCH)

Activity and Recreation in Communities for Health (ARCH) - Pilot Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression
• Intervention / Treatment: Behavioral: ARCH; Behavioral: Traditional Health Outreach

Detailed Description

Underresourced communities are affected by structural barriers and detrimental conditions that contribute to disparities in mental and physical health. People living in these communities may also face financial and logistical barriers to engaging in meaningful and rewarding activities in their community, which is linked to risk for depression and cardiometabolic disease in emerging health behavior models. There is also evidence that depression, physical inactivity, and reward-driven overeating exhibit reciprocal causal relationships that promote cardiometabolic disease through multiple pathways, which supports the value of intervening on these co-occurring risk factors simultaneously. Structured interventions that increase engagement in rewarding activities are effective for treating depression, but this approach has not been adapted for broad dissemination in underresourced populations that face challenges accessing the health care system, and have a high burden of cardiometabolic risk factors.

This project will refine and test a novel approach for reducing the burden of depression and cardiometabolic disease in underresourced communities. The Activity and Recreation in Communities for Health (ARCH) intervention is designed to promote engagement in rewarding activities through an adaptation of Behavioral Activation Treatment for Depression, and direct provision of resources to engage in rewarding recreational and social activities both independently and through our partnering community-based organizations. ARCH is designed to be delivered in participants' homes and community venues by a health outreach workforce, which addresses barriers to accessing treatment. Aim 1 is to engage community stakeholders in the process of co-designing ARCH to maximize feasibility, acceptability, and uptake. Aim 2 is to conduct an initial evaluation of the refined ARCH intervention among adults from underresourced communities with depression. Changes in depressive symptoms, adiposity, and physical activity over four months will be compared between those randomly assigned to ARCH versus a traditional health outreach comparator. In addition to clinical outcomes, key metrics of program uptake, cost, and feasibility will be quantified, and hypothesized mechanisms underlying treatment effects will be explored (Aim 3). Findings will inform the design of a definitive implementation trial, and determine the potential value of incorporating behavioral activation in other outreach interventions for underserved populations

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Member of an underserved population defined by either of the following:

   1. Received health care at a federally qualified health center within the past 2 years
   2. Living in a neighborhood with an Area Deprivation Index ≤ 20th percentile
2. Elevated depressive symptoms (10-item CES-D score≥10)94,95

3. One or both of the following modifiable cardiometabolic risk factors:

   1. Excess adiposity (body mass index ≥ 28.0 kg/m2)
   2. 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARCH; 4-month health outreach intervention to improve depressive symptoms, physical activity, and weight management	Behavioral: ARCH; 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
Active Comparator: Traditional Health Outreach; 4-month health outreach intervention focused on screening, referral to healthcare resources, and support	Behavioral: Traditional Health Outreach; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Change in daily minutes of moderate-vigorous physical activity measured by accelerometer	4 months
Weight loss	Weight change will be calculated as a percentage of baseline weight	4 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 23080302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared in accordance with the study's NIH Data Management and Sharing Plan.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No