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The Moms Online Video Exercise Study (MOVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805140
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Maya Mascarenhas, MPH, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Virtual exercise Behavioral: Mobile apps Behavioral: Exercise resources and information Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Moms Online Video Exercise Study
Study Start Date : August 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Virtual exercise
Using videoconferencing, mothers assigned to intervention arm will participate in daily (weekdays) virtual exercise sessions for 6 weeks with other mothers.

Behavioral: Mobile apps
During virtual exercise sessions, mothers assigned to intervention arm will follow exercise routines using mobile exercise apps that are recommended by study staff.

Behavioral: Exercise resources and information
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.

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.
Behavioral: Exercise resources and information
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.




Primary Outcome Measures :
  1. Feasibility of recruitment [ Time Frame: End of 8 week recruitment period ]
    Recruiting 75% of goal of 38 participants

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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

  2. Change in exercise enjoyment [ Time Frame: 0 weeks, 8 weeks ]
    Using Sallis Short Form 3 item exercise enjoyment scale, the investigators will measure changes in exercise enjoyment

  3. Change in exercise social support [ Time Frame: 0 weeks, 8 weeks ]
    Using Sallis Short Form 3 item exercise social support scale, the investigators will measure changes in exercise social support

  4. Change in global health [ Time Frame: 0 weeks, 8 weeks ]
    Using NIH Patient Reported Outcome Measurement System (PROMIS) Global Health 7 item measure, the investigators will measure overall changes in global health

  5. Change in fatigue [ Time Frame: 0 weeks, 8 weeks ]
    Using NIH Patient Reported Outcome Measurement System (PROMIS) Global Health 4 item measure, the investigators will measure overall changes in fatigue

  6. Change in weight [ Time Frame: 0 weeks, 8 weeks ]
    Difference in pounds gained or lost in lbs measured by self report via survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805140


Locations
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United States, California
UCSF
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maya Mascarenhas, MPH, Doctoral Student, Epidemiology & Biostatistics, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02805140    
Other Study ID Numbers: 14-15344
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maya Mascarenhas, MPH, University of California, San Francisco:
mother
social support
mobile app
videoconference
sedentary
physical activity