Physical Activity to Reduce Diabetes Risk in Serious Mental Illness

NCT ID: NCT05293587

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Mental Disorders, Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Waitlist control group
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Fitbit data will be analyzed by Kansas State University personnel masked to group assignment.

Study Groups

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Physical Activity

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

Group Type EXPERIMENTAL

Physical Activity

Intervention Type 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.

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Park-based Physical Activity

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University School of Medicine

OTHER

Sponsor Role collaborator

Kansas State University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Catherine Davis

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine L Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Gina M Besenyi, MPH PhD

Role: PRINCIPAL_INVESTIGATOR

Kansas State University

Locations

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Serenity Behavioral Health System

Augusta, Georgia, United States

Site Status

Georgia Prevention Institute

Augusta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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3P30DK020593-42S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VUMC86160

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1434186

Identifier Type: -

Identifier Source: org_study_id

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