Physical Activity to Reduce Cardiometabolic Risk in Adults With Serious Mental Illness (PARCS) Study

NCT05457179 | Enrolling By Invitation DMC

• 1 other identifier: 11008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Mental Disorders, Severe; Mental Illness Persistent

Outcome Measures

Primary Outcomes (3)

• Feasibility - Attendance

  Feasibility will be assessed by attendance at park PA sessions. Higher attendance indicates greater engagement with the intervention

  Ongoing during the 12-week intervention period

• Acceptability - Change in PA Enjoyment

  Acceptability will be assessed via PA enjoyment captured using the Physical Activity Enjoyment Scale (PACES), an 18-item scale where participants rate feelings about PA on a 7-point Likert scale, from 1 (I enjoy it) to 7 (I hate it).

  post 12-week intervention

• Acceptability - PA session satisfaction

  Acceptability will also be assessed via PA session satisfaction measured using the abbreviated Physical Activity Class Satisfaction Questionnaire (PACSQ) which rates satisfaction of park-based class sessions on an 8-point Likert scale. 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.

  post 12-week intervention

Secondary Outcomes (6)

• Change in Self-efficacy for Exercise

  pre and post 12-week intervention

• Change in Self-efficacy and Intensions for Spending Time in Nature

  pre and post 12-week intervention

• Change in Exercise Goal Setting

  pre and post 12-week intervention

• Change in Support and Exercise

  pre and post 12-week intervention

• Physical Activity Participation

  Ongoing during the 12-week intervention period

Other Outcomes (6)

• Feasibility - Facility

  After completion of all waves of the study (approximately 2 years)

• Change in Body Composition

  pre and post 12-week intervention

• Change in Health-Related Quality of Life

  pre and post 12-week intervention

Study Arms (2)

Intervention

EXPERIMENTAL

PARCS is a park-based physical activity intervention including aerobic and resistance training adapted for adults with serious mental illness and led by certified peer counselors as part of peer group mental health recovery services.

Behavioral: Park-based physical activity

Active Control

ACTIVE COMPARATOR

The active control group will receive information about the importance of park-based PA and a map of local park locations but will not participate in structured park-based PA sessions. Participants in the control group will be invited to participate in park PA sessions after they have completed posttest. Participants in both groups will receive usual care outpatient peer group treatment services, including routine counseling and health and wellness information/activities given by CPSs.

Behavioral: Active Control

Interventions

Park-based physical activity BEHAVIORAL

The experimental arm will optimize a 12-week intervention 3 days/wk, last approximately 60 minutes, and consist of 10 minutes of warm up, 15 minutes of simple strength training activities, 25 minutes of moderate to vigorous aerobic activities (e.g., walking), and 10 minutes of cool down. The eight full-body strength training exercises will use body weight and/or elastic bands and will include a circuit of chest press, seated row, squat, shoulder press, biceps curl, triceps extension, calf raise, and reverse crunch. Sessions will include education and skill building activities focused on Social Cognitive Theory mechanisms of change including self-efficacy, goal setting, and social support. Under the guidance of trained research staff, certified peer specialists who have experience working with peer groups, will be selected to help deliver the intervention.

Intervention

Active Control BEHAVIORAL

The active control group will receive information about the importance of park-based PA and a map of local park locations but will not participate in structured park-based PA sessions. Participants in the control group will be invited to participate in park PA sessions after they have completed posttest.

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Authorized for peer group treatment through the behavioral health facility
• Medically cleared to participate in physical activity (if indicated by ACSM 11th Edition pre-exercise participation screener)

You may not qualify if:

• Under 18 years of age
• Unable to obtain physician clearance (if indicated by ACSM 11th Edition pre-exercise participation screener)

Sponsors & Collaborators

• Kansas State University: lead
• Augusta University: collaborator
• Dartmouth College: collaborator
• University of Cincinnati: collaborator

Study Sites (2)

Serenity Behavioral Health Systems

Augusta, Georgia, 30906, United States

Location

Pawnee Mental Health

Junction City, Kansas, 66441, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Gina M Besenyi, MPH, PhD

  Kansas State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-arm multi-site randomized clinical trial. The intervention arm will consist of peer counselor-led park-based physical activity sessions 3 days per week for 12 weeks incorporated into weekly peer counseling sessions. The active control arm will consist of physical activity and park information. Both arms will include standard of care peer-group counseling services.

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: July 13, 2022
• Study Start: August 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available to other interested researchers once major findings have been published or within two years of the project completion date, whichever is sooner.
• Access Criteria: To be determined

Locations

US (2)