Exercise BehaviorNCT05192421
An mHealth Exercise Intervention for Sedentary Adults
A study testing Wellness Education, Exercise Videos and Livestream Classes in people with Exercise Behavior, run by California State University, Long Beach at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Behavior
- What is being tested?
- Wellness Education, Exercise Videos and Livestream Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not exceeding 60 total minutes of physical activity per week
- Access to computer or mobile device with high speed internet connection
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
California State University, Long Beach
Long Beach, California, 90840
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise Behavior
- Being tested
- Wellness Education, Exercise Videos, Livestream Classes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness EducationBehavioural
Receive wellness education through a weekly email and web portal content.
Exercise VideosBehavioural
Receive pre-recorded exercise videos through a weekly email and web portal content.
Livestream ClassesBehavioural
Receive 3 videoconference group exercise classes per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Level 1 | Active comparator | Wellness Education Receives: Behavioral: Wellness Education |
| Level 2 | Experimental | Wellness Education + Pre-recorded Exercise Videos Receives: Behavioral: Wellness Education; Behavioral: Exercise Videos |
| Level 3 | Experimental | Wellness Education + Livestream Exercise Classes Receives: Behavioral: Wellness Education; Behavioral: Livestream Classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual
Measured as the percentage of the eligible target sample enrolled within a 1-year recruitment period.
Measured: Up to 1 year
Retention
Measured as the percentage of participants completing post-intervention assessments
Measured: Up to 1 month
Adherence
Measured as the number sessions completed using activity tracker
Measured: Up to 2 months
Secondary outcomes (6)
Moderate to Vigorous Physical Activity
Amount of time per week spent performing activity >63% maximum heart rate
Measured: Up to 2 months
Resting Heart Rate
Average heart rate over a 10 minute period taken while sitting at rest
Measured: Baseline, 2 months
International Physical Activity Questionnaire (IPAQ)
IPAQ estimates weekly moderate to vigorous intensity physical activity
Measured: Baseline, 2 months
Short Form-36 (SF-36)
A 36-item survey that assesses general quality of life status
Measured: Baseline, 2 months
Profile of Mood States (POMS)
A 65-item survey that assesses the participant's mood
Measured: Baseline, 2 months
Physical Activity Group Questionnaire
A 21-item survey that assesses individual and group perceptions of task and social cohesion
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start7 Jul 2020
- Primary completion31 Jan 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Long Beach
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jackie Kiwata Dawson, PhD, California State University, Long Beach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192421
- Sponsor's protocol ID
- 20-240
- Status last verified
- Sep 2023
- First submitted
- 5 Jan 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39120078
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remotely Delivered, Web-Based Exercise Intervention for Sedentary Adults: Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05192421
- Acronym / sponsor ID
- 20-240
- Conditions
- Exercise Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- California State University, Long BeachUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Level 1 | Active comparator | Behavioral: Wellness EducationWellness Education |
| Level 2 | Experimental | Behavioral: Wellness Education, Behavioral: Exercise VideosWellness Education + Pre-recorded Exercise Videos |
| Level 3 | Experimental | Behavioral: Wellness Education, Behavioral: Livestream ClassesWellness Education + Livestream Exercise Classes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Not exceeding 60 total minutes of physical activity per week
- Access to computer or mobile device with high speed internet connection
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness EducationReceive wellness education through a weekly email and web portal content. | Behavioural | Level 1, Level 2, Level 3 |
| Exercise VideosReceive pre-recorded exercise videos through a weekly email and web portal content. | Behavioural | Level 2 |
| Livestream ClassesReceive 3 videoconference group exercise classes per week for 8 weeks. | Behavioural | Level 3 |
Primary outcome
Accrual
Time frame: Up to 1 year
Measured as the percentage of the eligible target sample enrolled within a 1-year recruitment period.
Retention
Time frame: Up to 1 month
Measured as the percentage of participants completing post-intervention assessments
Adherence
Time frame: Up to 2 months
Measured as the number sessions completed using activity tracker
6 secondary outcomes
Moderate to Vigorous Physical Activity
Time frame: Up to 2 months
Resting Heart Rate
Time frame: Baseline, 2 months
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 2 months
Short Form-36 (SF-36)
Time frame: Baseline, 2 months
Profile of Mood States (POMS)
Time frame: Baseline, 2 months
Physical Activity Group Questionnaire
Time frame: Baseline, 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 39120078Dawson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Education, Exercise Videos and Livestream Classes in people with Exercise Behavior, run by California State University, Long Beach at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.