E-health App and Lifestyle Changes During Pregnancy (E-HEALTH)

October 25, 2021 updated by: Kirsi Laitinen, University of Turku

E-health Application in Supporting 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1047

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not pregnant
  • No fluency in Finnish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health information delivered via health app
Use of a health app with health information
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.
No Intervention: Control
Use of a health app without health information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-pregnancy weight reported at enrollment and current weight at late pregnancy (pregnancy weeks 35-36)
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.
At enrollment and late pregnancy (pregnancy weeks 35-36)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrollment and late pregnancy (pregnancy weeks 35-36)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Business Finland

Investigators

  • Principal Investigator: Kirsi Laitinen, Assoc. Prof., University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2017

Primary Completion (Actual)

June 12, 2018

Study Completion (Actual)

August 23, 2018

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-HEALTH

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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