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

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 Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Behavioral: App intervention

• Study Type: Interventional
• Enrollment (Estimated): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • University of Oviedo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Sign consent form and baseline assessments; Usual care; Post intervention assessments
Experimental: Interention group; Sign consent form and baseline assessments; Usual care + app iNATAL; Post intervention assessments	Behavioral: App intervention; usual care plus app ussage with the aim of promote healthy behaviors (diet, physical activity and weight)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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.	From birth to one week after.
Women weigh gain (mean)	Weigh improvement in kilograms during the pregnancy period time	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).	At the end of the intervention (8-9 after baseline)

Collaborators and Investigators

• Sponsor: University of Oviedo

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 26, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021.490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No