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NCT03688087 Clinical Trial

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

Physical Activity Clinical Trial

— BOUGE GROSSESS  

Official title:
Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03688087
Other study ID # BOUGE GROSSESSE (29BRC17.0108)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 22, 2017
Est. completion date October 22, 2018

Study information
Verified date September 2018
Source University Hospital, Brest
Contact Matthieu MULLER
Phone 02 98 62 60 77
Email mmuller@ch-morlaix.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date October 22, 2018
Est. primary completion date October 22, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Smartphone application "placebo"
Strategy based on smartphone application "placebo"
• Smartphone equipped with application "bouge" = Coach group
Strategy based on smartphone application "bouge"

Locations
Country Name City State
France CHRU de Brest Brest
France Clinique KERAUDREN Brest
France CH de Morlaix Morlaix
France Chic Quimper Quimper

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increased daily physical activity (number of steps) using the smartphone application "BOUGE" 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 sleep, Scale Spiegel 12 Weeks
Secondary Well being Scale OMS 12 Weeks
Secondary — lumbago Scale EIFEL 12 Weeks
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