NCT05293587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

August 18, 2021

Last Update Submit

January 30, 2023

Conditions

Mental Disorders, Severe

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in Physical Activity

    Baseline, during 6-week intervention period

  • Change in Aerobic Fitness from Baseline at 8 weeks

    Baseline, 8 weeks

Other Outcomes (1)

  • Structured Assessment of FEeasibility

    Approximately 1 year

Study Arms (2)

Physical Activity

EXPERIMENTAL

Physical activity sessions at public parks led by a Serenity Behavioral Health Certified Peer Specialist

Behavioral: Physical Activity

Waitlist

NO INTERVENTION

Participants will continue their usual care in the PEERS program. They will be offered the intervention after they have completed posttest measures.

Interventions

Physical ActivityBEHAVIORAL

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.

Also known as: Park-based Physical Activity
Physical Activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Serenity Behavioral Health System

Augusta, Georgia, 30906, United States

Location

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Catherine L Davis, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

  • Gina M Besenyi, MPH PhD

    Kansas State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Fitbit data will be analyzed by Kansas State University personnel masked to group assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Waitlist control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 18, 2021

First Posted

March 24, 2022

Study Start

September 13, 2021

Primary Completion

August 26, 2022

Study Completion

August 31, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Deidentified data will be shared with colleagues who have a reasonable request and analysis plan with appropriate credit.

Shared Documents
STUDY PROTOCOL, ICF

Locations

US(2)