- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04993482
24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
A healthy lifestyle has proved beneficial health effects in managing type 2 diabetes mellitus (T2DM). 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 T2DM disease-specific characteristics (e.g. glycemic control). 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 T2DM patients 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 T2DM patients over time. Moreover, exploring associations with different personal determinants, environmental determinants, and cardiometabolic markers will provide meaningful insights in developing recommendations and creating an intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Iris Willems, PhD student
- Phone Number: 093323638
- Email: willems.iris@ugent.be
Study Contact Backup
- Name: Marieke De Craemer, Professor
- Phone Number: 09 332 52 08
- Email: Marieke.Decraemer@ugent.be
Study Locations
-
-
-
Ghent, Belgium, 9000
- Recruiting
- Ghent University Hospital, Dept. of Endocrinology
-
Contact:
- Bruno Lapauw, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria T2DM patients
- Adults aged >18 years old
- Diagnosed with T2DM by a physician or an HbA1C above 6.5%
Exclusion criteria T2DM patients
- Diagnosed with type 1 diabetes mellitus (T1DM)
- Diagnosed with pregnancy diabetes
- Diagnosed with latent autoimmune diabetes in adults (LADA)
- Physical disabilities that obstruct the normal PA pattern (e.g. amputations, paralysis)
- Cognitive disabilities that obstruct daily functioning (e.g. dementia, psychological disorders)
- Other conditions affecting the normal PA pattern (e.g. heart failure NYHA class 3 and 4, chronic respiratory diseases (COPD stage 4), end stage nonalcoholic fatty liver disease, end stage renal failure, cancer, hospitalized)
- Pregnancy or pregnancy <1 year ago
- Participating in a physical activity intervention
Inclusion criteria control participants
- Adults aged > 18 years old
Exclusion criteria control participants
- Diagnosed with T2DM
- Diagnosed with T1DM
- Diagnosed with pregnancy diabetes
- Diagnosed with LADA
- Physical disabilities that obstruct the normal PA pattern (e.g. amputations, paralysis)
- Cognitive disabilities that obstruct daily functioning (e.g. dementia, psychological disorders)
- Other conditions affecting the normal PA pattern (e.g. heart failure NYHA class 3 and 4, chronic respiratory diseases (COPD stage 4), end stage nonalcoholic fatty liver disease, end stage renal failure, cancer, hospitalized)
- Pregnancy or pregnancy <1 year ago
- Participating in a physical activity intervention
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
type 2 diabetes mellitus group
124 adults with type 2 diabetes mellitus will be included
|
This project contains a longitudinal observational study design.
The investigator will collect data out of a group with type 2 diabetes mellitus patients and out of group with control adults on three time points (baseline, follow-up after one year, and follow-up after two years).
Therefore, the investigator will only collect observational data and the participants will not be exposed to a certain intervention.
|
|
control group
124 control adults will be included
|
This project contains a longitudinal observational study design.
The investigator will collect data out of a group with type 2 diabetes mellitus patients and out of group with control adults on three time points (baseline, follow-up after one year, and follow-up after two years).
Therefore, the investigator will only collect observational data and the participants will not be exposed to a certain intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 24-hour movement composition from baseline over one year and two-year follow-up
Time Frame: Baseline
|
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.
Furthermore, the individuals will subjectively report on their PA, SB, and sleep (duration and quality) through an online questionnaire based on international standardized PA (IPAQ), SB (SIT-Q-7d), and sleep questionnaires (Munich Chronotype questionnaire, Pittsburg sleep quality index, and Sleep Hygiene Index) (IPAQ, Sit-7Q, Munich Chronotype questionnaire, and Pittsburg sleep quality index, Sleep Hygiene Index).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
Baseline
|
|
Change in 24-hour movement composition from baseline over one year and two-year follow-up
Time Frame: The same primary outcome will be collected after one 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.
Furthermore, the individuals will subjectively report on their PA, SB, and sleep (duration and quality) through an online questionnaire based on international standardized PA (IPAQ), SB (SIT-Q-7d), and sleep questionnaires (Munich Chronotype questionnaire, Pittsburg sleep quality index, and Sleep Hygiene Index) (IPAQ, Sit-7Q, Munich Chronotype questionnaire, and Pittsburg sleep quality index, Sleep Hygiene Index).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same primary outcome will be collected after one year
|
|
Change in 24-hour movement composition from baseline over one year and two-year follow-up
Time Frame: The same primary outcome will be collected after two years
|
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.
