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

Not Applicable

• Conditions: Mobile Health Apps; Physical Activity; Pregnant
• Interventions: Device: Smartphone equipped with application "bouge" = Coach group; Device: Smartphone application "placebo"

• Registration Number: NCT03688087
• Lead Sponsor: 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

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 Timeline

• Study Start: 2017-08-22
• Status Verified: 2018-09
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-27
• Last Update Submitted: 2018-09-27
• Study First Posted: 2018-09-28
• Last Update Posted: 2018-09-28
• Primary Completion: 2018-10-22
• Study Completion: 2018-10-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Bouge"	Smartphone equipped with application "bouge" = Coach group	Smartphone equipped with the application "Bouge"
placebo	Smartphone application "placebo"	Smartphone application "placebo"

Primary Outcome Measures

Name	Time	Method
Increased daily physical activity (number of steps) using the smartphone application "BOUGE"	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

Name	Time	Method
Well being	12 Weeks	Scale OMS
sleep,	12 Weeks	Scale Spiegel
- lumbago	12 Weeks	Scale EIFEL

Trial Locations

Locations (4)

CH de Morlaix; 🇫🇷 Morlaix, France

CHRU de Brest; 🇫🇷 Brest, France

Chic Quimper; 🇫🇷 Quimper, France

Clinique KERAUDREN; 🇫🇷 Brest, France