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

Pregnancy Related Clinical Trial

— EmbarApp  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05424237
• Other study ID #: 2021.490
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: University of Oviedo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 153
• Est. completion date: December 31, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
Spain	University of Oviedo	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
University of Oviedo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Newborn complications (mean)	Number of complication suffer by the newborn in the first week after the birth.	From birth to one week after.
Primary	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)
Primary	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)