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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03278288
• Other study ID #: WellWeF2017
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2017
• Last updated: September 8, 2017
• Start date: May 15, 2017
• Est. completion date: May 2018

Study information

• Verified date: September 2017
• Source: University of Turku
• Contact: Anni Pakarinen, MHSc
• Phone: +358451213567
• Email: anni.pakarinen[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• Healthy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Finland	Child health clinics	Four Municipalities	Southwest Finland

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	at baseline
Primary	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	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
Secondary	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