The Development of an Intergenerational Movement Program for Grandchildren and Their Grandparents Using Co-creation (GRANDPACT)

July 4, 2024 updated by: University Ghent

The Development and Evaluation of an Intergenerational Program for GRANDchildren and Their GRANDparents to Stimulate Physical Activity and Cognitive Function Using Co-creaTion

The aim of this study is to develop, evaluate and implement an intergenerational physical activity program for grandchildren and their grandparents using co-creation focusing on the promotion of (co-)physical activity as a primary outcome and cognitive functioning, psychosocial well-being, the family relationship, expectations regarding aging and motor competence in grandparents and grandchildren as secondary outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In recent years, increased attention has been devoted to intergenerational physical activity (PA) programs because they may have several benefits for children and older adults (e.g., learning skills from each other, reduction of ageism). An intergenerational PA program focusing on grandchildren and -parents in a 'standard' family setting and the combination of PA and cognitive functions is innovative and may hold potential to promote PA and improve cognitive functions in both grandchildren and their grandparents. The aim of this study is to describe the protocol of the GRANDPACT (GRANDparents and GRANDchildren improve their Physical Activity and Cognitive functions using co-creaTion) project, focusing on the development of an intergenerational PA program for grandchildren and -parents using the theoretical framework "Behaviour Change Wheel" in combination with a co-creation approach. One co-creation trajectory will be organized to develop the program, followed by an efficacy trial to refine and evaluate the program with measurements pre (at baseline), post (after 24 weeks) and follow-up (after 36 weeks) to measure the outcomes of (co-)PA, cognitive functions, psychosocial well-being, the quality of the family relationship, expectations regarding aging and motor competence in grandchildren and -parents. The outcomes will be measured using accelerometery for PA, Cambridge Neuropsychological Test Automated Battery (CANTAB) testing for cognitive functions and questionnaires for psychosocial well-being, quality of the family relationship and expectations regarding aging. Motor competence will be tested with different field tests in grandparents and grandchildren. Co-development with end-users and stakeholders during the co-creation trajectory is expected to result in an effective, attractive and feasible program. Co-PA is expected to improve PA, cognitive functions, psychosocial well-being, quality of the family relationship, motor competence and motivation to be physically active in grandchildren and -parents. Both will also have better expectations regarding aging.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: GRANDPACT Project
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in co-PA in grandchildren and grandparents
Time Frame: 3 months (A: 2 weeks, B: 6 weeks, A: 2 weeks, B: 2 weeks)
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
3 months (A: 2 weeks, B: 6 weeks, A: 2 weeks, B: 2 weeks)
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)
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)
3 months (A: 2 weeks, B: 6 weeks, A: 2 weeks, B: 2 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in general well-being in children
Time Frame: During 3 months, every 2 weeks
PedsQL 8-12 General Well-Being Scale Parent report
During 3 months, every 2 weeks
Change in quality of the family relationship in children
Time Frame: 3 months, pre, between, post intervention
Interview with parents before, during and after the intervention period
3 months, pre, between, post intervention
Change in general well-being in grandparents
Time Frame: During 3 months, every 2 weeks
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.
During 3 months, every 2 weeks
Change in quality of the family relationship in grandparents
Time Frame: 3 months, pre, between, post intervention
Interview with grandparents pre, during and after the intervention
3 months, pre, between, post intervention
Change in cognitive functioning in grandchildren
Time Frame: During 3 months, every 2 weeks

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
Change in cognitive functioning in grandparents
Time Frame: During 3 months, every 2 weeks

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
Change in physical functioning in grandparents
Time Frame: During 3 months, every 2 weeks

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
Change in physical functioning in grandchildren
Time Frame: During 3 months, every 2 weeks

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
Increasing WHO themes in grandparents
Time Frame: During 3 months, every 2 weeks
We ask grandparents if they did exercises focusing on condition, coordination, strength, balance and flexibility
During 3 months, every 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cardon, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GRANDPACT Project - BC-11748

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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