search
Back to results

Activity and Recreation in Communities for Health (ARCH)

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ARCH
Traditional Health Outreach
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ARCH

Traditional Health Outreach

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical activity
Change in daily minutes of moderate-vigorous physical activity measured by accelerometer
Weight loss
Weight change will be calculated as a percentage of baseline weight

Full Information

First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
Rush University Medical Center
Collaborators
University of Chicago
search

1. Study Identification

Unique Protocol Identification Number
NCT06093282
Brief Title
Activity and Recreation in Communities for Health
Acronym
ARCH
Official Title
Activity and Recreation in Communities for Health (ARCH) - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two-arm, parallel group design
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcomes assessors and the Investigators are blinded to individual participants' treatment assignment.
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARCH
Arm Type
Experimental
Arm Description
4-month health outreach intervention to improve depressive symptoms, physical activity, and weight management
Arm Title
Traditional Health Outreach
Arm Type
Active Comparator
Arm Description
4-month health outreach intervention focused on screening, referral to healthcare resources, and support
Intervention Type
Behavioral
Intervention Name(s)
ARCH
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Traditional Health Outreach
Intervention Description
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
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
Change in depressive symptoms on the 10-item version of the Centers for Epidemiological Studies - Depression Scale (CES-D-10)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Physical activity
Description
Change in daily minutes of moderate-vigorous physical activity measured by accelerometer
Time Frame
4 months
Title
Weight loss
Description
Weight change will be calculated as a percentage of baseline weight
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brad Appelhans, PhD
Phone
312-942-3477
Email
brad_appelhans@rush.edu
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Activity and Recreation in Communities for Health

We'll reach out to this number within 24 hrs