- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06163638
The Development of an Intergenerational Movement Program for Grandchildren and Their Grandparents Using Co-creation (GRANDPACT)
The Development and Evaluation of an Intergenerational Program for GRANDchildren and Their GRANDparents to Stimulate Physical Activity and Cognitive Function Using Co-creaTion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ghent, Belgium, 9000
- Ghent University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for children:
- Aged between 6 and 10 years old
- Having at least 1 grandparent
- Speaking Dutch
- No serious physical, cognitive or psychiatric health problems
Inclusion Criteria for grandparents:
- Having at least 1 grandchild (aged between 6 and 10 years old)
- Speaking Dutch
- No serious physical, cognitive or psychiatric health problems
Exclusion Criteria grandparents:
- Having medical health problems (epilepsy) that can cause a risk when participating in the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intergenerational movement program
This group will receive the intergenerational physical activity program.
There are 4 components, which consist of an educational session for grandparents and parents (1), group-based movement sessions for grandparents and grandchildren once a week during 8 weeks (2), home-based physical activities for both grandparents and grandchildren (3) and community-based activities for both grandparents and grandchildren (4).
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To investigate whether grandparents and grandchildren are more co-physically active, have a better cognitive and physical function, psychosocial well-being, quality of the family relationship due to the intervention, we compare the intervention phase (B) with a pre phase (A), a in between period (A) and another intervention period (B)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in co-PA in grandchildren and grandparents
Time Frame: 3 months (A: 2 weeks, B: 6 weeks, A: 2 weeks, B: 2 weeks)
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The primary outcome of the intervention is co-PA.
To objectively measure co-PA, participants will be asked to wear an accelerometer (Axivity AX3) during three consecutive months.
The purpose of wearing an accelerometer is to investigate whether grandchildren and their grandparents are more (co-)physically active when the intervention is adopted
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3 months (A: 2 weeks, B: 6 weeks, A: 2 weeks, B: 2 weeks)
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Change in intensity of PA in grandchildren and grandparents
Time Frame: 3 months (A: 2 weeks, B: 6 weeks, A: 2 weeks, B: 2 weeks)
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In addition to the primary outcome of the intervention, which is co-PA, we would like to measure the intensity of PA during each movement session with an accelerometer (Axivity AX3)
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3 months (A: 2 weeks, B: 6 weeks, A: 2 weeks, B: 2 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in general well-being in children
Time Frame: During 3 months, every 2 weeks
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PedsQL 8-12 General Well-Being Scale Parent report
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During 3 months, every 2 weeks
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Change in quality of the family relationship in children
Time Frame: 3 months, pre, between, post intervention
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Interview with parents before, during and after the intervention period
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3 months, pre, between, post intervention
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Change in general well-being in grandparents
Time Frame: During 3 months, every 2 weeks
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Warwick-Edinburgh Mental Wellbeing Scale (WEMWS) - 14 items - 5-point likert scale (never, seldom, sometimes, often, always), with higher scores resulting in a higher wellbeing.
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During 3 months, every 2 weeks
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Change in quality of the family relationship in grandparents
Time Frame: 3 months, pre, between, post intervention
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Interview with grandparents pre, during and after the intervention
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3 months, pre, between, post intervention
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Change in cognitive functioning in grandchildren
Time Frame: During 3 months, every 2 weeks
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Parents will fill in the short forms of the PROMIS cognitive functioning. Grandchildren: 7-items on a 5-point likert scale (never, seldom, sometimes, often, always), with higher scores resulting in a better cognitive functioning |
During 3 months, every 2 weeks
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Change in cognitive functioning in grandparents
Time Frame: During 3 months, every 2 weeks
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Grandparents will fill in the short forms of the PROMIS cognitive functioning. Grandparents: 8-items on a 5-point likert scale (never, seldom, sometimes, often, always), with higher scores resulting in a better cognitive functioning |
During 3 months, every 2 weeks
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Change in physical functioning in grandparents
Time Frame: During 3 months, every 2 weeks
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Grandparents will fill in the short forms of the PROMIS physical functioning. Grandparents: 10-items on a 5-point likert scale (Without any effort, With a little effort, With some effort, With a lot of effort, Unable to do), with higher scores resulting in a better physical functioning |
During 3 months, every 2 weeks
|
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Change in physical functioning in grandchildren
Time Frame: During 3 months, every 2 weeks
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Parents will fill in the short forms of the PROMIS physical functioning. Grandchildren: 7-items on a 5-point likert scale (Without any effort, With a little effort, With some effort, With a lot of effort, Unable to do), with higher scores resulting in a better physical functioning |
During 3 months, every 2 weeks
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Increasing WHO themes in grandparents
Time Frame: During 3 months, every 2 weeks
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We ask grandparents if they did exercises focusing on condition, coordination, strength, balance and flexibility
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During 3 months, every 2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cardon, University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GRANDPACT Project - BC-11748
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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