Clinical trial NCT05293587: Physical Activity to Reduce Diabetes Risk in Serious Mental Illness
Official title: Physical Activity to Reduce Diabetes Risk in Serious Mental Illness: PARCS Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders, Severe
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Vanderbilt University School of Medicine
name: Kansas State University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist control group
Primary purpose: PREVENTION

Brief summary: The aim of this project is to trial the protocol of a park-based physical activity (PA) intervention in adults with severe mental illness (SMI) in a community mental health center's peer support program.

Detailed description: Aim 1: Test the feasibility and acceptability of a park-based PA intervention led by Certified Peer Specialists (CPS) and adapted for adults with SMI. Rationale: Park-based interventions led by CPSs represent a novel approach to increase program satisfaction and adherence to PA behavior change in persons with SMI. Hypothesis 1A: Most (80%) people offered the intervention will participate most of the time (≥2 day/week). Hypothesis 1B: CPSs and SMI patients will express satisfaction with the program (6 on an 8-point scale). Aim 2: Test the effectiveness of a park-based PA intervention led by CPSs on increasing PA and improving fitness in adults with SMI. Rationale: Park-based PA is associated with greater intensity and duration of PA, better fitness, and less obesity and depression, issues that are especially problematic for adults with SMI. Hypothesis 2A: People enrolled in the intervention will engage in more PA than at baseline (90min moderate to vigorous PA (MVPA)/week). Hypothesis 2B: The intervention will result in improved fitness (6 min walk test) relative to baseline.

Eligibility criteria: Inclusion Criteria:

* Authorized for peer group treatment through the Serenity behavioral health facility
* Medically cleared for participation
* Able to act as their own legal guardian

Exclusion Criteria:

* Age under 18

Primary outcomes:
measure: Percent attendance
timeFrame: During 6-week intervention period
measure: Participant satisfaction
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline, during 6-week intervention period
measure: Change in Aerobic Fitness from Baseline at 8 weeks
timeFrame: Baseline, 8 weeks
Other outcomes:
measure: Structured Assessment of FEeasibility
timeFrame: Approximately 1 year
Locations:
city: Augusta
country: United States
facility: Serenity Behavioral Health System
state: Georgia
city: Augusta
country: United States
facility: Georgia Prevention Institute
state: Georgia
Study officials:
affiliation: Augusta University
name: Catherine L Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kansas State University
name: Gina M Besenyi, MPH PhD
role: PRINCIPAL_INVESTIGATOR
References: