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

Study acronym: EmbarApp
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: May 30, 2023 to Dec 26, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2025
    v5
  2. Notable Lead sponsor: Rubén Martín Payo to University of Oviedo
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 31, 2023 to Dec 31, 2023
    • Site details revised
    v4
  3. Notable Primary completion date: Nov 30, 2022 to May 30, 2023
    • Study completion date: Jan 31, 2023 to Jul 31, 2023
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05424237
Lead Sponsor University of Oviedo
Conditions
(from sponsor)
Pregnancy Related
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov