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

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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
Sponsor:
Information provided by (Responsible Party):
Anni Pakarinen, University of Turku

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.

Condition or disease Intervention/treatment Phase
Health Behavior Healthy Device: WellWe-Intervention group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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: Single (Participant)
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

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.
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278288


Contacts
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Contact: Anni Pakarinen, MHSc +358451213567 anni.pakarinen@utu.fi

Locations
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Finland
Child health clinics Recruiting
Four Municipalities, Southwest Finland, Finland
Contact: Anni Pakarinen    +358451213567    anni.pakarinen@utu.fi   
Sponsors and Collaborators
University of Turku
Investigators
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Principal Investigator: Anni Pakarinen, MHSc University of Turku, Finland
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Responsible Party: Anni Pakarinen, Doctoral candidate, University of Turku
ClinicalTrials.gov Identifier: NCT03278288    
Other Study ID Numbers: WellWeF2017
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No