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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04307589
Other study ID # 2020-067
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2023
Source Vrije Universiteit Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Observation
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.

Locations

Country Name City State
Belgium Vrije Universiteit Brussel Brussel

Sponsors (3)

Lead Sponsor Collaborator
Vrije Universiteit Brussel Research Foundation Flanders, University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Intensity of non-residential grandchild care 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. At baseline (T0), at 12 months (T1), at 24 months (T2)
Other Socio-demographic characteristics 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). At baseline (T0), at 12 months (T1), at 24 months (T2)
Primary 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. At baseline (T0), at 12 months (T1), at 24 months (T2)
Primary 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. At baseline (T0), at 12 months (T1), at 24 months (T2)
Secondary 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. At baseline (T0), at 12 months (T1), at 2 year months (T2)
Secondary 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. At baseline (T0), at 12 months (T1), at 2 year months (T2)
Secondary 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)). At baseline (T0), at 12 months (T1), at 24 months (T2)