NCT04307589

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

March 10, 2020

Last Update Submit

April 27, 2023

Conditions

Keywords

grandparentsgrandchildrencaregivingphysical activitysedentary behaviorbody compositionquality of lifeprospective cohort study

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (3)

  • Change in body dimensions

    At baseline (T0), at 12 months (T1), at 2 year months (T2)

  • Change in body composition

    At baseline (T0), at 12 months (T1), at 2 year months (T2)

  • Change in quality of life: self-reported questionnaire

    At baseline (T0), at 12 months (T1), at 24 months (T2)

Other Outcomes (2)

  • Intensity of non-residential grandchild care

    At baseline (T0), at 12 months (T1), at 24 months (T2)

  • Socio-demographic characteristics

    At baseline (T0), at 12 months (T1), at 24 months (T2)

Study Arms (3)

Caregiving grandparents

Other: Observation

Non-caregiving grandparents

Other: Observation

Middle-aged and older adults not being a grandparent

Other: Observation

Interventions

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.

Caregiving grandparentsMiddle-aged and older adults not being a grandparentNon-caregiving grandparents

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People aged 50 years and over with and without grandchildren.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Belgium

Location

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 13, 2020

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 1, 2023

Record last verified: 2023-04

Locations