NCT03688087

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

September 26, 2018

Last Update Submit

September 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • sleep,

    12 Weeks

  • Well being

    12 Weeks

  • - lumbago

    12 Weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Smartphone application "placebo"

Device: Smartphone application "placebo"

"Bouge"

ACTIVE COMPARATOR

Smartphone equipped with the application "Bouge"

Device: Smartphone equipped with application "bouge" = Coach group

Interventions

Strategy based on smartphone application "placebo"

placebo

Strategy based on smartphone application "bouge"

"Bouge"

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant \<14 weeks of amenorrhea Must have a compatible smartphone

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinique KERAUDREN

Brest, 29200, France

RECRUITING

CHRU de Brest

Brest, 29609, France

RECRUITING

CH de Morlaix

Morlaix, 29672, France

RECRUITING

Chic Quimper

Quimper, 29000, France

RECRUITING

Related Publications (1)

  • 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. 2026 Feb;55(2):102847. doi: 10.1016/j.jogoh.2024.102847. Epub 2024 Sep 12.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 28, 2018

Study Start

August 22, 2017

Primary Completion

October 22, 2018

Study Completion

October 22, 2018

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations