Physical Activity to Reduce Diabetes Risk in Serious Mental Illness

Not Applicable

Completed

• Conditions: Mental Disorders, Severe
• Interventions: Behavioral: Physical Activity

• Registration Number: NCT05293587
• Lead Sponsor: Augusta University

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.

Study Timeline

• Study First Submitted: 2021-08-18
• Study Start: 2021-09-13
• Study First Submitted QC: 2022-03-19
• Study First Posted: 2022-03-24
• Primary Completion: 2022-08-26
• Study Completion: 2022-08-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity	Physical Activity	Physical activity sessions at public parks led by a Serenity Behavioral Health Certified Peer Specialist

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
Change in Aerobic Fitness from Baseline at 8 weeks	Baseline, 8 weeks	6-minute walk test. Greater distance indicates better fitness.
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.

Trial Locations

Locations (2)

Georgia Prevention Institute; 🇺🇸 Augusta, Georgia, United States

Serenity Behavioral Health System; 🇺🇸 Augusta, Georgia, United States