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

Study Overview
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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.

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.

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

Conditions
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Health Behavior, Healthy

Intervention / Treatment
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* Device: WellWe-Intervention group


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WellWe-Intervention group<br>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<br>* 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.<br>|
| No Intervention: Usual care group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at baseline, an average of 2 weeks and an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at baseline and an average of 4 months | 
| 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. | an average of 2 weeks |