NCT05094479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,047

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

October 22, 2021

Last Update Submit

October 25, 2021

Conditions

Keywords

PregnancyHealth applicationDiet qualityPhysical activityGestational weight gain

Outcome Measures

Primary Outcomes (2)

  • Change in gestational weight

    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

    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 Outcomes (1)

  • Change in physical activity scores

    At enrollment and late pregnancy (pregnancy weeks 35-36)

Study Arms (2)

Health information delivered via health app

EXPERIMENTAL

Use of a health app with health information

Behavioral: Health information delivered via health app

Control

NO INTERVENTION

Use of a health app without health information

Interventions

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.

Health information delivered via health app

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Not pregnant
  • No fluency in Finnish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, Finland

Location

MeSH Terms

Conditions

Feeding BehaviorMotor ActivityGestational Weight Gain

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorWeight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kirsi Laitinen, Assoc. Prof.

    University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2021

First Posted

October 26, 2021

Study Start

June 21, 2017

Primary Completion

June 12, 2018

Study Completion

August 23, 2018

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations