- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307589
The Impact of Grandchild Care on Physical Activity and Sedentary Behavior in People Aged 50 Years and Over
Healthy Grandparenting: The Impact of Non-residential Grandchild Care on Physical Activity and Sedentary Behavior in People Aged 50 Years and Over
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussel, Belgium
- Vrije Universiteit Brussel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Caregiving grandparents
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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.
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Non-caregiving grandparents
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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.
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Middle-aged and older adults not being a grandparent
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in physical activity
Time Frame: At baseline (T0), at 12 months (T1), at 24 months (T2)
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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.
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At baseline (T0), at 12 months (T1), at 24 months (T2)
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Change in sedentary behavior
Time Frame: At baseline (T0), at 12 months (T1), at 24 months (T2)
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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.
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At baseline (T0), at 12 months (T1), at 24 months (T2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in body dimensions
Time Frame: At baseline (T0), at 12 months (T1), at 2 year months (T2)
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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.
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At baseline (T0), at 12 months (T1), at 2 year months (T2)
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Change in body composition
Time Frame: At baseline (T0), at 12 months (T1), at 2 year months (T2)
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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.
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At baseline (T0), at 12 months (T1), at 2 year months (T2)
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Change in quality of life: self-reported questionnaire
Time Frame: At baseline (T0), at 12 months (T1), at 24 months (T2)
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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)).
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At baseline (T0), at 12 months (T1), at 24 months (T2)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intensity of non-residential grandchild care
Time Frame: At baseline (T0), at 12 months (T1), at 24 months (T2)
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A self-reported questionnaire (only to be administered in the subsamples of grandparents) will be used to register specific information on the intensity of the non-residential grandchild care they provide in a typical week.
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At baseline (T0), at 12 months (T1), at 24 months (T2)
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Socio-demographic characteristics
Time Frame: At baseline (T0), at 12 months (T1), at 24 months (T2)
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A self-reported questionnaire will be used to collect the necessary demographic information of the participants (i.e., date of birth, sex, marital status, and possible date of retirement), and (if applicable) of their grandchild(ren) (i.e., number of grandchildren, date of birth and the sex of each individual grandchild).
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At baseline (T0), at 12 months (T1), at 24 months (T2)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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