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Clinical Trials/NCT05293587
NCT05293587
Completed
Not Applicable

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

Augusta University2 sites in 1 country20 target enrollmentSeptember 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Disorders, Severe
Sponsor
Augusta University
Enrollment
20
Locations
2
Primary Endpoint
Percent attendance
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 13, 2021
End Date
August 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine Davis

Professor of Medicine

Augusta University

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

Outcomes

Primary Outcomes

Percent attendance

Time Frame: During 6-week intervention period

Feasibility will be assessed by attendance to park PA sessions (0-100%). Higher attendance indicates greater engagement with the intervention.

Participant satisfaction

Time Frame: 8 weeks

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.

Secondary Outcomes

  • Change in Aerobic Fitness from Baseline at 8 weeks(Baseline, 8 weeks)
  • Change in Physical Activity(Baseline, during 6-week intervention period)

Study Sites (2)

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