NCT06467058

Brief Summary

Time-use epidemiology is a rapidly growing research area that aims to understand how individuals allocate their time to various activities throughout the day. Accurate assessment of daily activity behaviors, such as sleep, sedentary behavior (SB), light physical activity (LPA), and moderate to vigorous physical activity (MVPA), is crucial for studying the associations between activity patterns and health outcomes. To gather this information, researchers often rely on self-report questionnaires and objective measures, such as accelerometers, to provide a comprehensive understanding of individuals' activity levels. Recently, a validated questionnaire known as the Daily Activity Behavior Questionnaire (DABQ) has been developed. In a study comparing DABQ estimates with the activPAL4 accelerometer (as the reference method), good results regarding absolute agreement and consistency were obtained for sleep duration (ICC 0.6), while the absolute agreement and consistency for SB, LPA, and MVPA estimates was lower (ICC ranging from 0.22-0.47). It should be noted that this study acknowledges the limitation of not treating the data as compositional data. Compositional data analysis accounts for the relative distribution of different activities and avoids the assumption of independence between behaviors. Additionally, the activPAL4 accelerometer used as the reference method in the study had its own strengths and weaknesses when compared to other objective measures, such as the Actigraph. Where ActivPAL4 is more used to differentiate between sitting and standing, Actigraph is able to better classify activity intensities. Moreover, as recommended in different research, I use the Actigraph in my PhD to objectively asses 24-hour movement behaviors. Given these considerations, the aim of this study is to validate the DABQ against the Actigraph as the reference method. Furthermore, this study aims to analyze the data as compositional data, which would provide a more comprehensive understanding of the interrelatedness of behaviors. The hypothesis is that there will be moderate convergent validity between the DABQ and Actigraph, allowing for accurate assessment of sleep duration, SB, LPA, and MVPA. By establishing the validity of the DABQ and considering the data as compositional, researchers can utilize this questionnaire in time-use epidemiology studies, which could be seen as an easy to use and cost-effective measurement method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

February 26, 2024

Last Update Submit

August 7, 2024

Conditions

Keywords

convergent validityActigraphDaily activity behavior questionnaire24-hour movement behaviors

Outcome Measures

Primary Outcomes (3)

  • Total 24-hour movement behaviors collected by the Actigraph GT3X+BT

    The Actigraph GT3X+BT will objectively collect time spent in sleep, sedentary behavior and physical activity. This device will be worn be the participants during 7 consecutive days (at night at their non-dominant wrist and during the day at their right hip).

    Through study completion, an average of 2 weeks

  • Total 24-hour movement behaviors collected by the Daily Activity Behavior Questionnaire (DABQ)

    This questionnaire will subjectively collect time spent in sleep, sedentary behavior and physical activity. This questionnaire will be filled in at the end of the 7 days wearing the Actigraph mentioned in outcome 1.

    Through study completion, an average of 2 weeks

  • Convergent validity between time spent in 24-hour movement behaviors collected by the Actigraph GT3X+BT and DABQ

    Intraclass correlation coefficient (95% confidence intervals) and pearson/spearman correlation will be used to measure the convergent validity and intermeasurement reliability. This method allows the comparison between self-reported use of time and the device measured use of time for each behavior separately.

    Through study completion, an average of 2 weeks

Secondary Outcomes (12)

  • Participant characteristics "sex" potentially explaining biases in reporting 24-hour movement behaviors.

    Through study completion, an average of 2 weeks

  • Participant characteristics "age" potentially explaining biases in reporting 24-hour movement behaviors.

    Through study completion, an average of 2 weeks

  • Participant characteristics "body mass index" potentially explaining biases in reporting 24-hour movement behaviors.

    Through study completion, an average of 2 weeks

  • Participant characteristics "family situation" potentially explaining biases in reporting 24-hour movement behaviors.

    Through study completion, an average of 2 weeks

  • Participant characteristics "children" potentially explaining biases in reporting 24-hour movement behaviors.

    Through study completion, an average of 2 weeks

  • +7 more secondary outcomes

Study Arms (1)

Adults

OTHER

In this study, participants will have one contact session with the researcher, which will be held either at Ghent University Hospital or at the participants' home. During this session, participants will be provided with an accelerometer device and two questionnaires (to be filled in after wearing the Actigraph), namely the Daily Activity Behavior Questionnaire (DABQ) and general information questionnaire. The participants will receive an Actigraph wGT3X+BT accelerometer which will be worn for seven consecutive days. Instructions will be given on how to wear the accelerometer (e.g. during the day at the hip and during the night at the wrist). At the end of this week, the participants will fill in both questionnaires. After wearing the accelerometer for seven consecutive days and filling in both questionnaires, the researcher will visit the participants to collect the devices, or the participants will send them back by postal package.

Device: DABQ questionnaire versus Actigraph as reference method

Interventions

In this study, participants will have one contact session with the researcher, which will be held either at Ghent University Hospital or at the participants' home. During this session, participants will be provided with an accelerometer device and two questionnaires (to be filled in after wearing the Actigraph), namely the Daily Activity Behavior Questionnaire (DABQ) and general information questionnaire. The participants will receive an Actigraph wGT3X+BT accelerometer which will be worn for seven consecutive days. Instructions will be given on how to wear the accelerometer (e.g. during the day at the hip and during the night at the wrist). At the end of this week, the participants will fill in both questionnaires. After wearing the accelerometer for seven consecutive days and filling in both questionnaires, the researcher will visit the participants to collect the devices, or the participants will send them back by postal package.

Adults

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adults between 18 and 65 years old

You may not qualify if:

  • Physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis conditions that obstruct daily functioning
  • Cognitive (e.g. dementia, psychological disorders) conditions that obstruct daily functioning
  • Major medical (e.g. Chronic respiratory diseases, heart failure, cardiovascular diseases) conditions that obstruct daily functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent university Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marieke De Craemer

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: convergent validity of a daily activity behavior questionnaire with the actigraph as reference among healthy adults
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

June 20, 2024

Study Start

September 30, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations