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Completed

NCT Number: NCT05367570

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

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.

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Key information

Age range

25 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital, Dept. of Endocrinoly

Ghent, East-Flanders, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cross-sectional observational study

Behavioral

The first work package of this project is an explanatory cross-sectional study with no intervention.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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)

  14. 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'

  15. 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

  16. 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

  17. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Acronym: OwOb_24hmb

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 10, 2022
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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