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

Overweight and Obesity Clinical Trial

— OwOb_24hmb  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367570
• Other study ID #: ONZ-2022-0013
• Status: Completed
• Start date: April 18, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 31, 2023
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Cross-sectional observational study
The first work package of this project is an explanatory cross-sectional study with no intervention.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital, Dept. of Endocrinoly	Ghent	East-Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year
Secondary	Waist circumference	The waist circumference will be measured with a measuring tape (Seca 201).	Through study completion, an average of 6 months to 1 year
Secondary	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)	Through study completion, an average of 6 months to 1 year
Secondary	body fat percentage	The body fat percentage will measured by 'Tanita SC-240MA'	Through study completion, an average of 6 months to 1 year
Secondary	blood pressure	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
Secondary	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	Through study completion, an average of 6 months to 1 year
Secondary	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.	Through study completion, an average of 6 months to 1 year