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

NCT03278288 | Unknown

• 1 other identifier: WellWeF2017
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Mindfulness In Parenting Questionnaire (MIPQ)

  at baseline and an average of 4 months

• Questionnaire on the family-centered approach of the health visit

  an average of 2 weeks

Other Outcomes (1)

• Questionnaire on the background information on the family

  at baseline

Study Arms (2)

WellWe-Intervention group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

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.

Interventions

WellWe-Intervention group DEVICE

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.

WellWe-Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Child health clinics

Four Municipalities, Southwest Finland, Finland

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anni Pakarinen, MHSc

  University of Turku, Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anni Pakarinen, MHSc

CONTACT

+358451213567; anni.pakarinen@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Family participants are masked and control group is not aware of the intervention condition. PHN participants are not masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral candidate

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 11, 2017
• Study Start: May 15, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

FI (1)