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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Health Behavior Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm cluster randomized controlled trial and conducted in four municipalities located in the Southwest Finland. The unit of randomization is one cluster, with one municipality with its Child health clinics representing one cluster. Two municipalities with all together eight Child health clinics are randomly allocated into the intervention arm and two municipalities with all together seven Child health clinics are randomly allocated into the control arm.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Family participants are masked and control group is not aware of the intervention condition. PHN participants are not masked.

Study Groups

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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.

Group Type EXPERIMENTAL

WellWe-Intervention group

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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WellWe-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.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes