Pregnancy RelatedEmbarAppNCT05424237
Efficacy and Feasibility of an eHealth Intervention for Pregnant Women on Diet, Physical Activity and Knowledge Related to Pregnancy
A study testing App intervention in people with Pregnancy Related, run by University of Oviedo at 1 site in Spain.
Trial summary
A pragmatic clinical trial are developed with the aim to assess the effectiveness and feasibility of using an app as complement of the usual care that receive pregnancy women in a sanitary area in the Principado de Asturias (Spain). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- App intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- aged over 18
- pregnant with only 1 fetus
- low risk pregnancy
- smartphone Access
- signed the informed consent
Who cannot join
- non-fluent Spanish speaker
- do not fill the baseline or post-intervention questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
A pragmatic clinical trial are developed with the aim to assess the effectiveness and feasibility of using an app as complement of the usual care that receive pregnancy women in a sanitary area in the Principado de Asturias (Spain).
Participants are pregnancy women attended in the sanitary area number 3 of the Pincipado de Asturias. As inclusion criteria we will consider: i) aged over 18; ii) pregnant with only 1 fetus; iii) low risk pregnancy; iv) smartphone Access; v) signed the informed consent. As exclusion criteria: i) non-fluent Spanish speaker; ii) do not fill the questionnaires.
Read more
A randon sample of 153 women will be recruited consequtively, at the first triemester, from the midwife consulting room. Those women to agreed to participate, and sign the infomred consent, will be anonymizated using a alphanumerical code and asigned (according to a previous randomization distribution by code) to a control or an intervention group.
All women are going to receive the baseline and post intervention questionnaires by email. All women are going to receive the usual care. Adittionally, those in the intervention group, will be prompted to use iNATAL app.
The following questionnaires and measures will be used: uMARS Questionnaire to assess and percentage of app usage tot assess the feasibility; to assess the effectiveness: Motiva.Diaf to assess dietary and physical activity recommendations; ad hoc questionnaire to assess knwoldedge pregnancy related; mother complications during of after the pregnancy period and newborn complications.
The intervention takes all pregnancy period.
- Conditions
- Pregnancy Related
- Being tested
- App intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App interventionBehavioural
usual care plus app ussage with the aim of promote healthy behaviors (diet, physical activity and weight)
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 1. Sign consent form and baseline assessments 2. Usual care 3. Post intervention assessments |
| Interention group | Experimental | 1. Sign consent form and baseline assessments
2. Usual care + app iNATAL
3. Post intervention assessments Receives: Behavioral: App intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Following dietary recommendations (mean)
For both groups. Compliance with dietary recommendations. We are going to use the Motiva.Diaf questionnaire. It includes 7 questions to assess healthy diatery adherence. Response in dichotomous option 0 (not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (null dietary compliance) to 7 (best dietary compliance).
Measured: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
Following physical activity recommendations (mean)
For both groups. Compliance with dietary recommendations. We are going to use the Motiva.Diaf questionnaire. It includes 5 questions to assess healthy diatery adherence. Response in dichotomous option 0 (not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (null dietary compliance) to 5 (best dietary compliance).
Measured: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
Change in pregnancy knwoledge (mean)
For both groups. Ad hoc questionnaire that includes 10 questions related with pregnancy care. Response in dichotomous option 0 (wrong answer) or 1 (correct answer). Total score range from 0 (null knowledge) to 7 (best knowledge).
Measured: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
App ussage
Only for intervention group. Use the app during pregnancy period time. Dichotomous answer (yes or not).
Measured: At the end of the intervention (8-9 after baseline)
Newborn complications (mean)
Number of complication suffer by the newborn in the first week after the birth.
Measured: From birth to one week after.
Women weigh gain (mean)
Weigh improvement in kilograms during the pregnancy period time
Measured: From baseline to the end of the intervention (8-9 months after baseline)
App quality (mean)
Only for intervention group. We are going to use the Spanish version of uMARS to assess the objective and subjetive quality of the app. Both dimensions has a total score range from 1 (lowest quality) to 5 (higher quality).
Measured: At the end of the intervention (8-9 after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 May 2022
- Primary completion26 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Martín Payo, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424237
- Sponsor's protocol ID
- 2021.490
- Acronym
- EmbarApp
- Status last verified
- Dec 2024
- First submitted
- 14 Jun 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Feasibility of an eHealth Intervention for Pregnant Women on Diet, Physical Activity and Knowledge Related to Pregnancy
- ClinicalTrials.gov ID
- NCT05424237
- Acronym / sponsor ID
- EmbarApp / 2021.490
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jun 2022 (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.
A pragmatic clinical trial are developed with the aim to assess the effectiveness and feasibility of using an app as complement of the usual care that receive pregnancy women in a sanitary area in the Principado de Asturias (Spain).
Participants are pregnancy women attended in the sanitary area number 3 of the Pincipado de Asturias. As inclusion criteria we will consider: i) aged over 18; ii) pregnant with only 1 fetus; iii) low risk pregnancy; iv) smartphone Access; v) signed the informed consent. As exclusion criteria: i) non-fluent Spanish speaker; ii) do not fill the questionnaires.
A randon sample of 153 women will be recruited consequtively, at the first triemester, from the midwife consulting room. Those women to agreed to participate, and sign the infomred consent, will be anonymizated using a alphanumerical code and asigned (according to a previous randomization distribution by code) to a control or an intervention group.
All women are going to receive the baseline and post intervention questionnaires by email. All women are going to receive the usual care. Adittionally, those in the intervention group, will be prompted to use iNATAL app.
The following questionnaires and measures will be used: uMARS Questionnaire to assess and percentage of app usage tot assess the feasibility; to assess the effectiveness: Motiva.Diaf to assess dietary and physical activity recommendations; ad hoc questionnaire to assess knwoldedge pregnancy related; mother complications during of after the pregnancy period and newborn complications.
The intervention takes all pregnancy period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –1. Sign consent form and baseline assessments 2. Usual care 3. Post intervention assessments |
| Interention group | Experimental | Behavioral: App intervention1. Sign consent form and baseline assessments 2. Usual care + app iNATAL 3. Post intervention assessments |
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)
- aged over 18
- pregnant with only 1 fetus
- low risk pregnancy
- smartphone Access
- signed the informed consent
Key exclusion criteria (2 listed)
- non-fluent Spanish speaker
- do not fill the baseline or post-intervention questionnaires
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 |
|---|---|---|
| App interventionusual care plus app ussage with the aim of promote healthy behaviors (diet, physical activity and weight) | Behavioural | Interention group |
Primary outcome
Following dietary recommendations (mean)
Time frame: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
For both groups. Compliance with dietary recommendations. We are going to use the Motiva.Diaf questionnaire. It includes 7 questions to assess healthy diatery adherence. Response in dichotomous option 0 (not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (null dietary compliance) to 7 (best dietary compliance).
Following physical activity recommendations (mean)
Time frame: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
For both groups. Compliance with dietary recommendations. We are going to use the Motiva.Diaf questionnaire. It includes 5 questions to assess healthy diatery adherence. Response in dichotomous option 0 (not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (null dietary compliance) to 5 (best dietary compliance).
Change in pregnancy knwoledge (mean)
Time frame: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
For both groups. Ad hoc questionnaire that includes 10 questions related with pregnancy care. Response in dichotomous option 0 (wrong answer) or 1 (correct answer). Total score range from 0 (null knowledge) to 7 (best knowledge).
App ussage
Time frame: At the end of the intervention (8-9 after baseline)
Only for intervention group. Use the app during pregnancy period time. Dichotomous answer (yes or not).
Newborn complications (mean)
Time frame: From birth to one week after.
Number of complication suffer by the newborn in the first week after the birth.
Women weigh gain (mean)
Time frame: From baseline to the end of the intervention (8-9 months after baseline)
Weigh improvement in kilograms during the pregnancy period time
App quality (mean)
Time frame: At the end of the intervention (8-9 after baseline)
Only for intervention group. We are going to use the Spanish version of uMARS to assess the objective and subjetive quality of the app. Both dimensions has a total score range from 1 (lowest quality) to 5 (higher quality).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App intervention in people with Pregnancy Related, run by University of Oviedo 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 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Following dietary recommendations (mean) (time frame: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.