Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children
|ClinicalTrials.gov Identifier: NCT03278288|
Recruitment Status : Unknown
Verified September 2017 by Anni Pakarinen, University of Turku.
Recruitment status was: Recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Health Behavior Healthy||Device: WellWe-Intervention group||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking Description:||Family participants are masked and control group is not aware of the intervention condition. PHN participants are not masked.|
|Primary Purpose:||Health Services Research|
|Official Title:||Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children|
|Actual Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
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.
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.
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.
- 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).
- 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).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278288
|Contact: Anni Pakarinen, MHScemail@example.com|
|Child health clinics||Recruiting|
|Four Municipalities, Southwest Finland, Finland|
|Contact: Anni Pakarinen +358451213567 firstname.lastname@example.org|
|Principal Investigator:||Anni Pakarinen, MHSc||University of Turku, Finland|