Physical ActivityNCT01461707
The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women
A study testing Mobile phone-based physical activity and Activity monitor in people with Physical Activity, run by University of California, San Francisco at 1 site in United States.
Trial summary
Obesity among women of childbearing age and excessive weight gain during pregnancy are prevalent and steadily increasing health care issues. Regular physical activity is recommended to maintain healthy weight gain for pregnant women, however, a majority of pregnant women are sedentary. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Mobile phone-based physical activity and Activity monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant, gestational week (10-20 weeks)
- pre-pregnancy BMI ≥ 18.5 kg•m2
- physically inactive at work and during leisure time
- intent to be physically active
- access to a home telephone or a mobile phone
- have a personal computer access
- ability to communicate (speak and read) in English.
Who cannot join
- known medical or obstetric complication that restricts physical activity
- history of eating disorders
- current participation in lifestyle modification programs
- history of bariatric surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: A Pilot Study of a Mobile Phone-Based Physical Activity Program in Pregnant Women
Obesity among women of childbearing age and excessive weight gain during pregnancy are prevalent and steadily increasing health care issues. Regular physical activity is recommended to maintain healthy weight gain for pregnant women, however, a majority of pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate the potential efficacy of a mobile phone based physical activity intervention in 30 physically inactive pregnant women.
- Conditions
- Physical Activity
- Being tested
- Mobile phone-based physical activity, Activity monitor
- Keywords
- Cellular phone, exercise, pregnant women, obesity, overweight, physical activity
- Medical subject headings
- Motor Activity, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone-based physical activityBehavioural
Participants will receive the mobile phone-based physical activity program using the trial app.
Activity monitorBehavioural
Participants will receive an activity monitor
| Study group | Role | What they receive |
|---|---|---|
| Mobile app plus activity monitor group | Experimental | Participants in the group will receive the mobile phone-based physical activity program and an activity monitor Receives: Behavioral: Mobile phone-based physical activity; Behavioral: Activity monitor |
| Activity monitor group | Active comparator | Participants in the group will receive an activity monitor Receives: Behavioral: Activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Monitor Measured Steps
Change in weekly mean steps per day
Measured: 12 weeks
Secondary outcomes (1)
7-Day Physical Activity Recall
Change in mean energy expenditure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- JiWon Choi, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461707
- Sponsor's protocol ID
- 11-06992
- Other IDs
- 3R01HL104147-02S1
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2011
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Choi J, Lee JH, Vittinghoff E, Fukuoka Y. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women. Matern Child Health J. 2016 May;20(5):1091-101. doi: 10.1007/s10995-015-1895-7.
PubMed 26649879
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Mobile Phone-Based Physical Activity Program in Pregnant Women
- ClinicalTrials.gov ID
- NCT01461707
- Acronym / sponsor ID
- 11-06992
- Conditions
- Physical Activity
- Keywords
- Cellular phone, exercise, pregnant women, obesity, overweight, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity among women of childbearing age and excessive weight gain during pregnancy are prevalent and steadily increasing health care issues. Regular physical activity is recommended to maintain healthy weight gain for pregnant women, however, a majority of pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate the potential efficacy of a mobile phone based physical activity intervention in 30 physically inactive pregnant women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile app plus activity monitor group | Experimental | Behavioral: Mobile phone-based physical activity, Behavioral: Activity monitorParticipants in the group will receive the mobile phone-based physical activity program and an activity monitor |
| Activity monitor group | Active comparator | Behavioral: Activity monitorParticipants in the group will receive an activity monitor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- pregnant, gestational week (10-20 weeks)
- pre-pregnancy BMI ≥ 18.5 kg•m2
- physically inactive at work and during leisure time
- intent to be physically active
- access to a home telephone or a mobile phone
Key exclusion criteria (4 listed)
- known medical or obstetric complication that restricts physical activity
- history of eating disorders
- current participation in lifestyle modification programs
- history of bariatric surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile phone-based physical activityParticipants will receive the mobile phone-based physical activity program using the trial app. | Behavioural | Mobile app plus activity monitor group |
| Activity monitorParticipants will receive an activity monitor | Behavioural | Activity monitor group, Mobile app plus activity monitor group |
Primary outcome
Physical Activity Monitor Measured Steps
Time frame: 12 weeks
Change in weekly mean steps per day
1 secondary outcome
7-Day Physical Activity Recall
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26649879Choi J, Lee JH, Vittinghoff E, Fukuoka Y. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women. Matern Child Health J. 2016 May;20(5):1091-101. doi: 10.1007/s10995-015-1895-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JiWon Choi, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone-based physical activity and Activity monitor in people with Physical Activity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Monitor Measured Steps (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.