NCT05192421

Brief Summary

This pilot trial examines the feasibility and acceptability of a web-based, social networking exercise intervention in improving physical activity behavior in adults who do not perform regular exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 7, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

January 5, 2022

Last Update Submit

September 3, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Accrual

    Measured as the percentage of the eligible target sample enrolled within a 1-year recruitment period.

    Up to 1 year

  • Retention

    Measured as the percentage of participants completing post-intervention assessments

    Up to 1 month

  • Adherence

    Measured as the number sessions completed using activity tracker

    Up to 2 months

Secondary Outcomes (6)

  • Moderate to Vigorous Physical Activity

    Up to 2 months

  • Resting Heart Rate

    Baseline, 2 months

  • International Physical Activity Questionnaire (IPAQ)

    Baseline, 2 months

  • Short Form-36 (SF-36)

    Baseline, 2 months

  • Profile of Mood States (POMS)

    Baseline, 2 months

  • +1 more secondary outcomes

Study Arms (3)

Level 1

ACTIVE COMPARATOR

Wellness Education

Behavioral: Wellness Education

Level 2

EXPERIMENTAL

Wellness Education + Pre-recorded Exercise Videos

Behavioral: Wellness EducationBehavioral: Exercise Videos

Level 3

EXPERIMENTAL

Wellness Education + Livestream Exercise Classes

Behavioral: Wellness EducationBehavioral: Livestream Classes

Interventions

Receive wellness education through a weekly email and web portal content.

Level 1Level 2Level 3
Exercise VideosBEHAVIORAL

Receive pre-recorded exercise videos through a weekly email and web portal content.

Level 2

Receive 3 videoconference group exercise classes per week for 8 weeks.

Level 3

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not exceeding 60 total minutes of physical activity per week
  • Access to computer or mobile device with high speed internet connection

You may not qualify if:

  • History of myocardial infarction, angioplasty, coronary artery bypass, cerebrovascular ischemia/stroke, symptomatic congestive heart failure, atrial flutter, unstable angina, or unstable pulmonary disease; pacemaker; history of alcoholism, drug abuse or other psychiatric problems; current use of tricyclic antidepressant or clozapine medications; type 1 diabetes; orthopedic or rheumatologic problems that could impair the ability to walk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California State University, Long Beach

Long Beach, California, 90840, United States

Location

Related Publications (1)

  • Dawson JK, Ede A, Phan M, Sequeira A, Teng HL, Donlin A. Feasibility and Acceptability of a Mobile Health Exercise Intervention for Inactive Adults: 3-Arm Randomized Controlled Pilot Trial. JMIR Form Res. 2024 Aug 9;8:e52428. doi: 10.2196/52428.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 14, 2022

Study Start

July 7, 2020

Primary Completion

January 31, 2022

Study Completion

June 30, 2022

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations