An mHealth Exercise Intervention for Sedentary Adults

A Remotely Delivered, Web-Based Exercise Intervention for Sedentary Adults: Randomized Controlled Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Exercise Behavior
• Intervention / Treatment: Behavioral: Wellness Education; Behavioral: Exercise Videos; Behavioral: Livestream Classes

Detailed Description

Primary Objective To determine the feasibility and acceptability of an 8-week remotely-delivered exercise intervention by conducting a randomized controlled study comparing 3 levels of behavioral engagement.

Secondary Objectives

To compare the effectiveness of 3 levels of web-based interaction on physical activity behavior, physiological training dose, motivation and quality of life. Participants are randomly assigned to 1 of 3 groups:

Level 1 (attention control): Participants receive health educational materials through email and the web portal.

Level 2 (videos): Participants receive health education materials + access to 24 pre-recorded exercise videos.

Level 3 (livestream classes): Participant receive health education materials + livestream exercise classes 3 days/week for 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90840
      • California State University, Long Beach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Level 1; Wellness Education	Behavioral: Wellness Education; Receive wellness education through a weekly email and web portal content.
Experimental: Level 2; Wellness Education + Pre-recorded Exercise Videos	Behavioral: Wellness Education; Receive wellness education through a weekly email and web portal content.; Behavioral: Exercise Videos; Receive pre-recorded exercise videos through a weekly email and web portal content.
Experimental: Level 3; Wellness Education + Livestream Exercise Classes	Behavioral: Wellness Education; Receive wellness education through a weekly email and web portal content.; Behavioral: Livestream Classes; Receive 3 videoconference group exercise classes per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate to Vigorous Physical Activity	Amount of time per week spent performing activity >63% maximum heart rate	Up to 2 months
Resting Heart Rate	Average heart rate over a 10 minute period taken while sitting at rest	Baseline, 2 months
International Physical Activity Questionnaire (IPAQ)	IPAQ estimates weekly moderate to vigorous intensity physical activity	Baseline, 2 months
Short Form-36 (SF-36)	A 36-item survey that assesses general quality of life status	Baseline, 2 months
Profile of Mood States (POMS)	A 65-item survey that assesses the participant's mood	Baseline, 2 months
Physical Activity Group Questionnaire	A 21-item survey that assesses individual and group perceptions of task and social cohesion	Baseline, 2 months

Collaborators and Investigators

• Sponsor: California State University, Long Beach

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20-240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No