Adults Aged 50 Years and OlderNCT04307589
The Impact of Grandchild Care on Physical Activity and Sedentary Behavior in People Aged 50 Years and Over
An observational study of Adults Aged 50 Years and Older, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
Given the widespread provision of grandparental child care, examining its impact on grandparents' energy-expenditure related behaviors in the broader context of health is imperative. The maintenance of functional independence and good quality of life is critical at a more advanced age. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adults Aged 50 Years and Older
- What is being tested?
- Observation
- How many people
- 255 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People aged 50 years and over with and without grandchildren.
Who may be able to join
- Being ≥50 years of age
- Speaking the Dutch language
- Being able to perform independent locomotion (e.g. not relying on a walking aid or wheelchair, etc.)
- Not suffering from a known cognitive impairment affecting one's memory, attention or understanding (e.g. dementia, brain injury, etc.)
- Not living in a residential care center for elderly people
Who cannot join
- Being <50 years of age
- Not speaking the Dutch language
- Not being able to perform independent locomotion (e.g. relying on a walking aid or wheelchair, etc.)
- Suffering from a known cognitive impairment affecting one's memory, attention or understanding (e.g. dementia, brain injury, etc.)
- Living in a residential care center for elderly people
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Grandparenting: The Impact of Non-residential Grandchild Care on Physical Activity and Sedentary Behavior in People Aged 50 Years and Over
Given the widespread provision of grandparental child care, examining its impact on grandparents' energy-expenditure related behaviors in the broader context of health is imperative. The maintenance of functional independence and good quality of life is critical at a more advanced age. It has been put forward that an increased duration, frequency and intensity of physical activity (PA) combined with a restriction of sedentary behavior (SB) is the most important strategy to reduce morbidity risk and to foster health in an aging population. The present study aims to fill a gap in current knowledge on (changes in) caregiving grandparents' PA levels and SB patterns. An observational follow-up study will be conducted to examine and compare both energy-expenditure related behaviors linked to body composition and health-related quality of life among caregiving grandparents, non-caregiving grandparents and non-grandparent peers, both momentarily and over time. This fundamental research aims to provide scientific evidence contributing to the promotion of healthy grandparenting in people on the threshold of old age in modern society.
Read the detailed description
The first objective of the study is to provide a detailed overview of habitual levels of physical activity and sedentary behavior among caregiving grandparents in relation to their body composition and health-related quality of life (including both physical and mental function), and to identify to what extent these outcome measures are associated with the number, sex and age of the grandchild(ren) as well as with the intensity of grandparents' provision of child care, while taking some demographic characteristics of the grandparent (i.e., age, sex, marital status, socio-economic status (SES)) into account.
The second objective is to compare caregiving grandparents' energy-expenditure related behaviors (i.e., physical activity and sedentary behavior) and their link with health-related measures of interest (i.e., body composition and quality of life) with both non-caregiving grandparents and non-grandparent peers as relevant control groups.
The third objective is to investigate (age-related) changes in physical activity and sedentary behavior linked to body composition and health-related quality of life among caregiving grandparents versus non-caregiving grandparents as well as non-grandparents both in the short and the longer term, and to identify possible predictors of these changes over time. Additionally, it is the intention to examine the impact of middle-aged and older adults making the transition to (caregiving) grandparenthood on both energy-expenditure related behaviors as well as the health-related measures of interest.
- Conditions
- Adults Aged 50 Years and Older
- Being tested
- Observation
- Keywords
- grandparents, grandchildren, caregiving, physical activity, sedentary behavior, body composition, quality of life, prospective cohort study
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
An observational follow-up study will be implemented over a period of 2 years, consisting of 3 test occasions with a fixed time interval of 1 year in between (T0 = baseline, T1 = 12 months, T2 = 24 months). Data will be collected in participants who provide grandchild care in a non-residential grandparent context as well as in a sample of non-caregiving grandparents and a sample of middle-aged and older adults not being a grandparent. All three samples will thus be prospectively monitored over a period of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Caregiving grandparents | Not described Receives: Other: Observation | |
| Non-caregiving grandparents | Not described Receives: Other: Observation | |
| Middle-aged and older adults not being a grandparent | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Physical activity will be assessed subjectively by using a self-reported questionnaire (International Physical Activity Questionnaire (IPAQ - Dutch version)) and objectively by using a tri-axial accelerometers (Actigraph, wGT3X-BT) over a one-week period.
Measured: At baseline (T0), at 12 months (T1), at 24 months (T2)
Change in sedentary behavior
Sedentary behavior will be assessed subjectively by using a self-reported questionnaire (Sedentary Behavior Questionnaire for (older) adults in Dutch) and objectively by using a tri-axial accelerometers (Actigraph, wGT3X-BT) over a one-week period.
Measured: At baseline (T0), at 12 months (T1), at 24 months (T2)
Secondary outcomes (3)
Change in body dimensions
Body height measured by means of mobile equipment (SECA 213). Body weight measured by means of mobile equipment (TANITA MC-780 SM A). Waist and hip circumferences will be measured by means of Cescorf measuring tape.
Measured: At baseline (T0), at 12 months (T1), at 2 year months (T2)
Change in body composition
Body composition will be measured by bio-electrical impedance analysis (BIA, TANITA MC-780 S MA) to estimate fat mass, fat free mass and muscle mass.
Measured: At baseline (T0), at 12 months (T1), at 2 year months (T2)
Change in quality of life: self-reported questionnaire
Quality of life will be measured subjectively by using a self-reported questionnaire (Multipurpose 36-item Short-Form Health Survey version 2.0 (SF-36v2) (Dutch version)).
