Clinical trial NCT06093282: Activity and Recreation in Communities for Health
Official title: Activity and Recreation in Communities for Health (ARCH) - Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2023-10-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel group design
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms
timeFrame: 4 months
Secondary outcomes:
measure: Physical activity
timeFrame: 4 months
measure: Weight loss
timeFrame: 4 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: