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Completed

NCT Number: NCT05293587

Physical Activity to Reduce Diabetes Risk in Serious Mental Illness

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.

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Key information

Conditions

Mental Disorders, Severe Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Prevention Institute, Augusta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

  1. Change in Physical Activity

    Time frame: 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

    Time frame: Baseline, 8 weeks

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

Other outcomes

  1. Structured Assessment of FEeasibility

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PARCS Pilot

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2022
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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