Clinical trial NCT05367570: 24-hour Movement Behaviors Among Normal Weight, Overweight and Obese Adults
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Keywords: physical activity
sedentary behavior
sleep
24-hour movement behaviors
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2022-05-10
Enrollment: 250
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 24-hour movement behaviors
timeFrame: Through study completion, an average of 6 months to 1 year
Secondary outcomes:
measure: Demographics
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Dietary factors
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Quality of Life (QoL)
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Depression
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Behavioral factors
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Environmental factor
timeFrame: Through study completion, an average of 6 months to 1 year
measure: HbA1c
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Glucose
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Triglycerides
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Cholesterol (total, HDL, LDL)
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Body mass index
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Waist circumference
timeFrame: Through study completion, an average of 6 months to 1 year
measure: waist to hip ratio (WHR)
timeFrame: Through study completion, an average of 6 months to 1 year
measure: body fat percentage
timeFrame: Through study completion, an average of 6 months to 1 year
measure: blood pressure
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Advanced Glycation Endproducts (AGE's)
timeFrame: Through study completion, an average of 6 months to 1 year
measure: Obstructive sleep apnea (OSA's) risk
timeFrame: Through study completion, an average of 6 months to 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital, Dept. of Endocrinoly
state: East-Flanders
Study officials:
affiliation: Ghent University Hospital - endocrinologist
name: Bruno Lapauw, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Marieke De Craemer, Professor
role: PRINCIPAL_INVESTIGATOR
References: