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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06163638
Other study ID # GRANDPACT Project - BC-11748
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 19, 2022
Est. completion date December 25, 2024

Study information

Verified date May 2024
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date December 25, 2024
Est. primary completion date March 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
GRANDPACT Project
To investigate whether grandparents and grandchildren are more co-physically active, have a better cognitive function, psychosocial well-being, quality of the family relationship and expectations regarding aging and motor competence due to the intervention, 2 arms were created to test the effets.

Locations

Country Name City State
Belgium Ghent University Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (ActiGraph wGT3X-BT) during 8 consecutive days. The purpose of wearing an accelerometer is to investigate whether grandchildren and their grandparents are more (co-)physically active together after the intervention. 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Primary 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 (ActiGraph wGT3X-BT) by measuring heart rate. 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in psychosocial well-being in children The 23-item Pediatric health-related Quality of Life scale (PEDs-QL) will be used to have a reliable and valid global assessment of children's general quality of life and their specific emotional, social and school functioning. Every item is scored on 4 (1, 2, 3 or 4) and higher scores mean a worse outcome (worse psychosocial well-being). The minimum score is 23 on 92, the maximum score is 92 on 92. 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in quality of the family relationship in children Interview with children based on the Grandparent-grandchild Relationship Questionnaire (children's literacy is too limited to complete the questionnaire) 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in quality of the family relationship in children Interview with children based on Rey and Ruiz's Socialization Styles Questionnaire (children's literacy is too limited to complete the questionnaire) 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in expectations regarding aging in children The Young Children's Views of Older People (YCVOP) scale will be used to mesarure expectations regarding aging. Two pairs of adjectives (e.g., strong - weak) are showed with a Visual Analogue Scale in between to put a mark on it. The final position of the mark will generate a score (value present at the back of the VAS and not seen by the child) for each pair of adjectives ranging from -50 (extremely negative) to +50 (extremely positive). We will calculate a mean global score, also comprised between -50 and +50 (neutral score at 0), for each child. Higher scores on the YCVOP indicate more positive views of older people. 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in psychosocial well-being in grandparents To capture a wide conception of older adults' psychological well-being including af-fective-emotional aspects, cognitive-evaluative dimensions and psychological functioning the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) will be used. The 14 items are scored from 1 to 5 and higher scores mean a higher well-being. The minimum score is 14 on 70, the maximum score is 70 on 70. 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in psychosocial well-being in grandparents Social isolation (defined as the way in which older adults perceive, experience, and evaluate isolation and lack of communication with others) will be measured using the valid and reliable Social and Emotional Loneliness scale for Adults (SELSA). The scale is comprised of three subscales of 12, 11, and 14 items, respectively, which are responded to on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores mean less social isolation. The minimum score is 37 on 259, the maximum score is 259 on 259. 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in quality of the family relationship in grandparents Moving from literature and previous investigations (Battistelli & Farneti, 1991; Farneti & Battistelli, 2003) a new self-report questionnaire, of 26 items was used. This questionnaire, assessed grandparents' opinion concerning their relationship with grandchildren using 3 subscales:
feelings and emotions towards grandchildren (7 items);
grandparents and grandchildren shared activities a) symbolic activities based on language (telling fairy tales or family history stories), b) activities based on technology (like watching TV, playing on the computer) and c) sport and physical activities (for instance walking) (9 items);
attitudes regarding grandparents role as well as children's educational behaviour (10 items).
After reading each statements, grandparents had to rate their accordance on the Likert-scale with eleven positions (0=totally not agree; 10=totally agree). The minimum score is 0 on 260, the maximum score is 260 on 260.
9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in expectations regarding aging in grandparents In grandparents, the ERA-38 will be used. The scale focuses on 10 dimensions related to aging (General health, Cognitive function, Mental health, Functional independence, Sexual function, Pain, Urinary incontinence, Sleep, Fatigue, Appearance) and is divided into two sections : (1) What the participant expects for themselves about aging and (2) The participant's expectations for aging in older people in general. Questions for both sections are based on a 4-item scale (ranging from 1 to 4; Definitely True, Somewhat True, Somewhat False, and Definitely False). Possible scores can range from 0 to 100; a higher score is considered to be consistent with Rowe & Kahn's (1987) model of successful aging, whereas a low score is associated with health decline and function. 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
Secondary Change in cognitive functioning in grandchildren and grandparents To objectively measure cognitive functioning, participants (grandparents and grandchildren) will be asked to complete tests on an iPad using the Cambridge Neurological Test Automated Battery (CANTAB). The specific tests are yet to be determined. 9 months (pre: at baseline, post: after 6 weeks, follow-up: after 18 weeks)
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