E-HEALTH: E-health App and Lifestyle Changes During Pregnancy

Sponsor
University of Turku (Other)
Overall Status
Completed
CT.gov ID
NCT05094479
Collaborator
Business Finland (Other)
1,047
1
2
14.1
74.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Health information delivered via health app
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1047 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
E-health Application in Supporting Lifestyle Changes During Pregnancy
Actual Study Start Date :
Jun 21, 2017
Actual Primary Completion Date :
Jun 12, 2018
Actual Study Completion Date :
Aug 23, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in gestational weight [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 [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 Outcome Measures

  1. Change in physical activity scores [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnant, less than 28 pregnancy weeks

  • Fluency in Finnish

Exclusion Criteria:
  • Not pregnant

  • No fluency in Finnish

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Turku Turku Finland

Sponsors and Collaborators

  • University of Turku
  • Business Finland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kirsi Laitinen, Associate Professor, University of Turku
ClinicalTrials.gov Identifier:
NCT05094479
Other Study ID Numbers:
  • E-HEALTH
First Posted:
Oct 26, 2021
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kirsi Laitinen, Associate Professor, University of Turku
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2021