Back to resultsE-health App and Lifestyle Changes During Pregnancy (E-HEALTH)
Primary Purpose
Pregnancy, Dietary Habits, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Health information delivered via health app
Sponsored by
About this trial
This is an interventional supportive care trial for Pregnancy focused on measuring Pregnancy, Health application, Diet quality, Physical activity, Gestational weight gain
Eligibility Criteria
Inclusion Criteria:
- Pregnant, less than 28 pregnancy weeks
- Fluency in Finnish
Exclusion Criteria:
- Not pregnant
- No fluency in Finnish
Sites / Locations
- University of Turku
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Health information delivered via health app
Control
Arm Description
Use of a health app with health information
Use of a health app without health information
Outcomes
Primary Outcome Measures
Change in gestational weight
Self-reported weight assessed by a questionnaire
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05094479
First Posted
October 22, 2021
Last Updated
October 25, 2021
Sponsor
University of Turku
Collaborators
Business Finland
1. Study Identification
Unique Protocol Identification Number
NCT05094479
Brief Title
E-health App and Lifestyle Changes During Pregnancy
Acronym
E-HEALTH
Official Title
E-health Application in Supporting Lifestyle Changes During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
June 12, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
Collaborators
Business Finland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Dietary Habits, Physical Activity, Gestational Weight Gain
Keywords
Pregnancy, Health application, Diet quality, Physical activity, Gestational weight gain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1047 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health information delivered via health app
Arm Type
Experimental
Arm Description
Use of a health app with health information
Arm Title
Control
Arm Type
No Intervention
Arm Description
Use of a health app without health information
Intervention Type
Behavioral
Intervention Name(s)
Health information delivered via health app
Intervention Description
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 Outcome Measure Information:
Title
Change in gestational weight
Description
Self-reported weight assessed by a questionnaire
Time Frame
Pre-pregnancy weight reported at enrollment and current weight at late pregnancy (pregnancy weeks 35-36)
Title
Change in diet quality scores
Description
Assessed by a validated Index of Diet Quality (IDQ); scores range from 0 to 15 points with higher scores meaning better diet quality.
Time Frame
At enrollment and late pregnancy (pregnancy weeks 35-36)
Secondary Outcome Measure Information:
Title
Change in physical activity scores
Description
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.
Time Frame
At enrollment and late pregnancy (pregnancy weeks 35-36)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant, less than 28 pregnancy weeks
Fluency in Finnish
Exclusion Criteria:
Not pregnant
No fluency in Finnish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsi Laitinen, Assoc. Prof.
Organizational Affiliation
University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turku
City
Turku
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
E-health App and Lifestyle Changes During Pregnancy
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