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

Primary Purpose

Mental Disorders, Severe

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Disorders, Severe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Serenity Behavioral Health System
  • Georgia Prevention Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Activity

Waitlist

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Physical Activity
Fitbit min/week moderate to vigorous physical activity. Greater min/week physical activity is better.
Change in Aerobic Fitness from Baseline at 8 weeks
6-minute walk test. Greater distance indicates better fitness.

Full Information

First Posted
August 18, 2021
Last Updated
January 30, 2023
Sponsor
Augusta University
Collaborators
Vanderbilt University School of Medicine, Kansas State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05293587
Brief Title
Physical Activity to Reduce Diabetes Risk in Serious Mental Illness
Acronym
PARCS Pilot
Official Title
Physical Activity to Reduce Diabetes Risk in Serious Mental Illness: PARCS Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
August 26, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
Collaborators
Vanderbilt University School of Medicine, Kansas State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Severe

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Waitlist control group
Masking
Outcomes Assessor
Masking Description
Fitbit data will be analyzed by Kansas State University personnel masked to group assignment.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity
Arm Type
Experimental
Arm Description
Physical activity sessions at public parks led by a Serenity Behavioral Health Certified Peer Specialist
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants will continue their usual care in the PEERS program. They will be offered the intervention after they have completed posttest measures.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Other Intervention Name(s)
Park-based Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent attendance
Description
Feasibility will be assessed by attendance to park PA sessions (0-100%). Higher attendance indicates greater engagement with the intervention.
Time Frame
During 6-week intervention period
Title
Participant satisfaction
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Physical Activity
Description
Fitbit min/week moderate to vigorous physical activity. Greater min/week physical activity is better.
Time Frame
Baseline, during 6-week intervention period
Title
Change in Aerobic Fitness from Baseline at 8 weeks
Description
6-minute walk test. Greater distance indicates better fitness.
Time Frame
Baseline, 8 weeks
Other Pre-specified Outcome Measures:
Title
Structured Assessment of FEeasibility
Description
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).
Time Frame
Approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine L Davis, PhD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gina M Besenyi, MPH PhD
Organizational Affiliation
Kansas State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Serenity Behavioral Health System
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30906
Country
United States
Facility Name
Georgia Prevention Institute
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be shared with colleagues who have a reasonable request and analysis plan with appropriate credit.

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Physical Activity to Reduce Diabetes Risk in Serious Mental Illness

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