E-health App and Lifestyle Changes During Pregnancy

Pregnancy Clinical Trial

— E-HEALTH  

Official title:

E-health Application in Supporting Lifestyle Changes During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094479
• Other study ID #: E-HEALTH
• Status: Completed
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: August 23, 2018

Study information

• Verified date: October 2021
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this online follow-up study is to investigate health app use in pregnant women and through a pilot intervention trial investigate whether the addition of evidence-based information on health-promoting lifestyle delivered via the health app has an effect on lifestyle habits (gestational weight, diet quality and physical activity) during pregnancy.

Description:

An online follow-up study with a 2-arm equal allocation parallel randomized controlled pilot intervention trial with pregnant women (n=1000) will be conducted. The intervention consists of non-personalized, evidence-based information on health-promoting lifestyle during pregnancy delivered via a health app. Control group uses the health app without health information.

Aims of an exploratory part of the study are to characterize the health app use and users among pregnant women and to investigate whether the frequency of the health app use during pregnancy has an effect on lifestyle habits. Aim of the pilot intervention is to investigate whether the addition of evidence-based information on health-promoting lifestyle delivered via the health app has an effect on lifestyle habits during pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1047
• Est. completion date: August 23, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant, less than 28 pregnancy weeks

• Fluency in Finnish

Exclusion Criteria:

• Not pregnant

• No fluency in Finnish

Related Conditions & MeSH terms

• Dietary Habits
• Gestational Weight Gain
• Physical Activity
• Pregnancy
• Weight Gain

Intervention

Behavioral:
• Health information delivered via health app
Intervention group will use a health app with non-personalized information on health-promoting lifestyle habits during pregnancy. Control group will use a health app without health information. Intervention effects on the lifestyle habits (gestational weight gain, diet quality, physical activity) will be investigated.

Locations

Country	Name	City	State
Finland	University of Turku	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Business Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gestational weight	Self-reported weight assessed by a questionnaire	Pre-pregnancy weight reported at enrollment and current weight at late pregnancy (pregnancy weeks 35-36)
Primary	Change in diet quality scores	Assessed by a validated Index of Diet Quality (IDQ); scores range from 0 to 15 points with higher scores meaning better diet quality.	At enrollment and late pregnancy (pregnancy weeks 35-36)
Secondary	Change in physical activity scores	Assessed by a validated metabolic equivalent (MET)-index; scores range from 0 to 105 MET h/wk with higher scores meaning more vigorous physical activity.	At enrollment and late pregnancy (pregnancy weeks 35-36)