Furthermore, the individuals will subjectively report on their PA, SB, and sleep (duration and quality) through an online questionnaire based on international standardized PA (IPAQ), SB (SIT-Q-7d), and sleep questionnaires (Munich Chronotype questionnaire, Pittsburg sleep quality index, and Sleep Hygiene Index) (IPAQ, Sit-7Q, Munich Chronotype questionnaire, and Pittsburg sleep quality index, Sleep Hygiene Index).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same primary outcome will be collected after two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HbA1c from baseline to two-year follow-up
Time Frame: baseline
|
HbA1C will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Change in HbA1c from baseline to two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
HbA1C will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up
Time Frame: baseline
|
Cholesterol (total, HDL, LDL) will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
Cholesterol (total, HDL, LDL) will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in triglycerides from baseline to two-year follow-up
Time Frame: Baseline
|
Triglycerides will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
Baseline
|
|
Change in triglycerides from baseline to two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
Triglycerides will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in insulin from baseline to two-year follow-up
Time Frame: Baseline
|
Insulin will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
Baseline
|
|
Change in insulin from baseline to two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
Insulin will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in glucose from baseline to two-year follow-up
Time Frame: Baseline
|
Glucose will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
Baseline
|
|
Change in glucose from baseline to two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
Glucose will only be collected within the type 2 diabetes group.
This will be collected by an analysis of a fasting blood sample.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up
Time Frame: Baseline
|
The HOMA Is a method to quantify insulin resistance and beta-cell function.
HOMA-IR and HOMA-B will only be collected within the type 2 diabetes group.
The HOMA-IR and HOMA-B will be calculated based on the collected insulin and glucose level by the HOMA2 calculator.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
Baseline
|
|
Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
The HOMA Is a method to quantify insulin resistance and beta-cell function.
HOMA-IR and HOMA-B will only be collected within the type 2 diabetes group.
The HOMA-IR and HOMA-B will be calculated based on the collected insulin and glucose level by the HOMA2 calculator.
By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
Time Frame: baseline
|
BMI will be calculated by measuring weight (in kilograms) (Seca 861) and height (in meters) (Seca 213).
The weight and height will be used in this formula: BMI (kg/m²)= (weight in kg)/(height in m)².
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
Time Frame: The same secondary outcome will be collected after one year
|
BMI will be calculated by measuring weight (in kilograms) (Seca 861) and height (in meters) (Seca 213).
The weight and height will be used in this formula: BMI (kg/m²)= (weight in kg)/(height in m)².
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after one year
|
|
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
BMI will be calculated by measuring weight (in kilograms) (Seca 861) and height (in meters) (Seca 213).
The weight and height will be used in this formula: BMI (kg/m²)= (weight in kg)/(height in m)².
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in waist circumference from baseline to one and two-year follow-up
Time Frame: Baseline
|
The waist circumference and hip circumference will be measured with a measuring tape (Seca 201).
Both measurements will be used to calculate the waist-to-hip ratio, i.e.
WHR= (waist circumference in cm)/ (hip circumference in cm).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
Baseline
|
|
Change in waist circumference from baseline to one and two-year follow-up
Time Frame: The same secondary outcome will be collected after one year
|
The waist circumference and hip circumference will be measured with a measuring tape (Seca 201).
Both measurements will be used to calculate the waist-to-hip ratio, i.e.
WHR= (waist circumference in cm)/ (hip circumference in cm).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after one year
|
|
Change in waist circumference from baseline to one and two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
The waist circumference and hip circumference will be measured with a measuring tape (Seca 201).
Both measurements will be used to calculate the waist-to-hip ratio, i.e.
WHR= (waist circumference in cm)/ (hip circumference in cm).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
Time Frame: baseline
|
Diastolic and systolic (mm Hg) blood pressure will be measured twice (interval of one minute) with an automatic OMRON M6 Comfort device after 10 minutes of rest.
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
Time Frame: The same secondary outcome will be collected after one year
|
Diastolic and systolic (mm Hg) blood pressure will be measured twice (interval of one minute) with an automatic OMRON M6 Comfort device after 10 minutes of rest.
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after one year
|
|
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
Diastolic and systolic (mm Hg) blood pressure will be measured twice (interval of one minute) with an automatic OMRON M6 Comfort device after 10 minutes of rest.
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
|
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
Time Frame: baseline
|
AGE's are interesting to explore as predictors in developing several comorbidities (e.g.
cardiovascular diseases, microvascular complications).
Predictors will be measured with an AGE-reader, which is a quick and non-invasive device.
