Physical Activity to Reduce Diabetes Risk in Serious Mental Illness

Mental Disorders, Severe Clinical Trial

— PARCS Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05293587
• Other study ID #: 1434186
• Secondary ID: 3P30DK020593-42S
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2023
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Disorders, Severe

Intervention

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.

Locations

Country	Name	City	State
United States	Georgia Prevention Institute	Augusta	Georgia
United States	Serenity Behavioral Health System	Augusta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Augusta University	Kansas State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Vanderbilt University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Structured Assessment of FEeasibility	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).	Approximately 1 year
Primary	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
Primary	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 a's = .85), and survey items are highly correlated with participants' intentions to attend a similar course in the future.	8 weeks
Secondary	Change in Physical Activity	Fitbit min/week moderate to vigorous physical activity. Greater min/week physical activity is better.	Baseline, during 6-week intervention period
Secondary	Change in Aerobic Fitness from Baseline at 8 weeks	6-minute walk test. Greater distance indicates better fitness.	Baseline, 8 weeks