24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients

December 7, 2023 updated by: University Hospital, Ghent

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The present study aims (1) to conduct a longitudinal observational study over two years to explore 24-hour movement behavior composition patterns among T2DM patients in comparison with a healthy control group and (2) to examine associations between these movement behaviors and personal and environmental determinants, and cardiometabolic markers. This study's primary endpoint is to develop insights into the 24-hour movement composition combined with T2DM patients' characteristics, determinants, and health profile to set the groundwork with the aim to develop, implement and evaluate an intervention in a future randomized controlled trial

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Ghent University Hospital, Dept. of Endocrinology
        • Contact:
          • Bruno Lapauw, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The main focus of this project is to explore 24-hour movement behavior among type 2 diabetes mellitus patients. However, the control group will be included because of lacking evidence on the 24-hour movement pattern in the general Belgian 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
type 2 diabetes mellitus group
124 adults with type 2 diabetes mellitus will be included
Other: No intervention
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
Other: No intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruno Lapauw, Professor, Ghent University Hospital - endocrinologist
  • Principal Investigator: Marieke De Craemer, Professor, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC-10189

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings