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Father-Child RelationsRDRNCT04590755

Run Daddy Run! A Lifestyle Intervention Focusing on Fathers and Their Children

A study testing Interactive father-child sessions and website in people with Father-Child Relations, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Father-Child Relations
What is being tested?
Interactive father-child sessions and website
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteBelgium
Study dates
1 Oct 2019to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Fathers
  • Primary school aged children

Who cannot join

  • Unhealthy/disease

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University

    Ghent, 9000

Other trials in Belgium

About this study

Official title: Run, Daddy, Run! A Multicomponent eHealth Lifestyle Intervention for the Prevention of Overweight and Obesity: Engaging Fathers and Their Children

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.

Read the detailed description

The Run Daddy Run project aims to develop an effective lifestyle intervention for Belgian fathers and their primary school-aged children, to prevent overweight and obesity. There is focused on increasing (co-) physical activity and limiting individual and joint screen time. The project specifically targets fathers and their children because the literature shows that now often only mothers participate in lifestyle interventions, and fathers are underrepresented and difficult to involve. However, fathers play an important and unique role, independently of the mother, in shaping the child's behavior.

The Run Daddy Run intervention was developed based on the Intervention Mapping Protocol, a theoretical framework that is often used to develop interventions in a systematic way using empirical evidence and theoretical insights. A co-creation approach was also used for the intervention development, which is a bottom-up approach in which the target group (fathers in this case) is actively involved in the development of the intervention. The result of this approach is contextually appropriate intervention and intervention strategies.

Being tested
Interactive father-child sessions and website
Keywords
Obesity, Fathers, Children, Primary school, Intervention, Physical activity, Screen time, Sedentary Behaviour
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive father-child sessions and websiteBehavioural

    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.

Study groups in NCT04590755
Study groupRoleWhat they receive
Interactive father-child sessions and use of websiteExperimentalIntervention group will receive the Run Daddy Run intervention.
Receives: Behavioral: Interactive father-child sessions and website
No intervention (no interactive father-child sessions and use of website)No interventionIntervention group will not receive the Run Daddy Run intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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].

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

  2. 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].

    Measured: 8 months (post-test)

  3. 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].

    Measured: 8 months (post-test)

Secondary outcomes (7)

  1. Change in co-screen time

    Co-ST will be 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].

    Measured: 8 months (post-test)

  2. Change in Sedentary behaviour (including screen time) father

    For measuring SB of the father, objective data will also be collected through accelerometry described under "Physical activity" measurements. Participants' SB will be assessed during a 7 days period using Axivity's, which have been shown to be a reliable and valid measure for SB. Additionally, SB (including ST) will be assessed using the International Sedentary Assessment Tool (ISAT) questionnaire [64]. This questionnaire has a good internal consistency (reliability) (Cronbach Alpha=0.80) and good criterion validity (interclass correlation r=0.63) [65]. In the ISAT, SB is questioned on week- and weekend days, as well as specific ST-related behaviours are questioned (i.e. TV/DVD viewing, computer/laptop/PlayStation use and smartphone/tablet use). The mean daily SB and ST of the fathers and their children will be calculated using the following formula: (SG or ST weekdays × 5 + SG or ST weekend days × 2) / 7.

    Measured: 8 months (post-test)

  3. Change in Sedentary behaviour (including screen time) child

    For measuring SB of the child, objective data will also be collected through accelerometry described under "Physical activity" measurements. Participants' SB will be assessed during a 7 days period using Axivity's, which have been shown to be a reliable and valid measure for SB. Additionally, SB (including ST) will be assessed using the International Sedentary Assessment Tool (ISAT) questionnaire [64]. This questionnaire has a good internal consistency (reliability) (Cronbach Alpha=0.80) and good criterion validity (interclass correlation r=0.63) [65]. In the ISAT, SB is questioned on week- and weekend days, as well as specific ST-related behaviours are questioned (i.e. TV/DVD viewing, computer/laptop/PlayStation use and smartphone/tablet use). The mean daily SB and ST of the fathers and their children will be calculated using the following formula: (SG or ST weekdays × 5 + SG or ST weekend days × 2) / 7.

    Measured: 8 months (post-test)

  4. Change in Father-child relationship (quality of relationship)

    Quality of the relationship between the father and the child will be measured with the Nurturant Fathering scale (NFS) [69]. This scale is a valid and reliable measure to characterize the relationship between the father and the child [70-72]. It consists of 9 items, each rated on a 5-point scale, and possible scores on this measure range from 9 to 45. Higher scores mean a better relationship.

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

  5. Change in psychosocial determinants (co)PA

    The following determinants were questioned: (1) knowledge regarding the PA norm for both adults and (2) children, (3) knowledge and (4) self-efficacy towards motivating child for PA, (5) knowledge regarding limiting ST and (6) interrupting SB, (7) attitude towards limiting ST, (8) attitude towards and (9) importance of co-PA, (10) self-efficacy towards increasing co-PA, (11) degree of experienced barriers towards co-PA, (12) social support towards co-PA and (13) habits towards co-PA. For determinants on knowledge, participants were asked to estimate the norm (in minutes). The deviation from the norm was then calculated, with the value 0 representing a correct estimate of the norm and the higher the score deviating from 0, the greater the deviation from the correct answer. The other determinants were questioned and rated on a numerical response scale (values between 0 and 100, with 0 as the lowest score and 100 as the highest score).

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

  6. Change in Family Health Climate

    The family context regarding PA will be questioned using the Family Health Climate Scale (FHC-PA) [68]. The family health climate can be seen as a determinant of person's health behaviour, and is defined as shared perceptions and cognitions concerning a healthy lifestyle within a family, and represents a family level variable that is intra- and inter-individually correlated to family environmental and individual factors. The FHC-PA is a validated questionnaire containing three subscales: value, cohesion and information on PA in the family. In total, this questionnaire contains 14 items, where participants can score these items on a 4-point Likert scale ranging from 1 "definitely false" to 4 "definitely true". The total score is the sum of all individual items scores, ranging from 14 to 56. Higher scores mean a better family health climate.

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

  7. Change in Parental Practices regarding PA

    Parental skills and practices towards PA will be questioned in 16 questions, derived from four valid and reliable questionnaires each measuring specific parenting practices and skills [73-77].

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start1 Oct 2019
  3. Primary completion1 Jun 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-Randomized Controlled Trial with Intervention and Control Group
Masking
Single blind
Who is masked
Participant
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04590755
Sponsor's protocol ID
FWO17/ASP/123
Acronym
RDR
Status last verified
Sep 2020
First submitted
9 Sep 2020
Last updated
29 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36793044

  • 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.

    PubMed 33668562

Questions about this trial

What is this clinical trial studying?

A study testing Interactive father-child sessions and website in people with Father-Child Relations, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in co-physical Activity (time frame: 8 months (post-test), 14 months (follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04590755, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.

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