Sedentary LifestyleMOVENCT02805140
The Moms Online Video Exercise Study
A study testing Virtual exercise, Mobile apps and Exercise resources and information in people with Sedentary Lifestyle, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to test feasibility and acceptability of an online platform that uses mobile apps and videoconferencing tools to increase activity levels in mothers with young children. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Virtual exercise, Mobile apps and Exercise resources and information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Feb 2017
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mother to at least one child that is less than 18 years old
- Owns a smart phone (iPhone or Android) and can download mobile applications
- Sufficient data to use mobile applications on a mobile device
- Owns a mobile device with a web camera
Who cannot join
- Inability to provide informed consent
- Inability to speak or understand English
- Any medical restrictions where vigorous activity is not recommended
- Any history of heart conditions including cardiovascular disease or coronary artery disease
- Any history of heart conditions including cardiovascular disease or coronary artery disease
- Meets federal guidelines for exercise for either aerobic (150 minutes of moderate activity per week, 75 minutes of vigorous activity per week, or some combination)
- Pregnant or planning to get pregnant during study duration
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test feasibility and acceptability of an online platform that uses mobile apps and videoconferencing tools to increase activity levels in mothers with young children.
Read the detailed description
The investigators are testing the feasibility and acceptability of a digital health platform using a randomized parallel wait-list control design for mothers with young children. The platform incorporates home based supportive group exercise sessions using video conferencing tools, shared online activity tracking and exercise mobile apps for individualized exercise routines will help mothers increase their physical activity levels and be successful at maintaining this increase.
The intervention arm consists of two main parts: home based video conferencing virtual exercise sessions and mobile exercise apps, which women use to tailor exercise routines to their own skill level and preferences. Both arms will receive an activity monitor that they collect continuous activity data throughout the study.
- Conditions
- Sedentary Lifestyle
- Being tested
- Virtual exercise, Mobile apps, Exercise resources and information
- Keywords
- mother, social support, mobile app, videoconference, sedentary, physical activity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual exerciseBehavioural
Using videoconferencing, mothers assigned to intervention arm will participate in daily (weekdays) virtual exercise sessions for 6 weeks with other mothers.
Mobile appsBehavioural
During virtual exercise sessions, mothers assigned to intervention arm will follow exercise routines using mobile exercise apps that are recommended by study staff.
Exercise resources and informationBehavioural
For all mothers, the investigators will provide standard information on the benefits of exercise and link to existing public health resources on how to start and stay active.
| Study group | Role | What they receive |
|---|---|---|
| Virtual exercise and mobile apps | Experimental | Participants randomized to the intervention arm will join a virtual group convenient for them. They will plan and participate in 8 weeks (every week day) of virtual exercise sessions. Sessions will all be under 30 minutes and include a brief check in amongst participants. The investigators will provide links to information on physical activity and links to online resources for being active. Receives: Behavioral: Virtual exercise; Behavioral: Mobile apps; Behavioral: Exercise resources and information |
| Exercise resources and information | Active comparator | The investigators will provide links to information on physical activity and links to online resources for being active. Women will be invited to join the exercise groups at the end of the 8 weeks. Receives: Behavioral: Exercise resources and information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Recruiting 75% of goal of 38 participants
Measured: End of 8 week recruitment period
Acceptability of study procedures
We will consider at least 75% of participants being "satisfied" or "very satisfied" (using a Likert scale) in the overall study evaluation to indicate acceptability of the study materials.
Measured: End of 8 week intervention period
Change in minutes per week of moderate-to-vigorous physical activity
Active minutes (past 7 days) using self report through Active Australia Survey
Measured: 0 weeks, 8 weeks
Secondary outcomes (6)
Change in exercise self efficacy
Using Sallis Short Form 3 item self efficacy scale, the investigators will measure changes in exercise self efficacy
Measured: 0 weeks, 8 weeks
Change in exercise enjoyment
Using Sallis Short Form 3 item exercise enjoyment scale, the investigators will measure changes in exercise enjoyment
Measured: 0 weeks, 8 weeks
Change in exercise social support
Using Sallis Short Form 3 item exercise social support scale, the investigators will measure changes in exercise social support
Measured: 0 weeks, 8 weeks
Change in global health
Using NIH Patient Reported Outcome Measurement System (PROMIS) Global Health 7 item measure, the investigators will measure overall changes in global health
Measured: 0 weeks, 8 weeks
Change in fatigue
Using NIH Patient Reported Outcome Measurement System (PROMIS) Global Health 4 item measure, the investigators will measure overall changes in fatigue
Measured: 0 weeks, 8 weeks
Change in weight
Difference in pounds gained or lost in lbs measured by self report via survey
Measured: 0 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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 Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Mascarenhas, MPH, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805140
- Sponsor's protocol ID
- 14-15344
- Acronym
- MOVE
- Status last verified
- Nov 2017
- First submitted
- 28 Mar 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mascarenhas MN, Chan JM, Vittinghoff E, Van Blarigan EL, Hecht F. Increasing Physical Activity in Mothers Using Video Exercise Groups and Exercise Mobile Apps: Randomized Controlled Trial. J Med Internet Res. 2018 May 18;20(5):e179. doi: 10.2196/jmir.9310.
