NCT05247242

Brief Summary

Using a community-based participatory approach, this project aims to evaluate the feasibility, acceptability, and preliminary efficacy of two technology-driven group activity programs on socioemotional health and physical activity in a local underserved community, Tarrant, Alabama. Participants will complete two six-week programs, specifically Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 19, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

January 18, 2022

Last Update Submit

January 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Social Isolation from Baseline to 12 weeks

    PROMIS Item Bank v2.0 - Social Isolation - SF 8a

    12 Weeks

Secondary Outcomes (7)

  • Change in Self-efficacy from Baseline to 12 weeks

    12 Weeks

  • Change in Loneliness from Baseline to 12 weeks

    12 Weeks

  • Change in Positive Affect from Baseline to 12 weeks

    12 Weeks

  • Change in Health-related quality of life from Baseline to 12 weeks

    12 Weeks

  • Change in Physical activity from Baseline to 12 weeks

    12 Weeks

  • +2 more secondary outcomes

Study Arms (2)

Tarrant Community Fitness Program: LOF-VR

EXPERIMENTAL

LOF-VR

Behavioral: Lakeshore Online Fitness (Online)Behavioral: Get Active with Virtual Reality (VR)

Tarrant Community Fitness Program: VR-LOF

EXPERIMENTAL

VR-LOF

Behavioral: Lakeshore Online Fitness (Online)Behavioral: Get Active with Virtual Reality (VR)

Interventions

Online physical activity program delivered to residents of Tarrant, AL via teleconferencing technology to a local community center. Instructors from Lakeshore will lead the physical activity program. This intervention will last six weeks.

Tarrant Community Fitness Program: LOF-VRTarrant Community Fitness Program: VR-LOF

Participants will utilize the Oculus Quest 2 virtual reality headset, which is a head-mounted display system where users can interact with a virtual environment in a gaming setting. The Oculus Quest 2 incorporates social features where participants can interact with other users. This VR intervention will include periods of gameplay where participants can play games in either competitive or cooperative settings. This intervention will last six weeks.

Tarrant Community Fitness Program: LOF-VRTarrant Community Fitness Program: VR-LOF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resident of Tarrant, Alabama
  • years or older with a physical disability or chronic health condition or older than 60 years
  • Fluent in English

You may not qualify if:

  • Visual impairment that interferes with television viewing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarrant Parks and Recreation

Tarrant, Alabama, 35217, United States

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher IV

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 18, 2022

Study Start

July 19, 2022

Primary Completion

December 27, 2023

Study Completion

December 27, 2023

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations