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Completed

NCT Number: NCT05094479

E-health App and Lifestyle Changes During Pregnancy

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.

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Key information

Conditions

Pregnancy Behavior Behavior, Animal Body Weight Body Weight Changes Dietary Habits Feeding Behavior Gestational Weight Gain Motor Activity Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Weight Gain

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Turku

Turku, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant, less than 28 pregnancy weeks
  • Fluency in Finnish

Exclusion criteria

  • Not pregnant
  • No fluency in Finnish

Treatment and study plan

Health information delivered via health app

Behavioral

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.

Primary outcomes

  1. Change in gestational weight

    Time frame: Pre-pregnancy weight reported at enrollment and current weight at late pregnancy (pregnancy weeks 35-36)

    Self-reported weight assessed by a questionnaire

  2. Change in diet quality scores

    Time frame: At enrollment and late pregnancy (pregnancy weeks 35-36)

    Assessed by a validated Index of Diet Quality (IDQ); scores range from 0 to 15 points with higher scores meaning better diet quality.

Secondary outcomes

  1. Change in physical activity scores

    Time frame: At enrollment and late pregnancy (pregnancy weeks 35-36)

    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.

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Business Finland

Registry information

Official study title

E-health Application in Supporting Lifestyle Changes During Pregnancy

Acronym: E-HEALTH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2021
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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