Physical ActivityBOUGE GROSSESSNCT03688087
Study of Programm Interest 'Bouge' to Improve the Daily Physical Activity at the Pregnant Women.
A study testing Smartphone equipped with application "bouge" = Coach group in people with Physical Activity and Pregnant, run by University Hospital, Brest at 4 sites in France.
Trial summary
Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of pregnant patients beguining at 15 SA Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Physical Activity, Pregnant, Mobile Health Apps
- What is being tested?
- Smartphone equipped with application "bouge" = Coach group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 4 sitesFrance
- Study dates
- 22 Aug 2017to 27 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant <14 weeks of amenorrhea Must have a compatible smartphone
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinique KERAUDREN
Brest, 29200
CHRU de Brest
Brest, 29609
CH de Morlaix
Morlaix, 29672
Chic Quimper
Quimper, 29000
About this study
Official title: Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Pregnant Women
Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of pregnant patients beguining at 15 SA
Read the 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)
- Conditions
- Physical Activity, Pregnant, Mobile Health Apps
- Being tested
- Smartphone application "placebo", Smartphone equipped with application "bouge" = Coach group
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone application "placebo"Device
Strategy based on smartphone application "placebo"
Smartphone equipped with application "bouge" = Coach groupDevice
Strategy based on smartphone application "bouge"
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Smartphone application "placebo" Receives: Device: Smartphone application "placebo" |
| "Bouge" | Active comparator | Smartphone equipped with the application "Bouge" Receives: Device: Smartphone equipped with application "bouge" = Coach group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 Weeks
Secondary outcomes (3)
sleep,
Scale Spiegel
Measured: 12 Weeks
Well being
Scale OMS
Measured: 12 Weeks
- lumbago
Scale EIFEL
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start22 Aug 2017
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688087
- Sponsor's protocol ID
- BOUGE GROSSESSE (29BRC17.0108)
- Acronym
- BOUGE GROSSESS
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2018
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39277170
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Pregnant Women
- ClinicalTrials.gov ID
- NCT03688087
- Acronym / sponsor ID
- BOUGE GROSSESS / BOUGE GROSSESSE (29BRC17.0108)
- Conditions
- Physical Activity, Pregnant, Mobile Health Apps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Device: Smartphone application "placebo"Smartphone application "placebo" |
| "Bouge" | Active comparator | Device: Smartphone equipped with application "bouge" = Coach groupSmartphone equipped with the application "Bouge" |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant <14 weeks of amenorrhea Must have a compatible smartphone
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone application "placebo"Strategy based on smartphone application "placebo" | Device | placebo |
| Smartphone equipped with application "bouge" = Coach groupStrategy based on smartphone application "bouge" | Device | "Bouge" |
Primary outcome
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)
3 secondary outcomes
sleep,
Time frame: 12 Weeks
Well being
Time frame: 12 Weeks
- lumbago
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 39277170Muller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone equipped with application "bouge" = Coach group in people with Physical Activity and Pregnant, run by University Hospital, Brest at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased daily physical activity (number of steps) using the smartphone application "BOUGE" (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.