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

NCT ID: NCT03688087

Last Updated: 2018-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-22

Study Completion Date

2018-10-22

Brief Summary

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

Detailed Description

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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)

Conditions

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Physical Activity Pregnant Mobile Health Apps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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placebo

Smartphone application "placebo"

Group Type PLACEBO_COMPARATOR

Smartphone application "placebo"

Intervention Type DEVICE

Strategy based on smartphone application "placebo"

"Bouge"

Smartphone equipped with the application "Bouge"

Group Type ACTIVE_COMPARATOR

Smartphone equipped with application "bouge" = Coach group

Intervention Type DEVICE

Strategy based on smartphone application "bouge"

Interventions

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Smartphone application "placebo"

Strategy based on smartphone application "placebo"

Intervention Type DEVICE

Smartphone equipped with application "bouge" = Coach group

Strategy based on smartphone application "bouge"

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique KERAUDREN

Brest, , France

Site Status RECRUITING

CHRU de Brest

Brest, , France

Site Status RECRUITING

CH de Morlaix

Morlaix, , France

Site Status RECRUITING

Chic Quimper

Quimper, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Matthieu MULLER

Role: CONTACT

Phone: 02 98 62 60 77

Email: [email protected]

Facility Contacts

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Gilles SALNELLE

Role: primary

Philippe MERVIEL

Role: primary

matthieu Muller

Role: primary

Charles BELLOT

Role: primary

References

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Muller M, James P, Merviel P, Saraux A, Guillodo Y, Kerlan V, Bouee S, Nowak E, Morgant R, Communier-Courtois E. A smartphone coaching program ("Bouge Grossesse") improves daily physical activity in pregnant women. J Gynecol Obstet Hum Reprod. 2024 Sep 12:102847. doi: 10.1016/j.jogoh.2024.102847. Online ahead of print.

Reference Type DERIVED
PMID: 39277170 (View on PubMed)

Other Identifiers

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BOUGE GROSSESSE (29BRC17.0108)

Identifier Type: -

Identifier Source: org_study_id