- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03278288
Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anni Pakarinen, MHSc
- Phone Number: +358451213567
- Email: anni.pakarinen@utu.fi
Study Locations
-
-
Southwest Finland
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Four Municipalities, Southwest Finland, Finland
- Recruiting
- Child health clinics
-
Contact:
- Anni Pakarinen
- Phone Number: +358451213567
- Email: anni.pakarinen@utu.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
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)
Time Frame: at baseline, an average of 2 weeks and an average of 4 months
|
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)
Time Frame: at baseline and an average of 4 months
|
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).
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at baseline and an average of 4 months
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Questionnaire on the family-centered approach of the health visit
Time Frame: an average of 2 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire on the background information on the family
Time Frame: at baseline
|
Questionnaire developed for the study purposes includes questions of the respondent's gender, age, education, occupation, family circumstances.
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at baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anni Pakarinen, MHSc, University of Turku, Finland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WellWeF2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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