Overweight and ObesityOwOb_24hmbNCT05367570
24-hour Movement Behaviors Among Normal Weight, Overweight and Obese Adults
An observational study of Overweight and Obesity, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Cross-sectional observational study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Apr 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University Hospital, Dept. of Endocrinoly
Ghent, East-Flanders, 9000
About this study
Official title: 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.
- Conditions
- Overweight and Obesity
- Being tested
- Cross-sectional observational study
- Keywords
- physical activity, sedentary behavior, sleep, 24-hour movement behaviors
- Medical subject headings
- Overweight, Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional observational studyBehavioural
The first work package of this project is an explanatory cross-sectional study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cross-sectional observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months to 1 year
Secondary outcomes (17)
Demographics
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
Measured: Through study completion, an average of 6 months to 1 year
Dietary factors
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.
Measured: Through study completion, an average of 6 months to 1 year
Quality of Life (QoL)
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.
Measured: Through study completion, an average of 6 months to 1 year
Depression
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.
Measured: Through study completion, an average of 6 months to 1 year
Behavioral factors
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.
Measured: Through study completion, an average of 6 months to 1 year
Environmental factor
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.
Measured: Through study completion, an average of 6 months to 1 year
HbA1c
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.
Measured: Through study completion, an average of 6 months to 1 year
Glucose
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.
Measured: Through study completion, an average of 6 months to 1 year
Triglycerides
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.
Measured: Through study completion, an average of 6 months to 1 year
Cholesterol (total, HDL, LDL)
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.
Measured: Through study completion, an average of 6 months to 1 year
Body mass index
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.
Measured: Through study completion, an average of 6 months to 1 year
Waist circumference
The waist circumference will be measured with a measuring tape (Seca 201).
Measured: Through study completion, an average of 6 months to 1 year
waist to hip ratio (WHR)
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)
Measured: Through study completion, an average of 6 months to 1 year
body fat percentage
The body fat percentage will measured by 'Tanita SC-240MA'
Measured: Through study completion, an average of 6 months to 1 year
blood pressure
Blood pressure will be measured twice (interval of one minute) with an automatic OMRON M6 Comfort device after 10 minutes of rest
Measured: Through study completion, an average of 6 months to 1 year
Advanced Glycation Endproducts (AGE's)
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
Measured: Through study completion, an average of 6 months to 1 year
Obstructive sleep apnea (OSA's) risk
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.
Measured: Through study completion, an average of 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start18 Apr 2022
- Primary completion16 Dec 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Bruno Lapauw, Professor, Principal investigator, Ghent University Hospital - endocrinologistMarieke De Craemer, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367570
- Sponsor's protocol ID
- ONZ-2022-0013
- Acronym
- OwOb_24hmb
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move, Sit, Sleep, Repeat: Exploring 24-hour Movement Behaviors Among Normal Weight, Overweight and Obese Adults and the Power of Co-created Interventions
- ClinicalTrials.gov ID
- NCT05367570
- Acronym / sponsor ID
- OwOb_24hmb / ONZ-2022-0013
- Conditions
- Overweight and Obesity
- Keywords
- physical activity, sedentary behavior, sleep, 24-hour movement behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight group | – | Behavioral: Cross-sectional observational studyThe 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. |
| Overweight/obesity group | – | Behavioral: Cross-sectional observational studyThe 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. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-sectional observational studyThe first work package of this project is an explanatory cross-sectional study with no intervention. | Behavioural | Normal weight group, Overweight/obesity group |
Primary outcome
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.
17 secondary outcomes
Demographics
Time frame: 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
Quality of Life (QoL)
Time frame: 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
Behavioral factors
Time frame: 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
HbA1c
Time frame: 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
Triglycerides
Time frame: 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
Body mass index
Time frame: 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
waist to hip ratio (WHR)
Time frame: 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
blood pressure
Time frame: 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
Obstructive sleep apnea (OSA's) risk
Time frame: Through study completion, an average of 6 months to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Lapauw, Professor principal investigator
Ghent University Hospital - endocrinologist
Marieke De Craemer, Professor principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour movement behaviors (time frame: Through study completion, an average of 6 months to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.