Measured: At baseline (T0), at 12 months (T1), at 24 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Sep 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults Aged 50 Years and OlderStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, University Ghent
- Responsible party
- Principal investigator, Marie Vermote, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307589
- Sponsor's protocol ID
- 2020-067
- Status last verified
- Apr 2023
- First submitted
- 10 Mar 2020
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Grandparenting: The Impact of Non-residential Grandchild Care on Physical Activity and Sedentary Behavior in People Aged 50 Years and Over
- ClinicalTrials.gov ID
- NCT04307589
- Acronym / sponsor ID
- 2020-067
- Conditions
- Adults Aged 50 Years and Older
- Keywords
- grandparents, grandchildren, caregiving, physical activity, sedentary behavior, body composition, quality of life, prospective cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, University Ghent
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the widespread provision of grandparental child care, examining its impact on grandparents' energy-expenditure related behaviors in the broader context of health is imperative. The maintenance of functional independence and good quality of life is critical at a more advanced age. It has been put forward that an increased duration, frequency and intensity of physical activity (PA) combined with a restriction of sedentary behavior (SB) is the most important strategy to reduce morbidity risk and to foster health in an aging population. The present study aims to fill a gap in current knowledge on (changes in) caregiving grandparents' PA levels and SB patterns. An observational follow-up study will be conducted to examine and compare both energy-expenditure related behaviors linked to body composition and health-related quality of life among caregiving grandparents, non-caregiving grandparents and non-grandparent peers, both momentarily and over time. This fundamental research aims to provide scientific evidence contributing to the promotion of healthy grandparenting in people on the threshold of old age in modern society.
Detailed description
The first objective of the study is to provide a detailed overview of habitual levels of physical activity and sedentary behavior among caregiving grandparents in relation to their body composition and health-related quality of life (including both physical and mental function), and to identify to what extent these outcome measures are associated with the number, sex and age of the grandchild(ren) as well as with the intensity of grandparents' provision of child care, while taking some demographic characteristics of the grandparent (i.e., age, sex, marital status, socio-economic status (SES)) into account.
The second objective is to compare caregiving grandparents' energy-expenditure related behaviors (i.e., physical activity and sedentary behavior) and their link with health-related measures of interest (i.e., body composition and quality of life) with both non-caregiving grandparents and non-grandparent peers as relevant control groups.
The third objective is to investigate (age-related) changes in physical activity and sedentary behavior linked to body composition and health-related quality of life among caregiving grandparents versus non-caregiving grandparents as well as non-grandparents both in the short and the longer term, and to identify possible predictors of these changes over time. Additionally, it is the intention to examine the impact of middle-aged and older adults making the transition to (caregiving) grandparenthood on both energy-expenditure related behaviors as well as the health-related measures of interest.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caregiving grandparents | – | Other: Observation |
| Non-caregiving grandparents | – | Other: Observation |
| Middle-aged and older adults not being a grandparent | – | Other: Observation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People aged 50 years and over with and without grandchildren.
Key inclusion criteria (5 listed)
- Being ≥50 years of age
- Speaking the Dutch language
- Being able to perform independent locomotion (e.g. not relying on a walking aid or wheelchair, etc.)
- Not suffering from a known cognitive impairment affecting one's memory, attention or understanding (e.g. dementia, brain injury, etc.)
- Not living in a residential care center for elderly people
Key exclusion criteria (5 listed)
- Being <50 years of age
- Not speaking the Dutch language
- Not being able to perform independent locomotion (e.g. relying on a walking aid or wheelchair, etc.)
- Suffering from a known cognitive impairment affecting one's memory, attention or understanding (e.g. dementia, brain injury, etc.)
- Living in a residential care center for elderly people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationAn observational follow-up study will be implemented over a period of 2 years, consisting of 3 test occasions with a fixed time interval of 1 year in between (T0 = baseline, T1 = 12 months, T2 = 24 months). Data will be collected in participants who provide grandchild care in a non-residential grandparent context as well as in a sample of non-caregiving grandparents and a sample of middle-aged and older adults not being a grandparent. All three samples will thus be prospectively monitored over a period of 2 years. | Other | Caregiving grandparents, Middle-aged and older adults not being a grandparent, Non-caregiving grandparents |
Primary outcome
Change in physical activity
Time frame: At baseline (T0), at 12 months (T1), at 24 months (T2)
Physical activity will be assessed subjectively by using a self-reported questionnaire (International Physical Activity Questionnaire (IPAQ - Dutch version)) and objectively by using a tri-axial accelerometers (Actigraph, wGT3X-BT) over a one-week period.
Change in sedentary behavior
Time frame: At baseline (T0), at 12 months (T1), at 24 months (T2)
Sedentary behavior will be assessed subjectively by using a self-reported questionnaire (Sedentary Behavior Questionnaire for (older) adults in Dutch) and objectively by using a tri-axial accelerometers (Actigraph, wGT3X-BT) over a one-week period.
3 secondary outcomes
Change in body dimensions
Time frame: At baseline (T0), at 12 months (T1), at 2 year months (T2)
Change in body composition
Time frame: At baseline (T0), at 12 months (T1), at 2 year months (T2)
Change in quality of life: self-reported questionnaire
Time frame: At baseline (T0), at 12 months (T1), at 24 months (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults Aged 50 Years and Older, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity (time frame: At baseline (T0), at 12 months (T1), at 24 months (T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.