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NCT Number: NCT05424237

Efficacy and Feasibility of an eHealth Intervention for Pregnant Women on Diet, Physical Activity and Knowledge Related to Pregnancy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged over 18
  • pregnant with only 1 fetus
  • low risk pregnancy
  • smartphone Access
  • signed the informed consent

Exclusion criteria

  • non-fluent Spanish speaker
  • do not fill the baseline or post-intervention questionnaires

Treatment and study plan

App intervention

Behavioral

usual care plus app ussage with the aim of promote healthy behaviors (diet, physical activity and weight)

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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

  7. 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).

Sponsors and collaborators

Lead sponsor

University of Oviedo

Other

Registry information

Acronym: EmbarApp

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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