PregnancyE-HEALTHNCT05094479
E-health App and Lifestyle Changes During Pregnancy
A study testing Health information delivered via health app in people with Pregnancy and Dietary Habits, run by University of Turku at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Dietary Habits, Physical Activity
- What is being tested?
- Health information delivered via health app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,047 participants
- Where
- 1 siteFinland
- Study dates
- 21 Jun 2017to 23 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant, less than 28 pregnancy weeks
- Fluency in Finnish
Who cannot join
- Not pregnant
- No fluency in Finnish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, Dietary Habits, Physical Activity, Gestational Weight Gain
- Being tested
- Health information delivered via health app
- Keywords
- Pregnancy, Health application, Diet quality, Physical activity, Gestational weight gain
- Medical subject headings
- Feeding Behavior, Motor Activity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health information delivered via health appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health information delivered via health app | Experimental | Use of a health app with health information Receives: Behavioral: Health information delivered via health app |
| Control | No intervention | Use of a health app without health information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gestational weight
Self-reported weight assessed by a questionnaire
Measured: 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.
Measured: At enrollment and late pregnancy (pregnancy weeks 35-36)
Secondary outcomes (1)
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.
Measured: At enrollment and late pregnancy (pregnancy weeks 35-36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start21 Jun 2017
- Primary completion12 Jun 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,047 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Business Finland
- Responsible party
- Principal investigator, Kirsi Laitinen, University of Turku
- Investigators
- Kirsi Laitinen, Assoc. Prof., Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094479
- Sponsor's protocol ID
- E-HEALTH
- Acronym
- E-HEALTH
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-health Application in Supporting Lifestyle Changes During Pregnancy
- ClinicalTrials.gov ID
- NCT05094479
- Acronym / sponsor ID
- E-HEALTH / E-HEALTH
- Conditions
- Pregnancy, Dietary Habits, Physical Activity, Gestational Weight Gain
- Keywords
- Pregnancy, Health application, Diet quality, Physical activity, Gestational weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,047 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Business Finland
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health information delivered via health app | Experimental | Behavioral: Health information delivered via health appUse of a health app with health information |
| Control | No intervention | –Use of a health app without health information |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant, less than 28 pregnancy weeks
- Fluency in Finnish
Key exclusion criteria (2 listed)
- Not pregnant
- No fluency in Finnish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health information delivered via health appIntervention 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. | Behavioural | Health information delivered via health app |
Primary outcome
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
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.
1 secondary outcome
Change in physical activity scores
Time frame: At enrollment and late pregnancy (pregnancy weeks 35-36)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsi Laitinen, Assoc. Prof. principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health information delivered via health app in people with Pregnancy and Dietary Habits, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gestational weight (time frame: Pre-pregnancy weight reported at enrollment and current weight at late pregnancy (pregnancy weeks 35-36)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.