Intergenerational Relations Clinical Trial
— GRANDPACTOfficial title:
The Development and Evaluation of an Intergenerational Program for GRANDchildren and Their GRANDparents to Stimulate Physical Activity and Cognitive Function Using Co-creaTion
Verified date | May 2024 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
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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