NCT05367570

Brief Summary

The prevalence of adults with overweight (50%) and obesity (15%) reached high number in Belgium. Important lifestyle behaviors, i.e. sleep, sedentary time (SB), and physical activity (PA) subdivided into light physical activity (LPA) and moderate to vigorous physical activity (MVPA), have shown an impact on overweight and obesity characteristics (e.g. adiposity). However, these behaviors have often been investigated separately. Therefore, a recent shift in research emphasizes the importance of considering these behaviors as part of a 24-hour day. Since these adults can benefit from an optimal 24-hour composition as part of a healthy lifestyle, it may be interesting to investigate the 24-hour movement composition among these adults. In addition, exploring different personal determinants, environmental determinants, and cardiometabolic markers will provide meaningful insights in developing an intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

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

April 18, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 27, 2022

Last Update Submit

April 11, 2024

Conditions

Keywords

physical activitysedentary behaviorsleep24-hour movement behaviors

Outcome Measures

Primary Outcomes (1)

  • 24-hour movement behaviors

    During their visit to Ghent University hospital, participants will receive a 'wGT3X-BT' 'ActiGraph accelerometer that will objectively measure their 24-hour movement behaviors (PA, SB, and sleep). The participants will wear the accelerometer for seven consecutive days. Additionally, this accelerometer data will be supplemented with a diary to validate sleep time and (non)wear time.

    Through study completion, an average of 6 months to 1 year

Secondary Outcomes (17)

  • Demographics

    Through study completion, an average of 6 months to 1 year

  • Dietary factors

    Through study completion, an average of 6 months to 1 year

  • Quality of Life (QoL)

    Through study completion, an average of 6 months to 1 year

  • Depression

    Through study completion, an average of 6 months to 1 year

  • Behavioral factors

    Through study completion, an average of 6 months to 1 year

  • +12 more secondary outcomes

Study Arms (2)

Normal weight group

The first work package of this study is cross-sectional. The investigators will investigate the 24-hour movement behaviors, cardiometabolic parameters and some personal and environmental correlates.

Behavioral: Cross-sectional observational study

Overweight/obesity group

The first work package of this study is cross-sectional The investigators will investigate the 24-hour movement behaviors, cardiometabolic parameters and some personal and environmental correlates.

Behavioral: Cross-sectional observational study

Interventions

The first work package of this project is an explanatory cross-sectional study with no intervention.

Normal weight groupOverweight/obesity group

Eligibility Criteria

Age25 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

One hundred seventy-two adults will be distributed into a Nw group and an OwOb group. Based on the Health Survey (2018), the general Belgian population has a prevalence of 50 percent OwOb adults. Therefore the distribution in this cross-sectional study will follow these percentages: 50 percent Nw adults (n=86) and 50 percent OwOb adults (n=86). Based on the Health Survey (2018), the group of OwOb adults can be divided into 35 percent Ow adults and 15 percent Ob adults. This represents itself in the inclusion of 60 adults (35%) with overweight and 26 adults (15%) with obesity. Adults of the Nw group will be matched with the OwOb group based on sex and age.

You may qualify if:

  • Adults aged 25-64 years
  • Active on the job market for at least 50 percent
  • BMI ≥25kg/m² and Waist Circumference C ≥94cm for men and ≥80 cm for women
  • Adults aged 25-64 years
  • Active on the job market for at least 50 percent
  • BMI \<25kg/m² and Waist Circumference \<94cm for men and \<80 cm for women

You may not qualify if:

  • Retirement and early retirement
  • Unemployment
  • Working for less than 50 percent
  • Working in night shifts
  • Physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis), cognitive (e.g. dementia, psychological disorders) and major medical (e.g. Chronic respiratory diseases, heart failure, cardiovascular diseases) conditions that obstruct daily functioning
  • Taking diabetes related medication
  • Active treatment for cancer
  • Pregnancy
  • Breastfeeding
  • Pregnancy \<1 year ago
  • Currently involved in study specific weight loss interventions
  • Waitlist for weight loss surgery
  • Weight loss surgery \<1 year ago
  • Taking medication which affects your body weight (e.g. thyroid medication, psychotropic medication)
  • Thyroid problems which affects your body weight
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital, Dept. of Endocrinoly

Ghent, East-Flanders, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood sample will be collected in order to analyze HbA1c, Cholesterol, glucose, triglycerides

MeSH Terms

Conditions

OverweightObesityMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Bruno Lapauw, Professor

    Ghent University Hospital - endocrinologist

    PRINCIPAL INVESTIGATOR
  • Marieke De Craemer, Professor

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 10, 2022

Study Start

April 18, 2022

Primary Completion

December 16, 2022

Study Completion

October 31, 2023

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations