<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278288</url>
  </required_header>
  <id_info>
    <org_study_id>WellWeF2017</org_study_id>
    <nct_id>NCT03278288</nct_id>
  </id_info>
  <brief_title>Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children</brief_title>
  <official_title>Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turku</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the effectiveness of the WellWe-intervention in promotion of parental&#xD;
      self-efficacy for healthy behaviors and mindfulness in parenting from the perspective of&#xD;
      families. Aim is also to evaluate the effectiveness of the WellWe-intervention in&#xD;
      facilitation of family-centered approach of the health visit in Child health clinic perceived&#xD;
      by the families and Public health nurses (PHN). Half of the participants will receive&#xD;
      WellWe-intervention and half of the participants will receive usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Families with pre-school aged children attend to regular health visits in Child health&#xD;
      clinics on a yearly basis. During the health visits PHNs assess and promote the health and&#xD;
      wellbeing of the whole family through health discussions.&#xD;
&#xD;
      In this study we aim to evaluate whether the addition of gamified method into the health&#xD;
      discussion promotes healthy behaviors and mindfulness of the families and increases the&#xD;
      family-centered approach of health visit compared to the traditional method.&#xD;
&#xD;
      WellWe-intervention includes the use of gamified WellWe app at home and during the health&#xD;
      discussion in the Child health clinic. Usual care includes paper-based questionnaires filled&#xD;
      by the parents and health discussion using these questionnaires in the Child health clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Family participants are masked and control group is not aware of the intervention condition. PHN participants are not masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Parental Self-Efficacy for Healthy Dietary and Physical Activity Behaviors in Preschoolers Scale (PDAP)</measure>
    <time_frame>at baseline, an average of 2 weeks and an average of 4 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Mindfulness In Parenting Questionnaire (MIPQ)</measure>
    <time_frame>at baseline and an average of 4 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on the family-centered approach of the health visit</measure>
    <time_frame>an average of 2 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Questionnaire on the background information on the family</measure>
    <time_frame>at baseline</time_frame>
    <description>Questionnaire developed for the study purposes includes questions of the respondent's gender, age, education, occupation, family circumstances.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Health Behavior</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>WellWe-Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WellWe-Intervention group</intervention_name>
    <description>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.</description>
    <arm_group_label>WellWe-Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  families: Finnish speaking families with 4-year old child and attend into health visit&#xD;
             in Child health clinic during data collection period.&#xD;
&#xD;
          -  PHNs: a permanent employee in Child health clinic or deputy employee working in Child&#xD;
             health clinic during the data collection period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  families: Child is developmentally disabled to participate to the use of WellWe-app&#xD;
             with parents.&#xD;
&#xD;
          -  PHNs: Deputy employees working in Child health clinic only a short period of time or&#xD;
             temporarily.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anni Pakarinen, MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turku, Finland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anni Pakarinen, MHSc</last_name>
    <phone>+358451213567</phone>
    <email>anni.pakarinen@utu.fi</email>
  </overall_contact>
  <location>
    <facility>
      <name>Child health clinics</name>
      <address>
        <city>Four Municipalities</city>
        <state>Southwest Finland</state>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anni Pakarinen</last_name>
      <phone>+358451213567</phone>
      <email>anni.pakarinen@utu.fi</email>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turku</investigator_affiliation>
    <investigator_full_name>Anni Pakarinen</investigator_full_name>
    <investigator_title>Doctoral candidate</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278288
org study id: WellWeF2017
nct id: NCT03278288
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Health Services Research
masking: Single (Participant)
masking description: Family participants are masked and control group is not aware of the intervention condition. PHN participants are not masked.
measure: 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
description: 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).
measure: Change in Mindfulness In Parenting Questionnaire (MIPQ)
time frame: at baseline and an average of 4 months
description: 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).
measure: Questionnaire on the family-centered approach of the health visit
time frame: an average of 2 weeks
description: 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.
measure: Questionnaire on the background information on the family
time frame: at baseline
description: Questionnaire developed for the study purposes includes questions of the respondent's gender, age, education, occupation, family circumstances.
arm group label: WellWe-Intervention group
arm group type: Experimental
description: 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.
arm group label: Usual care group
arm group type: No Intervention
description: 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.
intervention type: Device
intervention name: WellWe-Intervention group
description: 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.
arm group label: WellWe-Intervention group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anni Pakarinen, MHSc
role: Principal Investigator
affiliation: University of Turku, Finland
last name: Anni Pakarinen, MHSc
phone: +358451213567
email: anni.pakarinen@utu.fi
facility: 
status: Recruiting
contact: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Turku
investigator full name: Anni Pakarinen
investigator title: Doctoral candidate