Study of Programm Interest 'Bouge' to Improve the Daily Physical Activity at the Pregnant Women. (BOUGE GROSSESS)
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|ClinicalTrials.gov Identifier: NCT03688087|
Recruitment Status : Unknown
Verified September 2018 by University Hospital, Brest.
Recruitment status was: Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Pregnant Mobile Health Apps||Device: Smartphone application "placebo" Device: Smartphone equipped with application "bouge" = Coach group||Not Applicable|
Controlled, randomized, open, prospective, multicentric study, 250 pregnant patients aged between 18 and more, with 14 weeks of amenorrhea, possessing a smartphone, will be recruited and randomized into two groups:
125 in the control group (smartphone application "placebo" = number of steps) 125 will be equipped with the application "Bouge" = coached group
For three months, the patients do their daily physical activity. The "coached" group, through the smartphone application "Bouge", receives computer coaching to increase their physical activity (no direct medical intervention, only notifications and computer pusch).
The control group is not coached by the application (simple display of the number of step)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Pregnant Women|
|Actual Study Start Date :||August 22, 2017|
|Estimated Primary Completion Date :||October 22, 2018|
|Estimated Study Completion Date :||October 22, 2018|
Placebo Comparator: placebo
Smartphone application "placebo"
Device: Smartphone application "placebo"
Strategy based on smartphone application "placebo"
Active Comparator: "Bouge"
Smartphone equipped with the application "Bouge"
Device: Smartphone equipped with application "bouge" = Coach group
Strategy based on smartphone application "bouge"
- Increased daily physical activity (number of steps) using the smartphone application "BOUGE" [ Time Frame: 12 Weeks ]The objective is an increase of 2000 steps daily between J 1 and J 90 (an increase of 10 000 steps between S1 and S 12)
- sleep, [ Time Frame: 12 Weeks ]Scale Spiegel
- Well being [ Time Frame: 12 Weeks ]Scale OMS
- - lumbago [ Time Frame: 12 Weeks ]Scale EIFEL
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): NCT03688087
|Contact: Matthieu MULLER||02 98 62 60 email@example.com|
|Brest, France, 29200|
|Contact: Gilles SALNELLE|
|CHRU de Brest||Recruiting|
|Brest, France, 29609|
|Contact: Philippe MERVIEL firstname.lastname@example.org|
|CH de Morlaix||Recruiting|
|Morlaix, France, 29672|
|Contact: matthieu Muller email@example.com|
|Quimper, France, 29000|
|Contact: Charles BELLOT firstname.lastname@example.org|