PubMed 29776899
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Moms Online Video Exercise Study
- ClinicalTrials.gov ID
- NCT02805140
- Acronym / sponsor ID
- MOVE / 14-15344
- Conditions
- Sedentary Lifestyle
- Keywords
- mother, social support, mobile app, videoconference, sedentary, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
The purpose of this study is to test feasibility and acceptability of an online platform that uses mobile apps and videoconferencing tools to increase activity levels in mothers with young children.
Detailed description
The investigators are testing the feasibility and acceptability of a digital health platform using a randomized parallel wait-list control design for mothers with young children. The platform incorporates home based supportive group exercise sessions using video conferencing tools, shared online activity tracking and exercise mobile apps for individualized exercise routines will help mothers increase their physical activity levels and be successful at maintaining this increase.
The intervention arm consists of two main parts: home based video conferencing virtual exercise sessions and mobile exercise apps, which women use to tailor exercise routines to their own skill level and preferences. Both arms will receive an activity monitor that they collect continuous activity data throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual exercise and mobile apps | Experimental | Behavioral: Virtual exercise, Behavioral: Mobile apps, Behavioral: Exercise resources and informationParticipants randomized to the intervention arm will join a virtual group convenient for them. They will plan and participate in 8 weeks (every week day) of virtual exercise sessions. Sessions will all be under 30 minutes and include a brief check in amongst participants. The investigators will provide links to information on physical activity and links to online resources for being active. |
| Exercise resources and information | Active comparator | Behavioral: Exercise resources and informationThe investigators will provide links to information on physical activity and links to online resources for being active. Women will be invited to join the exercise groups at the end of the 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mother to at least one child that is less than 18 years old
- Owns a smart phone (iPhone or Android) and can download mobile applications
- Sufficient data to use mobile applications on a mobile device
- Owns a mobile device with a web camera
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Inability to speak or understand English
- Any medical restrictions where vigorous activity is not recommended
- Any history of heart conditions including cardiovascular disease or coronary artery disease
- Any history of heart conditions including cardiovascular disease or coronary artery disease
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 |
|---|---|---|
| Virtual exerciseUsing videoconferencing, mothers assigned to intervention arm will participate in daily (weekdays) virtual exercise sessions for 6 weeks with other mothers. | Behavioural | Virtual exercise and mobile apps |
| Mobile appsDuring virtual exercise sessions, mothers assigned to intervention arm will follow exercise routines using mobile exercise apps that are recommended by study staff. | Behavioural | Virtual exercise and mobile apps |
| Exercise resources and informationFor all mothers, the investigators will provide standard information on the benefits of exercise and link to existing public health resources on how to start and stay active. | Behavioural | Exercise resources and information, Virtual exercise and mobile apps |
Primary outcome
Feasibility of recruitment
Time frame: End of 8 week recruitment period
Recruiting 75% of goal of 38 participants
Acceptability of study procedures
Time frame: End of 8 week intervention period
We will consider at least 75% of participants being "satisfied" or "very satisfied" (using a Likert scale) in the overall study evaluation to indicate acceptability of the study materials.
Change in minutes per week of moderate-to-vigorous physical activity
Time frame: 0 weeks, 8 weeks
Active minutes (past 7 days) using self report through Active Australia Survey
6 secondary outcomes
Change in exercise self efficacy
Time frame: 0 weeks, 8 weeks
Change in exercise enjoyment
Time frame: 0 weeks, 8 weeks
Change in exercise social support
Time frame: 0 weeks, 8 weeks
Change in global health
Time frame: 0 weeks, 8 weeks
Change in fatigue
Time frame: 0 weeks, 8 weeks
Change in weight
Time frame: 0 weeks, 8 weeks
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 17 Nov 2017.
- Derived from this study: PubMed 29776899Mascarenhas MN, Chan JM, Vittinghoff E, Van Blarigan EL, Hecht F. Increasing Physical Activity in Mothers Using Video Exercise Groups and Exercise Mobile Apps: Randomized Controlled Trial. J Med Internet Res. 2018 May 18;20(5):e179. doi: 10.2196/jmir.9310.
- 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 Virtual exercise, Mobile apps and Exercise resources and information in people with Sedentary Lifestyle, run by University of California, San Francisco 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 4 inclusion and 7 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 17 Nov 2017. 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?
Feasibility of recruitment (time frame: End of 8 week recruitment period). 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 NCT02805140, 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 17 Nov 2017.