- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02805140
The Moms Online Video Exercise Study (MOVE)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94110
- UCSF
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Virtual exercise and mobile apps
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.
|
Using videoconferencing, mothers assigned to intervention arm will participate in daily (weekdays) virtual exercise sessions for 6 weeks with other mothers.
During virtual exercise sessions, mothers assigned to intervention arm will follow exercise routines using mobile exercise apps that are recommended by study staff.
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.
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|
Active Comparator: Exercise resources and information
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of recruitment
Time Frame: End of 8 week recruitment period
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Recruiting 75% of goal of 38 participants
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End of 8 week recruitment period
|
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Acceptability of study procedures
Time Frame: End of 8 week intervention period
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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.
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End of 8 week intervention period
|
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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
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0 weeks, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in exercise self efficacy
Time Frame: 0 weeks, 8 weeks
|
Using Sallis Short Form 3 item self efficacy scale, the investigators will measure changes in exercise self efficacy
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0 weeks, 8 weeks
|
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Change in exercise enjoyment
Time Frame: 0 weeks, 8 weeks
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Using Sallis Short Form 3 item exercise enjoyment scale, the investigators will measure changes in exercise enjoyment
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0 weeks, 8 weeks
|
|
Change in exercise social support
Time Frame: 0 weeks, 8 weeks
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Using Sallis Short Form 3 item exercise social support scale, the investigators will measure changes in exercise social support
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0 weeks, 8 weeks
|
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Change in global health
Time Frame: 0 weeks, 8 weeks
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Using NIH Patient Reported Outcome Measurement System (PROMIS) Global Health 7 item measure, the investigators will measure overall changes in global health
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0 weeks, 8 weeks
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Change in fatigue
Time Frame: 0 weeks, 8 weeks
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Using NIH Patient Reported Outcome Measurement System (PROMIS) Global Health 4 item measure, the investigators will measure overall changes in fatigue
|
0 weeks, 8 weeks
|
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Change in weight
Time Frame: 0 weeks, 8 weeks
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Difference in pounds gained or lost in lbs measured by self report via survey
|
0 weeks, 8 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14-15344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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