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

Sponsor
Augusta University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05293587
Collaborator
Vanderbilt University School of Medicine (Other), Kansas State University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical Activity
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Waitlist control groupWaitlist control group
Masking:
Single (Outcomes Assessor)
Masking Description:
Fitbit data will be analyzed by Kansas State University personnel masked to group assignment.
Primary Purpose:
Prevention
Official Title:
Physical Activity to Reduce Diabetes Risk in Serious Mental Illness: PARCS Pilot Study
Actual Study Start Date :
Sep 13, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Percent attendance [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.

    2. Participant satisfaction [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 Outcome Measures

    1. Change in Physical Activity [Baseline, during 6-week intervention period]

      Fitbit min/week moderate to vigorous physical activity. Greater min/week physical activity is better.

    2. Change in Aerobic Fitness from Baseline at 8 weeks [Baseline, 8 weeks]

      6-minute walk test. Greater distance indicates better fitness.

    Other Outcome Measures

    1. Structured Assessment of FEeasibility [Approximately 1 year]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Serenity Behavioral Health System Augusta Georgia United States 30906
    2 Georgia Prevention Institute Augusta Georgia United States 30912

    Sponsors and Collaborators

    • Augusta University
    • Vanderbilt University School of Medicine
    • Kansas State University
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Catherine L Davis, PhD, Augusta University
    • Principal Investigator: Gina M Besenyi, MPH PhD, Kansas State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Catherine Davis, Professor of Medicine, Augusta University
    ClinicalTrials.gov Identifier:
    NCT05293587
    Other Study ID Numbers:
    • 1434186
    • 3P30DK020593-42S1
    • VUMC86160
    First Posted:
    Mar 24, 2022
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2022