Clinical trial NCT03278288: Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children
Official title: Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Healthy
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Parental Self-Efficacy for Healthy Dietary and Physical Activity Behaviors in Preschoolers Scale (PDAP)
timeFrame: at baseline, an average of 2 weeks and an average of 4 months
Secondary outcomes:
measure: Change in Mindfulness In Parenting Questionnaire (MIPQ)
timeFrame: at baseline and an average of 4 months
measure: Questionnaire on the family-centered approach of the health visit
timeFrame: an average of 2 weeks
Other outcomes:
measure: Questionnaire on the background information on the family
timeFrame: at baseline
Locations:
city: Four Municipalities
country: Finland
facility: Child health clinics
state: Southwest Finland
Study officials:
affiliation: University of Turku, Finland
name: Anni Pakarinen, MHSc
role: PRINCIPAL_INVESTIGATOR
References: