E-health App and Lifestyle Changes During Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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E-health Application in Supporting Lifestyle Changes During Pregnancy

Conditions
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Pregnancy, Dietary Habits, Physical Activity, Gestational Weight Gain

Intervention / Treatment
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* Behavioral: Health information delivered via health app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant, less than 28 pregnancy weeks Fluency in Finnish Exclusion Criteria: Not pregnant No fluency in Finnish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health information delivered via health app<br>Use of a health app with health information | Behavioral: Health information delivered via health app<br>* 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.<br>|
| No Intervention: Control<br>Use of a health app without health information | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Health application, Diet quality, Physical activity, Gestational weight gain