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

University of Oviedo

Status: Active, not recruiting

Conditions: Pregnancy Related

Treatments: Behavioral: App intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05424237

2021.490

Details and patient eligibility

About

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.

Enrollment: 153 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 2 patient groups

Control group

No Intervention group

Description:

1. Sign consent form and baseline assessments 2. Usual care 3. Post intervention assessments

Interention group

Experimental group

Description:

1. Sign consent form and baseline assessments 2. Usual care + app iNATAL 3. Post intervention assessments

Treatment:

Behavioral: App intervention