ARCH: Activity and Recreation in Communities for Health

Sponsor
Rush University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06093282
Collaborator
University of Chicago (Other)
102
1
2
28.9
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ARCH
  • Behavioral: Traditional Health Outreach
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two-arm, parallel group designTwo-arm, parallel group design
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Outcomes assessors and the Investigators are blinded to individual participants' treatment assignment.
Primary Purpose:
Treatment
Official Title:
Activity and Recreation in Communities for Health (ARCH) - Pilot Study
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Depressive symptoms [4 months]

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

Secondary Outcome Measures

  1. Physical activity [4 months]

    Change in daily minutes of moderate-vigorous physical activity measured by accelerometer

  2. Weight loss [4 months]

    Weight change will be calculated as a percentage of baseline weight

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Member of an underserved population defined by either of the following:

  2. Received health care at a federally qualified health center within the past 2 years

  3. Living in a neighborhood with an Area Deprivation Index ≤ 20th percentile

  4. Elevated depressive symptoms (10-item CES-D score≥10)94,95

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

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

  7. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • Rush University Medical Center
  • University of Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT06093282
Other Study ID Numbers:
  • 23080302
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023