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Study of Programm Interest 'Bouge' to Improve the Daily Physical Activity at the Pregnant Women. (BOUGE GROSSESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of pregnant patients beguining at 15 SA

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

Detailed Description:

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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"




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. sleep, [ Time Frame: 12 Weeks ]
    Scale Spiegel

  2. Well being [ Time Frame: 12 Weeks ]
    Scale OMS

  3. - lumbago [ Time Frame: 12 Weeks ]
    Scale EIFEL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Pregnant <14 weeks of amenorrhea Must have a compatible smartphone

Exclusion Criteria:

Multiple pregnancies Pre-existing pregnancy-related diseases Pregnancy complicated History of peripheral arterial disease History of IUGR History of cone biopsy History of delivery hemorrhage


Information from the National Library of Medicine

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


Contacts
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Contact: Matthieu MULLER 02 98 62 60 77 mmuller@ch-morlaix.fr

Locations
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France
Clinique KERAUDREN Recruiting
Brest, France, 29200
Contact: Gilles SALNELLE         
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Philippe MERVIEL       philippe.merviel@chu-brest.fr   
CH de Morlaix Recruiting
Morlaix, France, 29672
Contact: matthieu Muller       m.muller@chu-morlaix.fr   
Chic Quimper Recruiting
Quimper, France, 29000
Contact: Charles BELLOT       charles.bellot@ch-quimper.fr   
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03688087    
Other Study ID Numbers: BOUGE GROSSESSE (29BRC17.0108)
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No