Clinical trial NCT05424237: Efficacy and Feasibility of an eHealth Intervention for Pregnant Women on Diet, Physical Activity and Knowledge Related to Pregnancy
Official title: Efficacy and Feasibility of an eHealth Intervention for Pregnant Women on Diet, Physical Activity and Knowledge Related to Pregnancy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Following dietary recommendations (mean)
timeFrame: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
measure: Following physical activity recommendations (mean)
timeFrame: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
measure: Change in pregnancy knwoledge (mean)
timeFrame: Change from Baseline dietary recommendations at 8 or 9 months (depending the pregnancy)
measure: App ussage
timeFrame: At the end of the intervention (8-9 after baseline)
measure: Newborn complications (mean)
timeFrame: From birth to one week after.
measure: Women weigh gain (mean)
timeFrame: From baseline to the end of the intervention (8-9 months after baseline)
measure: App quality (mean)
timeFrame: At the end of the intervention (8-9 after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
References: