Physical Activity to Reduce Diabetes Risk in Serious Mental Illness (PARCS Pilot)

Physical Activity to Reduce Diabetes Risk in Serious Mental Illness: PARCS Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders, Severe
• Intervention / Treatment: Behavioral: Physical Activity

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Prevention Institute
    • Augusta, Georgia, United States, 30906
      • Serenity Behavioral Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity; Physical activity sessions at public parks led by a Serenity Behavioral Health Certified Peer Specialist	Behavioral: Physical Activity; Physical activity sessions will take place 3x/week over six weeks and will take between 45 and 60 minutes for each session. The sessions will be led by a Serenity Behavioral Health CPS as part of the PEERS program and will be supervised by research staff. Sessions will occur at public parks. Transportation to the park will be provided by Serenity Behavioral Health. Structured activities will include a warm-up, a mix of simple exercises requiring minimal supplies (such as walking, basic aerobic movements, and body weight resistance exercises), and cool-down. Sessions will be held in green park environments with shade, restrooms, and level walking paths.; Other Names: Park-based Physical Activity
No Intervention: Waitlist; Participants will continue their usual care in the PEERS program. They will be offered the intervention after they have completed posttest measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent attendance	Feasibility will be assessed by attendance to park PA sessions (0-100%). Higher attendance indicates greater engagement with the intervention.	During 6-week intervention period
Participant satisfaction	Acceptability will be assessed via participant satisfaction, measured using an abbreviated version of the Physical Activity Class Satisfaction Questionnaire (PACSQ). PACSQ is a valid measure for capturing client satisfaction within exercise classes in the following nine dimensions: mastery experiences, cognitive development, teaching, normative success, interaction with others, fun and enjoyment, improvement of health and fitness, diversionary experiences, and relaxation. Each of the dimensions of satisfaction is measured using an 8-point Likert scale, with responses ranging from 1="No satisfaction" to 8="Very satisfying". PACSQ has shown acceptable reliability in each of its subscales (all α's ≥ .85), and survey items are highly correlated with participants' intentions to attend a similar course in the future.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity	Fitbit min/week moderate to vigorous physical activity. Greater min/week physical activity is better.	Baseline, during 6-week intervention period
Change in Aerobic Fitness from Baseline at 8 weeks	6-minute walk test. Greater distance indicates better fitness.	Baseline, 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structured Assessment of FEeasibility	The Structured Assessment of FEeasibility (SAFE) standardized measure will be used to determine overall intervention feasibility. The SAFE measure specifically evaluates interventions within a mental health services framework and includes 16 items that capture information in three categories: intervention, resource consequences, and evaluation. The PI in collaboration with CPSs will complete the SAFE measure. The SAFE measure has demonstrated excellent inter-rater and test-retest reliability (0.84, 95% confidence interval (CI) 0.79-0.89; 0.89, 95% CI 0.85-0.93 respectively). Rather than using a summary score, the individual items should be considered (e.g., yes, partial, no, unable to rate).	Approximately 1 year

Collaborators and Investigators

• Sponsor: Augusta University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Kansas State University; Vanderbilt University School of Medicine
• Investigators: Principal Investigator: Catherine L Davis, PhD, Augusta University; Principal Investigator: Gina M Besenyi, MPH PhD, Kansas State University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): August 26, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: March 19, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 1434186; 3P30DK020593-42S1 (U.S. NIH Grant/Contract); VUMC86160 (Other Grant/Funding Number: Vanderbilt Diabetes Res. & Trng Ctr Pilot/Feasibility Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be shared with colleagues who have a reasonable request and analysis plan with appropriate credit.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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