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Status unknownNCT03278288Updated Sep 11, 2017

Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children

An interventional study of WellWe-Intervention group in Health Behavior and Healthy, sponsored by University of Turku. Status unknown at 1 site in Finland. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by University of Turku · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2017, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study summary

The study evaluates the effectiveness of the WellWe-intervention in promotion of parental self-efficacy for healthy behaviors and mindfulness in parenting from the perspective of families. Aim is also to evaluate the effectiveness of the WellWe-intervention in facilitation of family-centered approach of the health visit in Child health clinic perceived by the families and Public health nurses (PHN). Half of the participants will receive WellWe-intervention and half of the participants will receive usual care.

Read the detailed description

Families with pre-school aged children attend to regular health visits in Child health clinics on a yearly basis. During the health visits PHNs assess and promote the health and wellbeing of the whole family through health discussions.

In this study we aim to evaluate whether the addition of gamified method into the health discussion promotes healthy behaviors and mindfulness of the families and increases the family-centered approach of health visit compared to the traditional method.

WellWe-intervention includes the use of gamified WellWe app at home and during the health discussion in the Child health clinic. Usual care includes paper-based questionnaires filled by the parents and health discussion using these questionnaires in the Child health clinic.

02

Conditions studied

  • Health Behavior
  • Healthy

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03

In context

Health Behavior

968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.

This study's planned enrollment of 200 is above the median of 150 across 825 interventional studies indexed under Health Behavior.

Browse Health Behavior studies →

Lead sponsor

University of Turku is the lead sponsor of 122 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • families: Finnish speaking families with 4-year old child and attend into health visit in Child health clinic during data collection period.
  • PHNs: a permanent employee in Child health clinic or deputy employee working in Child health clinic during the data collection period.

Exclusion criteria

Exclusion Criteria:

  • families: Child is developmentally disabled to participate to the use of WellWe-app with parents.
  • PHNs: Deputy employees working in Child health clinic only a short period of time or temporarily.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    WellWe-Intervention group

    WellWe-intervention includes the use of WellWe-app to assess the current situation of the wellbeing of the family at home and utilizing these results using WellWe-app during the health visit in Child health clinic.

    Device: WellWe-Intervention group

  • No intervention
    Usual care group

    Usual care includes the filling of normal paper-based questionnaires to assess the current situation of the wellbeing of the family at home and utilizing these results during the normal health visit in Child health clinic.

Interventions

  • DeviceWellWe-Intervention group

    Participants (families) allocated to the intervention group get to use WellWe-app before entering to health visit to assess the current situation of their wellbeing and utilizing these results during the health visit. The access to WellWe-app is permitted throughout the data collection period. Participants (PHNs) randomized to the intervention group get standardized two hour WellWe-training, WellWe-handbook and full access to the WellWe-app during the data collection period.

06

What researchers measure

Primary outcomes

  1. Change in Parental Self-Efficacy for Healthy Dietary and Physical Activity Behaviors in Preschoolers Scale (PDAP)

    In this study we use version of the PDAP consisting of 21 items covering contextual circumstances that may either facilitate or impede parental self-efficacy (PSE) for promoting healthy dietary and physical activity behaviors in preschool children. Responses are made on an 11-point Likert scale, with anchors at 0 (not at all confident), 5 (moderately confident), and 10 (completely confident).

    Time frame: at baseline, an average of 2 weeks and an average of 4 months

Secondary outcomes

  1. Change in Mindfulness In Parenting Questionnaire (MIPQ)

    In this study we use the version of the MIPQ including 28 items. For each item, parents respond using a four-point Likert-type rating scale: infrequently (1), sometimes (2), often (3), or almost always (4).

    Time frame: at baseline and an average of 4 months

  2. Questionnaire on the family-centered approach of the health visit

    Questionnaire developed for the purpose of the study for families consists of 6 dichotomous questions (yes/no) and one open-ended question. Questionnaire for the PHNs consists of 3 dichotomous questions (yes/no) and 3 items with four-point Likert-type rating scale and one open-ended question.

    Time frame: an average of 2 weeks

Other outcomes

  1. Questionnaire on the background information on the family

    Questionnaire developed for the study purposes includes questions of the respondent's gender, age, education, occupation, family circumstances.

    Time frame: at baseline

07

Study locations

1 of 1 sites recruiting
  • Child health clinics
    Four Municipalities, Southwest Finland, Finland
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2017 (actual). Primary completion is estimated for May 2018, 12 months after the start.

Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 12 months is below that.

Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2017
First posted
Sep 11, 2017
StartActual
May 15, 2017
Primary completionEst.
May 2018
CompletionEst.
May 2018
Last update
Sep 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03278288
Responsible party
Anni Pakarinen (Doctoral candidate, University of Turku) — Principal investigator
First posted
Sep 11, 2017
Start date
May 15, 2017
Primary completion
May 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Sep 11, 2017

Study contacts

Anni Pakarinen, MHSc
Contact
anni.pakarinen@utu.fi
+358451213567
Anni Pakarinen, MHSc
principal investigator · University of Turku, Finland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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