Obese Pregnant WomenPas&PesNCT03706872
Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women (Pas&Pes)
A study testing Intervention group in people with Obese Pregnant Women, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study evaluate the efficacy of an App for monitoring the physical activity and weight with a smart watch and the provision of virtual advice through messages with a mobile phone in obese pregnant women in the second trimester. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obese Pregnant Women
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 1 Apr 2020
- 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 women with BMI ≥ 30 Kg / m2 preconceptional
- Speak Spanish fluently
- Viable singleton non-malformed fetus
- 12-18 weeks of gestation
- Users of Android or Iphone smart mobile phone with internet connection
Who cannot join
- Pregnant women users of a physical activity and weight monitoring App
- Pregnant women with Type I or II Diabetes Mellitus
- Pregnant Women with psychiatric disorders
- Pregnant women with thyroid disorders
- Women with chronic hypertension
- Pregnant women who for some reason have contraindicated the performance of exercise or mobility problems that make it impossible to walk in a moderate way.
- Pregnant women who do not accept to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women
This study evaluate the efficacy of an App for monitoring the physical activity and weight with a smart watch and the provision of virtual advice through messages with a mobile phone in obese pregnant women in the second trimester.
Half of the women will be randomized at the intervention group (App + smart watch) and the other half, to the control group who will receive the usual prenatal care.
Read the detailed description
Randomized controlled trial among obese women. These women will be randomized in two groups in order to evaluate an improvement in several outcomes thanks to different strategies:
Intervention group (IG). An App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care.
Control group. Pregnant women will receive the usual prenatal care. Main hypothesis: In the intervention group pregnant women will improve the weight gain adjusted to the preconception BMI, during pregnanacy, with respect to the pregnant women of the control group.
Secondary hypothesis. In the intervention group pregnant women will improve the physical activity.
- Conditions
- Obese Pregnant Women
- Being tested
- Intervention group
- Keywords
- pregnant women, obesity, Mobile Applications, weight gain, physical activity
- Medical subject headings
- Obesity, Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
The provision of an App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The provision of an App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care. Receives: Other: Intervention group |
| Control Group | No intervention | Provision of usual prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Compare gestational weight gain dring pregnancy in both groups.
Measured: 36 weeks
Physical activity
METS/minutes/week by the "IPAQ Scale" short version
Measured: 36 weeks
Secondary outcomes (3)
Gestational complications
Prevalence of preeclampsia, gestational diabetes.
Measured: 36 weeks
Intrapartum complications
Labor inductions and type of labor
Measured: Labor
perinatal complications
Prevalence of prematurity, macrosomia
Measured: birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start1 Jul 2018
- Primary completion10 Mar 2020
- Study completion1 Apr 2020
Why it stopped: Women's confinement for COVID-19 pandemic and changes on prenatal care.
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 Obese Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 2 arms of intervention
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Gonzalez-Plaza, Hospital Clinic of Barcelona
- Investigators
- Elena González-Plaza, Midwife, Principal investigator, Clinic Hospital of BarcelonaGloria Seguranyes, PhD, Study director, University of BarcelonaJordi Bellart, PhD, Study director, Clinic Hospital of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706872
- Sponsor's protocol ID
- HCB2017/0756
- Acronym
- Pas&Pes
- Status last verified
- May 2020
- First submitted
- 10 Oct 2018
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Plaza E, Bellart J, Arranz A, Lujan-Barroso L, Crespo Mirasol E, Seguranyes G. Effectiveness of a Step Counter Smartband and Midwife Counseling Intervention on Gestational Weight Gain and Physical Activity in Pregnant Women With Obesity (Pas and Pes Study): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Feb 15;10(2):e28886. doi: 10.2196/28886.
PubMed 35166684
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT03706872
- Acronym / sponsor ID
- Pas&Pes / HCB2017/0756
- Conditions
- Obese Pregnant Women
- Keywords
- pregnant women, obesity, Mobile Applications, weight gain, physical activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Women's confinement for COVID-19 pandemic and changes on prenatal care.
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 16 Oct 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.
This study evaluate the efficacy of an App for monitoring the physical activity and weight with a smart watch and the provision of virtual advice through messages with a mobile phone in obese pregnant women in the second trimester.
Half of the women will be randomized at the intervention group (App + smart watch) and the other half, to the control group who will receive the usual prenatal care.
Detailed description
Randomized controlled trial among obese women. These women will be randomized in two groups in order to evaluate an improvement in several outcomes thanks to different strategies:
Intervention group (IG). An App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care.
Control group. Pregnant women will receive the usual prenatal care. Main hypothesis: In the intervention group pregnant women will improve the weight gain adjusted to the preconception BMI, during pregnanacy, with respect to the pregnant women of the control group.
Secondary hypothesis. In the intervention group pregnant women will improve the physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized controlled trial with 2 arms of intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupThe provision of an App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care. |
| Control Group | No intervention | –Provision of usual prenatal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women with BMI ≥ 30 Kg / m2 preconceptional
- Speak Spanish fluently
- Viable singleton non-malformed fetus
- 12-18 weeks of gestation
- Users of Android or Iphone smart mobile phone with internet connection
Key exclusion criteria (7 listed)
- Pregnant women users of a physical activity and weight monitoring App
- Pregnant women with Type I or II Diabetes Mellitus
- Pregnant Women with psychiatric disorders
- Pregnant women with thyroid disorders
- Women with chronic hypertension
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 |
|---|---|---|
| Intervention groupThe provision of an App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care | Other | Intervention group |
Primary outcome
Gestational weight gain
Time frame: 36 weeks
Compare gestational weight gain dring pregnancy in both groups.
Physical activity
Time frame: 36 weeks
METS/minutes/week by the "IPAQ Scale" short version
3 secondary outcomes
Gestational complications
Time frame: 36 weeks
Intrapartum complications
Time frame: Labor
perinatal complications
Time frame: birth
Results and safety
The study was stopped early (reason given: Women's confinement for COVID-19 pandemic and changes on prenatal care.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Derived from this study: PubMed 35166684Gonzalez-Plaza E, Bellart J, Arranz A, Lujan-Barroso L, Crespo Mirasol E, Seguranyes G. Effectiveness of a Step Counter Smartband and Midwife Counseling Intervention on Gestational Weight Gain and Physical Activity in Pregnant Women With Obesity (Pas and Pes Study): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Feb 15;10(2):e28886. doi: 10.2196/28886.
- Individual participant dataSharing planned: No
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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.
Elena González-Plaza, Midwife principal investigator
Clinic Hospital of Barcelona
Gloria Seguranyes, PhD study director
University of Barcelona
Jordi Bellart, PhD study director
Clinic Hospital of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Obese Pregnant Women, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. 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 was stopped early (reason given: Women's confinement for COVID-19 pandemic and changes on prenatal care.). Results are not available in the source record.
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?
Gestational weight gain (time frame: 36 weeks). The study lists 2 primary outcomes in all. 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 NCT03706872, 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 18 May 2020.