NCT04590755

Brief Summary

The aim of this study is to develop and implement a multicomponent eHealth lifestyle intervention (focusing on (co-) physical activity and screen time) for fathers and their children, aiming to prevent childhood overweight and obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 29, 2021

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 9, 2020

Last Update Submit

January 26, 2021

Conditions

Keywords

ObesityFathersChildrenPrimary schoolInterventionPhysical activityScreen timeSedentary Behaviour

Outcome Measures

Primary Outcomes (3)

  • Change in co-physical Activity

    Father-child co-physical activity, will be subjectively measured using a seven-day recall diary, in which fathers will be asked to report all physical activities and screen time activities they performed together with their child in the last 7 days. More specifically, fathers have to report the start hour of the activity/activities, duration of the activity/activities, and the activity/activities itself in this diary, for each day of the week. PA diaries are often economical and can provide information on the types of activity not recorded from more objective measurement methods, such as accelerometers \[66\]. According to Matthews et al. (2002), diary based self-reported instruments can provide, with good participation compliance, accurate and valid assessments of PA \[67\].

    8 months (post-test), 14 months (follow-up)

  • Change in physical activity father

    Objective PA data will be collected through accelerometry. Axivity's (model AX3, 3-axial) will be worn by the father and the child for at least 7 consecutive days, on the non-dominant hand, for 24 hours a day. Participants' light (LPA), moderate (MPA), vigorous (VPA) and total PA will be assessed during this time period, which have been shown to be reliable and valid \[60\]. As an additional measure of (self-report) PA, fathers will be asked to complete the International Physical Activity Questionnaire Short Form (IPAQ-SF), for both himself and his child, questioning LPA, MPA and VPA during the past seven days \[61, 62\].Research comparing the IPAQ-SF with objective measures (i.e. accelerometers) shows that the criterion validity of this questionnaire is fair to good, with an ICC 0.30 \[62\]. Overall, the IPAQ-SF has reasonable (test-retest) reliability (ICC=0.65) a good internal consistency (Cronbach's Alpha=0.83) \[63\].

    8 months (post-test)

  • Change in physical activity child

    Objective PA data will be collected through accelerometry. Axivity's (model AX3, 3-axial) will be worn by the father and the child for at least 7 consecutive days, on the non-dominant hand, for 24 hours a day. Participants' light (LPA), moderate (MPA), vigorous (VPA) and total PA will be assessed during this time period, which have been shown to be reliable and valid \[60\]. As an additional measure of (self-report) PA, fathers will be asked to complete the International Physical Activity Questionnaire Short Form (IPAQ-SF), for both himself and his child, questioning LPA, MPA and VPA during the past seven days \[61, 62\].Research comparing the IPAQ-SF with objective measures (i.e. accelerometers) shows that the criterion validity of this questionnaire is fair to good, with an ICC 0.30 \[62\]. Overall, the IPAQ-SF has reasonable (test-retest) reliability (ICC=0.65) a good internal consistency (Cronbach's Alpha=0.83) \[63\].

    8 months (post-test)

Secondary Outcomes (7)

  • Change in co-screen time

    8 months (post-test)

  • Change in Sedentary behaviour (including screen time) father

    8 months (post-test)

  • Change in Sedentary behaviour (including screen time) child

    8 months (post-test)

  • Change in Father-child relationship (quality of relationship)

    8 months (post-test), 14 months (follow-up)

  • Change in psychosocial determinants (co)PA

    8 months (post-test), 14 months (follow-up)

  • +2 more secondary outcomes

Study Arms (2)

Interactive father-child sessions and use of website

EXPERIMENTAL

Intervention group will receive the Run Daddy Run intervention.

Behavioral: Interactive father-child sessions and website

No intervention (no interactive father-child sessions and use of website)

NO INTERVENTION

Intervention group will not receive the Run Daddy Run intervention.

Interventions

The Run Daddy Run intervention will consist of 5 (inter)active sessions for fathers and their children + 1 follow-up session, each session lasting 90 minutes. These sessions will be given to 8 groups of +- 13 families (fathers and their children), guided by 2 facilitators and will take place every 2 weeks, at a location in the neighborhood of fathers and children (e.g. school of the children). Additionally, a website will be available for the fathers and their children, with additional information about the project, tips and information about being active together (e.g. movement breaks, fundamental movement skills, etc.) and limiting screen time. In addition, fathers and their children will also log their goals on this website, and between two sessions (= a period of 2 weeks) they will be asked to keep track of their co-PA on this website, aiming to reach their goal.

Interactive father-child sessions and use of website

Eligibility Criteria

Age5 Years - 9 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale: fathers Children: all (both boys and girls)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Fathers
  • Primary school aged children

You may not qualify if:

  • \- Unhealthy/disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Related Publications (2)

  • Latomme J, Morgan PJ, Chastin S, Brondeel R, Cardon G. Effects of a family-based lifestyle intervention on co-physical activity and other health-related outcomes of fathers and their children: the 'Run Daddy Run' intervention. BMC Public Health. 2023 Feb 15;23(1):342. doi: 10.1186/s12889-023-15191-z.

  • Latomme J, Morgan PJ, De Craemer M, Brondeel R, Verloigne M, Cardon G. A Family-Based Lifestyle Intervention Focusing on Fathers and Their Children Using Co-Creation: Study Protocol of the Run Daddy Run Intervention. Int J Environ Res Public Health. 2021 Feb 13;18(4):1830. doi: 10.3390/ijerph18041830.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Greet Cardon

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are allocated to the intervention or control group by the researcher.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Non-Randomized Controlled Trial with Intervention and Control Group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

October 19, 2020

Study Start

October 1, 2019

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

January 29, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations