- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03688087
Study of Programm Interest 'Bouge' to Improve the Daily Physical Activity at the Pregnant Women. (BOUGE GROSSESS)
Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Pregnant Women
Study Overview
Status
Conditions
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brest, France, 29609
- CHRU de Brest
-
Brest, France, 29200
- Clinique KERAUDREN
-
Morlaix, France, 29672
- CH de Morlaix
-
Quimper, France, 29000
- CHIC Quimper
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
Smartphone application "placebo"
|
Strategy based on smartphone application "placebo"
|
|
Active Comparator: "Bouge"
Smartphone equipped with the application "Bouge"
|
Strategy based on smartphone application "bouge"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep,
Time Frame: 12 Weeks
|
Scale Spiegel
|
12 Weeks
|
|
Well being
Time Frame: 12 Weeks
|
Scale OMS
|
12 Weeks
|
|
- lumbago
Time Frame: 12 Weeks
|
Scale EIFEL
|
12 Weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOUGE GROSSESSE (29BRC17.0108)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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