NCT02805140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

March 28, 2016

Last Update Submit

November 14, 2017

Conditions

Keywords

mothersocial supportmobile appvideoconferencesedentaryphysical activity

Outcome Measures

Primary Outcomes (3)

  • Feasibility of recruitment

    Recruiting 75% of goal of 38 participants

    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.

    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

    0 weeks, 8 weeks

Secondary Outcomes (6)

  • Change in exercise self efficacy

    0 weeks, 8 weeks

  • Change in exercise enjoyment

    0 weeks, 8 weeks

  • Change in exercise social support

    0 weeks, 8 weeks

  • Change in global health

    0 weeks, 8 weeks

  • Change in fatigue

    0 weeks, 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Virtual exerciseBehavioral: Mobile appsBehavioral: 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.

Behavioral: Exercise resources and information

Interventions

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

Virtual exercise and mobile apps
Mobile appsBEHAVIORAL

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

Virtual exercise and mobile apps

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.

Exercise resources and informationVirtual exercise and mobile apps

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student, Epidemiology & Biostatistics

Study Record Dates

First Submitted

March 28, 2016

First Posted

June 17, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations