- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05367570
24-hour Movement Behaviors Among Normal Weight, Overweight and Obese Adults (OwOb_24hmb)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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East-Flanders
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Ghent, East-Flanders, Belgium, 9000
- Ghent University Hospital, Dept. of Endocrinoly
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
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The first work package of this project is an explanatory cross-sectional study with no intervention.
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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.
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The first work package of this project is an explanatory cross-sectional study with no intervention.
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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
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Through study completion, an average of 6 months to 1 year
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Dietary factors
Time Frame: Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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Quality of Life (QoL)
Time Frame: Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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Environmental factor
Time Frame: Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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Triglycerides
Time Frame: Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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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
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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.
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Through study completion, an average of 6 months to 1 year
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Waist circumference
Time Frame: Through study completion, an average of 6 months to 1 year
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The waist circumference will be measured with a measuring tape (Seca 201).
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Through study completion, an average of 6 months to 1 year
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waist to hip ratio (WHR)
Time Frame: Through study completion, an average of 6 months to 1 year
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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)
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Through study completion, an average of 6 months to 1 year
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body fat percentage
Time Frame: Through study completion, an average of 6 months to 1 year
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The body fat percentage will measured by 'Tanita SC-240MA'
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Through study completion, an average of 6 months to 1 year
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blood pressure
Time Frame: Through study completion, an average of 6 months to 1 year
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Blood pressure will be measured twice (interval of one minute) with an automatic OMRON M6 Comfort device after 10 minutes of rest
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Through study completion, an average of 6 months to 1 year
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Advanced Glycation Endproducts (AGE's)
Time Frame: Through study completion, an average of 6 months to 1 year
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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
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Through study completion, an average of 6 months to 1 year
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Obstructive sleep apnea (OSA's) risk
Time Frame: Through study completion, an average of 6 months to 1 year
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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.
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Through study completion, an average of 6 months to 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruno Lapauw, Professor, Ghent University Hospital - endocrinologist
- Principal Investigator: Marieke De Craemer, Professor, University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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