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
Time Frame: The same secondary outcome will be collected after one year
|
AGE's are interesting to explore as predictors in developing several comorbidities (e.g.
cardiovascular diseases, microvascular complications).
Predictors will be measured with an AGE-reader, which is a quick and non-invasive device.
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after one year
|
|
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
Time Frame: The same secondary outcome will be collected after two years
|
AGE's are interesting to explore as predictors in developing several comorbidities (e.g.
cardiovascular diseases, microvascular complications).
Predictors will be measured with an AGE-reader, which is a quick and non-invasive device.
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same secondary outcome will be collected after two years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explanatory variables: change in demographics from baseline to one and two-year follow-up
Time Frame: baseline
|
The following demographics will be questioned: age, sex, ethnicity, smoking, educational level, profession, family situation, medication intake, and timing of T2DM diagnosis (only for the T2DM patient group).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Explanatory variables: change in demographics from baseline to one and two-year follow-up
Time Frame: The same explanatory outcome will be collected after one year
|
The following demographics will be questioned: age, sex, ethnicity, smoking, educational level, profession, family situation, medication intake, and timing of T2DM diagnosis (only for the T2DM patient group).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after one year
|
|
Explanatory variables: change in demographics from baseline to one and two-year follow-up
Time Frame: The same explanatory outcome will be collected after two years
|
The following demographics will be questioned: age, sex, ethnicity, smoking, educational level, profession, family situation, medication intake, and timing of T2DM diagnosis (only for the T2DM patient group).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after two years
|
|
Explanatory variables: change in dietary factors from baseline to one and two-year follow-up
Time Frame: baseline
|
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 an intake of a healthy plant based diet or unhealthy plant based diet.
A higher score means a more healthy plant based diet (min.
16 and max 80).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Explanatory variables: change in dietary factors from baseline to one and two-year follow-up
Time Frame: The same explanatory outcome will be collected after one 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 an intake of a healthy plant based diet or unhealthy plant based diet.
A higher score means a more healthy plant based diet (min.
16 and max.
80).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after one year
|
|
Explanatory variables: change in dietary factors from baseline to one and two-year follow-up
Time Frame: The same explanatory outcome will be collected after two years
|
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 an intake of a healthy plant based diet or unhealthy plant based diet.
A higher score means a more healthy plant based diet (min.
16 and max.
80).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after two years
|
|
Explanatory variables: change in quality of Life (QoL) from baseline to one and two-year follow-up
Time Frame: baseline
|
The WHOQoL-BREF quality of life scale is classified into four domains: Physical health, psychological well-being, social relationships, and environmental health.
A better score means a better QoL (min.
0 and max.
100).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Explanatory variables: change in quality of Life (QoL) from baseline to one and two-year follow-up
Time Frame: The same explanatory outcome will be collected after one year
|
The WHOQoL-BREF quality of life scale is classified into four domains: Physical health, psychological well-being, social relationships, and environmental health.
A better score means a better QoL (min.
0 and max.
100).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after one year
|
|
Explanatory variables: change in quality of Life (QoL) from baseline to one and two-year follow-up
Time Frame: The same explanatory outcome will be collected after two years
|
The WHOQoL-BREF quality of life scale is classified into four domains: Physical health, psychological well-being, social relationships, and environmental health.
A better score means a better QoL (min.
0 and max.
100).
By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after two years
|
|
Explanatory variables: Behavioral factors
Time Frame: baseline
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
This questionnaire questions the behavioral factors included within the integrated behavior change model i.e. autonomous motivation, attitude, self-efficacy, subjective norm, internal control and external control.
A higher score means a behavior factor that positively relates to the health behavior.
Furthermore, the cut-off point for the behavioral factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Explanatory variables: Behavioral factors
Time Frame: The same explanatory outcome will be collected after one year
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
This questionnaire questions the behavioral factors included within the integrated behavior change model i.e. autonomous motivation, attitude, self-efficacy, subjective norm, internal control and external control.
A higher score means a behavior factor that positively relates to the health behavior.
Furthermore, the cut-off point for the behavioral factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after one year
|
|
Explanatory variables: Behavioral factors
Time Frame: The same explanatory outcome will be collected after two years
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
This questionnaire questions the behavioral factors included within the integrated behavior change model i.e. autonomous motivation, attitude, self-efficacy, subjective norm, internal control and external control.
A higher score means a behavior factor that positively relates to the health behavior.
Furthermore, the cut-off point for the behavioral factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after two years
|
|
Explanatory variables: socio-environmental factors
Time Frame: baseline
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
Socio-environmental factors include questions regarding social support and modeling.
A higher score means a socio-environmental factors that positively relates to the health behavior.
Furthermore, the cut-off point for the socio-environmental factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Explanatory variables: socio-environmental factors
Time Frame: The same explanatory outcome will be collected after one year
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
Socio-environmental factors include questions regarding social support and modeling.
A higher score means a socio-environmental factors that positively relates to the health behavior.
Furthermore, the cut-off point for the socio-environmental factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after one year
|
|
Explanatory variables: socio-environmental factors
Time Frame: The same explanatory outcome will be collected after two years
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
Socio-environmental factors include questions regarding social support and modeling.
A higher score means a socio-environmental factors that positively relates to the health behavior.
Furthermore, the cut-off point for the socio-environmental factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after two years
|
|
Explanatory variables: physical environmental factors
Time Frame: baseline
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
Physical environmental factors include questions regarding walkability, neighborhood, work environment, sleep environment, and electronic devices at home.
A higher score means a physical environmental factors that positively relates to the health behavior.
Furthermore, the cut-off point for the physical environmental factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
baseline
|
|
Explanatory variables: physical environmental factors
Time Frame: The same explanatory outcome will be collected after one year
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
Physical environmental factors include questions regarding walkability, neighborhood, work environment, sleep environment, and electronic devices at home.
A higher score means a physical environmental factors that positively relates to the health behavior.
Furthermore, the cut-off point for the physical environmental factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after one year
|
|
Explanatory variables: physical environmental factors
Time Frame: The same explanatory outcome will be collected after two years
|
A new questionnaire has been developed and is currently at the final stage of testing the test-retest reliability.
Physical environmental factors include questions regarding walkability, neighborhood, work environment, sleep environment, and electronic devices at home.
A higher score means a physical environmental factors that positively relates to the health behavior.
Furthermore, the cut-off point for the physical environmental factors will be determined by the cumulative percentage.
In addition, by collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
|
The same explanatory outcome will be collected after two years
|
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 (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-10189
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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ENBIOSIS BIOTECHNOLOGIESAydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi Demirsoy... and other collaboratorsRecruitingType 2 Diabetes | Diabetes Mellitus Type 2Turkey (Türkiye)
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Instituto Nacional de Ciencias Medicas y Nutricion...Active, not recruiting
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Endogenex, Inc.Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes Mellitus | Type 2 Diabetes | Type2diabetes
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Endogenex, Inc.Not yet recruitingDiabetes Mellitus, Type 2 | Diabetes | Type 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type2Diabetes
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University of SalamancaUniversity of Salamanca; Instituto Piaget; Escola Superior de Tecnologia da Saúde...Enrolling by invitationType 2 Diabetes Mellitus | Aging | Hyperglycemia Due to Type 2 Diabetes MellitusPortugal
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University of Colorado, DenverMassachusetts General Hospital; Ann & Robert H Lurie Children's Hospital of... and other collaboratorsRecruitingDiabetes Mellitus | Diabetes | Type 2 Diabetes | Diabetes Mellitus Type 2 | Diabetes Mellitus, Type I | Diabetes Mellitus Type II | Diabetes Mellitus, Insulin-Dependent | Diabetes, Autoimmune | Type 1 Diabetes (T1D) | Diabetes Type 2 on Insulin | Diabetes, Type IIUnited States
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Kaiser PermanenteThe Permanente Medical GroupEnrolling by invitationType 2 Diabetes | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes (T2D)United States
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SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
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Steno Diabetes Center CopenhagenRecruitingDiabetes | Cognitive Impairment | Type 2 Diabetes | Diabetes Mellitus Type 2 | Cognitive Decline | Type 2 Diabetes Mellitus (T2DM)Denmark
Clinical Trials on No intervention
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Hopital FochNot yet recruitingInterstitial Lung DiseaseFrance
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Wave NeuroscienceCompletedAutistic DisorderUnited States
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University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
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Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
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Huashan HospitalZhejiang Cancer Hospital; Shanghai Zhongshan Hospital; Tongji Hospital; Qilu Hospital... and other collaboratorsRecruitingHead and Neck Squamous Cell Carcinoma | Patient Derived Organoid | Drug Sensitive Test in VitroChina
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Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
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Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
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University of Dublin, Trinity CollegeCompleted
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Hôpital Necker-Enfants MaladesUnknown