24-hour Movement Behaviors Among Normal Weight, Overweight and Obese Adults (OwOb_24hmb)

April 11, 2024 updated by: University Hospital, Ghent

Move, Sit, Sleep, Repeat: Exploring 24-hour Movement Behaviors Among Normal Weight, Overweight and Obese Adults and the Power of Co-created Interventions

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • East-Flanders
      • Ghent, East-Flanders, Belgium, 9000
        • Ghent University Hospital, Dept. of Endocrinoly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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.

Description

Inclusion criteria OwOb group

  • 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

Inclusion criteria Nw participants

  • 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

Exclusion criteria Nw, Ow, Ob patients

  • 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
  • Hospitalized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
The first work package of this project is an explanatory cross-sectional study with no intervention.
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.
The first work package of this project is an explanatory cross-sectional study with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour movement behaviors
Time Frame: Through study completion, an average of 6 months to 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Through study completion, an average of 6 months to 1 year
The following demographics will be questioned: age, sex, marital status, family situation, living environment, ethnicity, smoking, educational level, profession, net family income, and medication intake, PA participation, dietary interventions
Through study completion, an average of 6 months to 1 year
Dietary factors
Time Frame: Through study completion, an average of 6 months to 1 year
A Food Frequency Questionnaire will collect dietary information. This questionnaire is based on the Flemish food-based dietary guidelines for adults. This questionnaire can make a distinction between following a healthy plant based diet and unhealthy plant based diet.
Through study completion, an average of 6 months to 1 year
Quality of Life (QoL)
Time Frame: Through study completion, an average of 6 months to 1 year
The Health related quality of life scale 'Short Form Health Survey' (SF-12) is classified into 8domains: physical functioning, role-physical, bodily pail, general health, energy/fatigue, social functioning, role-emotional, mental health. Scale is between 0 and 100 where a higher score reflects a better QoL.
Through study completion, an average of 6 months to 1 year
Depression
Time Frame: Through study completion, an average of 6 months to 1 year
The Beck Depression Inventory will be used to screen for depression among this target group. It is one of the most widely used depression instruments. It measures both the intensity of depression as well as a screening for depression in Nw and OwOb adults. The Scale is between 0 an 63 where a higher score reflects a higher susceptibility of depression.
Through study completion, an average of 6 months to 1 year
Behavioral factors
Time Frame: Through study completion, an average of 6 months to 1 year
The following behaviors will be questioned: autonomous motivation, attitude, self-efficacy, subjective norm, internal control (i.e. habits, routines, skills), and external control (i.e. perceived barriers, real barriers). These questions are part a self-developped questionnaire which is currently tested for reliability. The scores will be calculated based on the cumulative percentage of the group. A higher score reflects a higher score on the specific behavioral construct.
Through study completion, an average of 6 months to 1 year
Environmental factor
Time Frame: Through study completion, an average of 6 months to 1 year
The environmental factors are divided into socio-environmental factors and physical environmental factors. Socio-environmental factors are social support and modeling. Physical environmental factors are walkability, neighborhood, work environment, sleep environment, and electronic devices at home. These questions are part a self-developped questionnaire which is currently tested for reliability. The scores will be calculated based on the cumulative percentage of the group. A higher score reflects a higher score on the specific environmental construct.
Through study completion, an average of 6 months to 1 year
HbA1c
Time Frame: Through study completion, an average of 6 months to 1 year
Blood parameters will be collected by a study nurse. This blood sample will be collected in a EDTA tube and will be analyzed by the clinical lab of Ghent university Hospital.
Through study completion, an average of 6 months to 1 year
Glucose
Time Frame: Through study completion, an average of 6 months to 1 year
Blood parameters will be collected by a study nurse. This blood sample will be collected in a Serum tube and will be analyzed by the clinical lab of Ghent university Hospital.
Through study completion, an average of 6 months to 1 year
Triglycerides
Time Frame: Through study completion, an average of 6 months to 1 year
Blood parameters will be collected by a study nurse. This blood sample will be collected in a Serum tube and will be analyzed by the clinical lab of Ghent university Hospital.
Through study completion, an average of 6 months to 1 year
Cholesterol (total, HDL, LDL)
Time Frame: Through study completion, an average of 6 months to 1 year
Blood parameters will be collected by a study nurse. This blood sample will be collected in a Serum tube and will be analyzed by the clinical lab of Ghent university Hospital.
Through study completion, an average of 6 months to 1 year
Body mass index
Time Frame: Through study completion, an average of 6 months to 1 year
BMI will be calculated by measuring weight (Seca 861) and height (Seca 213). The weight and height will be used in this formula: BMI (kg/m²)= (weight in kg)/(height in m)².
Through study completion, an average of 6 months to 1 year
Waist circumference
Time Frame: Through study completion, an average of 6 months to 1 year
The waist circumference will be measured with a measuring tape (Seca 201).
Through study completion, an average of 6 months to 1 year
waist to hip ratio (WHR)
Time Frame: Through study completion, an average of 6 months to 1 year
The hip circumference will be measured with a measuring tape (Seca 201).Both waist and hip circumferences will be used to calculate WHR= (waist circumference in cm)/ (hip circumference in cm)
Through study completion, an average of 6 months to 1 year
body fat percentage
Time Frame: Through study completion, an average of 6 months to 1 year
The body fat percentage will measured by 'Tanita SC-240MA'
Through study completion, an average of 6 months to 1 year
blood pressure
Time Frame: Through study completion, an average of 6 months to 1 year
Blood pressure will be measured twice (interval of one minute) with an automatic OMRON M6 Comfort device after 10 minutes of rest
Through study completion, an average of 6 months to 1 year
Advanced Glycation Endproducts (AGE's)
Time Frame: Through study completion, an average of 6 months to 1 year
AGE's are interesting to explore as predictors in developing several comorbidities (e.g. cardiovascular diseases, microvascular complications). They will be measured with an AGE-reader, which is a quick and non-invasive device
Through study completion, an average of 6 months to 1 year
Obstructive sleep apnea (OSA's) risk
Time Frame: Through study completion, an average of 6 months to 1 year
To measure OSA's risk, I will measure the participants' neck circumference by a measuring tape (Seca 201) and ask questions based on the STOP-BANG questionnaire. Scale ranges between 0 and 8. A higher score reflects a higher risk for OSA.
Through study completion, an average of 6 months to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Bruno Lapauw, Professor, Ghent University Hospital - endocrinologist
  • Principal Investigator: Marieke De Craemer, Professor, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2022

Primary Completion (Actual)

December 16, 2022

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2022-0013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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