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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02805140
Other study ID # 14-15344
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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