The Moms Online Video Exercise Study

Sedentary Lifestyle Clinical Trial

— MOVE  

Official title:

The Moms Online Video Exercise Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805140
• Other study ID #: 14-15344
• Status: Completed
• Phase: N/A
• First received: March 28, 2016
• Last updated: November 14, 2017
• Start date: August 2016
• Est. completion date: February 2017

Study information

• Verified date: November 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

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

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	Recruiting 75% of goal of 38 participants	End of 8 week recruitment period
Primary	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.	End of 8 week intervention period
Primary	Change in minutes per week of moderate-to-vigorous physical activity	Active minutes (past 7 days) using self report through Active Australia Survey	0 weeks, 8 weeks
Secondary	Change in exercise self efficacy	Using Sallis Short Form 3 item self efficacy scale, the investigators will measure changes in exercise self efficacy	0 weeks, 8 weeks
Secondary	Change in exercise enjoyment	Using Sallis Short Form 3 item exercise enjoyment scale, the investigators will measure changes in exercise enjoyment	0 weeks, 8 weeks
Secondary	Change in exercise social support	Using Sallis Short Form 3 item exercise social support scale, the investigators will measure changes in exercise social support	0 weeks, 8 weeks
Secondary	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	0 weeks, 8 weeks
Secondary	Change in fatigue	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
Secondary	Change in weight	Difference in pounds gained or lost in lbs measured by self report via survey	0 weeks, 8 weeks