NCT06163638

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

November 8, 2022

Last Update Submit

July 4, 2024

Conditions

Keywords

IntergenerationalGrandparentsGrandchildrenPhysical activityCognitive functioningHealth promotionCo-creation

Outcome Measures

Primary Outcomes (2)

  • Change in co-PA in grandchildren and grandparents

    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

    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 Outcomes (9)

  • Change in general well-being in children

    During 3 months, every 2 weeks

  • Change in quality of the family relationship in children

    3 months, pre, between, post intervention

  • Change in general well-being in grandparents

    During 3 months, every 2 weeks

  • Change in quality of the family relationship in grandparents

    3 months, pre, between, post intervention

  • Change in cognitive functioning in grandchildren

    During 3 months, every 2 weeks

  • +4 more secondary outcomes

Study Arms (1)

Intergenerational movement program

EXPERIMENTAL

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

Interventions

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)

Intergenerational movement program

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 6 and 10 years old
  • Having at least 1 grandparent
  • Speaking Dutch
  • No serious physical, cognitive or psychiatric health problems
  • Having at least 1 grandchild (aged between 6 and 10 years old)
  • Speaking Dutch
  • No serious physical, cognitive or psychiatric health problems

You may not qualify if:

  • \- Having medical health problems (epilepsy) that can cause a risk when participating in the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cardon

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: We will work with a single-case design (ABAB), where all participants will receive the intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 11, 2023

Study Start

September 19, 2022

Primary Completion

April 19, 2023

Study Completion

June 20, 2023

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations