Sedentary LifestyleCWATLDPNCT03853018

Effectiveness of Activity Trackers to Reduce Sedentary Behaviour in Sedentary Adults

A study testing CWAT intervention and CWAT + motivation intervention group in people with Sedentary Lifestyle, run by Hasselt University at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the effectiveness of consumer wearable activity trackers to reduce sedentary behaviour and the impact on cardiometabolic health. Read more about this study

Who is it for?: Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Sedentary Lifestyle
What is being tested?: CWAT intervention and CWAT + motivation intervention group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteBelgium
Study dates: 15 Nov 2018to 1 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Sedentary adults
40-75 years,
<7500steps/day,
sitting time of >10h/day,
BMI 23-30 kg/m2,
body fat percentage: male: 18-25%, female: 25-35%
HbA1c < 6.0%

Who cannot join

pregnancy,
regularly (>150 min per week during the last four months) engaged in moderate-to-vigorous intensity exercise,
any known contradiction for physical activity,
systolic blood pressure >160mmHg,
diastolic blood pressure >100mmHg
more than 20 alcohol consumptions per week,
plans to follow a weight reduction program with the aid of an energy restriction diet or a physical intervention program during the study period,
participants diagnosed with any known chronic disease.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Hasselt University
Diepenbeek, Limburg, 3590

Other trials in Belgium

About this study

Official title: The Effectiveness of Consumer Wearable Activity Trackers to Reduce Sedentary Behaviour and Improve Health-related Outcomes in Sedentary Adults

This study evaluates the effectiveness of consumer wearable activity trackers to reduce sedentary behaviour and the impact on cardiometabolic health.

Read the detailed description

Chronic non-communicable diseases (NCDs), including cardiovascular diseases, cancer, chronic respiratory diseases and diabetes, are an important public health concern worldwide. Physical inactivity is one of the major contributing factors which is highly correlated with the prevalence of NCDs. On the other hand, it is well known that increased physical activity has significant health benefits and is associated with the prevention and delayed onset of many NCDs. Given the important role of physical activity in the prevention and management of NCDs it is thus important to promote physical activity. Hence, to date a multitude of physical activity recommendations and many supervised training interventions and rehabilitation programs are available to encourage physical activity in the global population. Despite this, a recent report from the World Health Organization (WHO) indicates that 23% of the adult and 80% of the adolescent population remains physically inactive. Here, long-term compliance to adequate physical activity and a healthy life style appears to be one of the main barriers explaining this discrepancy. Consequently, any strategy that improves long term adherence to adequate daily physical activity and a healthy life style, especially in an NCD population, is worthwhile investigating. In this respect and following the recent use of accelerometer-based remote monitoring of physical activity in chronic disease patients, consumer wearable activity trackers may be such a strategy. So far, consumer wearable activity trackers have been investigated mainly in the sports community. Here CWATs are used for self-monitoring and providing continuous sport performance and health related information to athletes and coaches. Interestingly, the self-management, motivational and goal setting properties of these commercially available devices may also help patients with NCDs to engage in long-term physical activity under free-living conditions in a home-based setting. Despite the widespread use of these wearables their feasibility and effectiveness on physical activity (compliance) and generic health-related outcomes, including weight, body mass index (BMI), systemic blood pressure and glycemic index, especially in patients with NCDs is not fully clear.

Therefore, the aim of this study is to investigate the effectiveness of CWATs to promote physical activity levels and cardiometabolic health in sedentary adults. A better understanding to what extent CWATs can actually improve physical activity (compliance) and health outcomes is important to increase the effectiveness and quality of health care in chronic disease populations.

Conditions: Sedentary Lifestyle
Being tested: CWAT intervention, CWAT + motivation intervention group
Medical subject headings: Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CWAT interventionDevice
Participant in the intervention group will wear an activity tracker for 12 weeks.
CWAT + motivation intervention groupDevice
Participant in the intervention group will wear an activity tracker for 12 weeks and are also motivated by the researcher via a lifestyle data platform.

Study groups in NCT03853018
Study group	Role	What they receive
Control group	No intervention	The control group is instructed to continue their habitual daily physical activity patterns and sedentary behaviour
CWAT intervention group	Experimental	The CWAT group will receive the activity tracker. Subjects will receive inactivity alerts after 1 hour of inactivity to break up sitting time and avoid prolonged sitting. During the interruptions they will be asked to walk for several minutes. Receives: Device: CWAT intervention
CWAT + motivation intervention group	Experimental	Subjects randomised into the CWATLDP intervention will receive the activity tracker and will be stimulated with the aid of coaching sessions and goal setting. Receives: Device: CWAT intervention; Device: CWAT + motivation intervention group

What is being measured

The primary outcome is the main question the study is designed to answer.

Steps per day
Physical activity will be quantified using the activPAL3™ activity monitor.
Measured: Baseline
sitting time
sedentary behaviour will be quantified using the activPAL3™ activity monitor.
Measured: baseline
Steps per day
Physical activity will be quantified using the activPAL3™ activity monitor.
Measured: week 12
sitting time
sedentary behaviour will be quantified using the activPAL3™ activity monitor.
Measured: week 12

Secondary outcomes (78)

body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Measured: baseline
body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Measured: week 12
Height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Measured: baseline
Height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Measured: week 12
DEXA (Dual Energy X-Ray)
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
Measured: baseline
DEXA (Dual Energy X-Ray)
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
Measured: week 12
Concentration of glucose
Blood analysis
Measured: baseline
Concentration of glucose
Blood analysis
Measured: week 12
Concentration of Insuline
Blood analysis
Measured: baseline
Concentration of Insuline
Blood analysis
Measured: week 12
Concentration of total cholesterol
Blood analysis
Measured: baseline
total cholesterol
Blood analysis
Measured: week 12
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Blood analysis
Measured: baseline
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Blood analysis
Measured: week 12
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Measured: baseline
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Measured: week 12
Concentration of triglyceride
Blood analysis
Measured: baseline
Concentration of triglyceride
Blood analysis
Measured: week 12
Concentration of glycated haemoglobin (HbA1c)
Blood analysis
Measured: baseline
Concentration of glycated haemoglobin (HbA1c)
Blood analysis
Measured: week 12
Concentration of uric acid
Blood analysis
Measured: baseline
Concentration of uric acid
Blood analysis
Measured: week 12
Concentration of interleukin 6 (IL-6),
Blood analysis
Measured: baseline
Concentration of interleukin 6 (IL-6),
Blood analysis
Measured: week 12
Concentration of tumor necrosis factor-alpha (TNF-α),
Blood analysis
Measured: baseline
Concentration of tumor necrosis factor-alpha (TNF-α),
Blood analysis
Measured: week 12
Concentration of C-reactive protein (CRP)
Blood analysis
Measured: baseline
Concentration of C-reactive protein (CRP)
Blood analysis
Measured: week 12
Concentration of serum amyloid A (SAA)
Blood analysis
Measured: baseline
Concentration of serum amyloid A (SAA)
Blood analysis
Measured: week 12
Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),
Blood analysis
Measured: baseline
Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),
Blood analysis
Measured: week 12
Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)
Blood analysis
Measured: baseline
Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)
Blood analysis
Measured: week 12
Concentration of soluble E-selectin (sE-selectin).
Blood analysis
Measured: baseline
Concentration of soluble E-selectin (sE-selectin).
Blood analysis
Measured: week 12
Vascular endothelial function
Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device
Measured: baseline
Vascular endothelial function
Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device
Measured: week 12
Homeostatic model assessment for insulin resistance (HOMA-IR)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the homeostatic model assessment for insulin resistance (HOMA-IR). The HOMA-IR is calculated from the fasting insulin and glucose concentration.sensitivity and beta cell function. The following parameters are calculated: homeostatic model assessment for insulin resistance, whole-body insulin sensitivity index, insulinogenic index and the area under the curve for glucose and insulin.
Measured: baseline
Homeostatic model assessment for insulin resistance (HOMA-IR)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the homeostatic model assessment for insulin resistance (HOMA-IR). The HOMA-IR is calculated from the fasting insulin and glucose concentration.sensitivity and beta cell function. The following parameters are calculated: homeostatic model assessment for insulin resistance, whole-body insulin sensitivity index, insulinogenic index and the area under the curve for glucose and insulin.
Measured: week 12
Whole-body insulin sensitivity index (ISI)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the whole-body insulin sensitivity index (ISI). The ISI is calculated from both insulin and glucose concentrations.
Measured: baseline
Whole-body insulin sensitivity index (ISI)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the whole-body insulin sensitivity index (ISI). The ISI is calculated from both insulin and glucose concentrations.
Measured: week 12
Area under the curve of insulin concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of insulin concentrations.
Measured: baseline
Area under the curve of insulin concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of insulin concentrations.
Measured: week 12
Area under the curve of glucose concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of glucose concentrations.
Measured: baseline
Area under the curve of glucose concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of glucose concentrations.
Measured: week 12
Insulinogenic index
An oral glucose tolerance test will be performed for assessment of beta cell function by calculation of the insulinogenic index. The insulinogenic index is calculated from both insulin and glucose concentrations.
Measured: baseline
Insulinogenic index
An oral glucose tolerance test will be performed for assessment of beta cell function by calculation of the insulinogenic index. The insulinogenic index is calculated from both insulin and glucose concentrations.
Measured: week 12
Cardiac autonomic function
Cardiac autonomic function will be operationalized as heart rate variability by means of continuous beat-to-beat heart rate signal measurements. time domain and frequency domain analysis of the R-R intervals will be performed
Measured: baseline
Cardiac autonomic function
Cardiac autonomic function will be operationalized as heart rate variability by means of continuous beat-to-beat heart rate signal measurements. time domain and frequency domain analysis of the R-R intervals will be performed
Measured: week 12
Systolic and Diastolic Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer
Measured: baseline
Systolic and Diastolic Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer
Measured: week 12
Oxygen uptake (VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Measured: baseline
Oxygen uptake (VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Measured: week 12
Carbon dioxide output (VCO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VCO2 is collected breath-by-breath and averaged every ten seconds.
Measured: baseline
Carbon dioxide output (VCO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VCO2 is collected breath-by-breath and averaged every ten seconds.
Measured: week 12
Minute ventilation (VE)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE is collected breath-by-breath and averaged every ten seconds.
Measured: baseline
Minute ventilation (VE)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE is collected breath-by-breath and averaged every ten seconds.
Measured: week 12
Equivalents for oxygen uptake (VE/VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VO2 is collected breath-by-breath and averaged every ten seconds.
Measured: baseline
Equivalents for oxygen uptake (VE/VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VO2 is collected breath-by-breath and averaged every ten seconds.
Measured: week 12
Equivalents for carbon dioxide production (VE/VCO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VCO2 is collected breath-by-breath and averaged every ten seconds.
Measured: baseline
Equivalents for carbon dioxide production (VE/VCO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VCO2 is collected breath-by-breath and averaged every ten seconds.
Measured: week 12
Tidal volume (Vt)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis Vt is collected breath-by-breath and averaged every ten seconds.
Measured: baseline
Tidal volume (Vt)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis Vt is collected breath-by-breath and averaged every ten seconds.
Measured: week 12
Breathing frequency (BF)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis BF is collected breath-by-breath and averaged every ten seconds.
Measured: baseline
Breathing frequency (BF)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis BF is collected breath-by-breath and averaged every ten seconds.
Measured: week 12
Respiratory gas exchange ratio (RER)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis RER is collected breath-by-breath and averaged every ten seconds.
Measured: baseline
Respiratory gas exchange ratio (RER)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis RER is collected breath-by-breath and averaged every ten seconds.
Measured: week 12
Heart rate (HR)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of a heart rate monitor the HR is measured and averaged every ten seconds.
Measured: baseline
Heart rate (HR)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of a heart rate monitor the HR is measured and averaged every ten seconds.
Measured: week 12
A six-minute walk test
The covered distance is measured during a six-minute walk test.
Measured: baseline
A six-minute walk test
The covered distance is measured during a six-minute walk test.
Measured: week 12
Relative autonomy index
Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).
Measured: baseline
Relative autonomy index
Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).
Measured: week 12
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Measured: baseline
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Measured: week 12
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Measured: baseline
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 20181 Feb 2021

First posted25 Feb 2019
Study start15 Nov 2018
Primary completion1 Feb 2021
Study completion1 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03853018
Sponsor's protocol ID: CWATLDP-001
Acronym: CWATLDP
Status last verified: Jun 2021
First submitted: 15 Nov 2018
Last updated: 10 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Franssen WMA, Nieste I, Koppo K, Joris P, Vandereyt F, Savelberg HHCM, Eijnde BO. Effects of reducing sedentary behaviour on cardiovascular health, skeletal muscle oxidative capacity and functional exercise capacity in sedentary adults: a randomised controlled trial. BMJ Open Sport Exerc Med. 2026 Mar 18;12(1):e002759. doi: 10.1136/bmjsem-2025-002759. eCollection 2026.
PubMed 41878723
Franssen WMA, Nieste I, Vandereyt F, Savelberg HHCM, Eijnde BO. A 12-week consumer wearable activity tracker-based intervention reduces sedentary behaviour and improves cardiometabolic health in free-living sedentary adults: a randomised controlled trial. J Act Sedentary Sleep Behav. 2022 Dec 1;1(1):8. doi: 10.1186/s44167-022-00007-z.
PubMed 40229981

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
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All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Consumer Wearable Activity Trackers to Reduce Sedentary Behaviour and Improve Health-related Outcomes in Sedentary Adults
ClinicalTrials.gov ID: NCT03853018
Acronym / sponsor ID: CWATLDP / CWATLDP-001
Conditions: Sedentary Lifestyle
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Hasselt UniversityUniversity, hospital or other
Study start: 15 Nov 2018 (actual)
Primary completion: 1 Feb 2021 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 25 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the effectiveness of consumer wearable activity trackers to reduce sedentary behaviour and the impact on cardiometabolic health.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control group	No intervention	–The control group is instructed to continue their habitual daily physical activity patterns and sedentary behaviour
CWAT intervention group	Experimental	Device: CWAT interventionThe CWAT group will receive the activity tracker. Subjects will receive inactivity alerts after 1 hour of inactivity to break up sitting time and avoid prolonged sitting. During the interruptions they will be asked to walk for several minutes.
CWAT + motivation intervention group	Experimental	Device: CWAT intervention, Device: CWAT + motivation intervention groupSubjects randomised into the CWATLDP intervention will receive the activity tracker and will be stimulated with the aid of coaching sessions and goal setting.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Sedentary adults
40-75 years,
<7500steps/day,
sitting time of >10h/day,
BMI 23-30 kg/m2,

Key exclusion criteria (8 listed)

pregnancy,
regularly (>150 min per week during the last four months) engaged in moderate-to-vigorous intensity exercise,
any known contradiction for physical activity,
systolic blood pressure >160mmHg,
diastolic blood pressure >100mmHg

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CWAT interventionParticipant in the intervention group will wear an activity tracker for 12 weeks.	Device	CWAT + motivation intervention group, CWAT intervention group
CWAT + motivation intervention groupParticipant in the intervention group will wear an activity tracker for 12 weeks and are also motivated by the researcher via a lifestyle data platform.	Device	CWAT + motivation intervention group

Primary outcome

Steps per day
Time frame: Baseline
Physical activity will be quantified using the activPAL3™ activity monitor.
sitting time
Time frame: baseline
sedentary behaviour will be quantified using the activPAL3™ activity monitor.
Steps per day
Time frame: week 12
Physical activity will be quantified using the activPAL3™ activity monitor.
sitting time
Time frame: week 12
sedentary behaviour will be quantified using the activPAL3™ activity monitor.

78 secondary outcomes

body weight
Time frame: baseline
body weight
Time frame: week 12
Height
Time frame: baseline
Height
Time frame: week 12
DEXA (Dual Energy X-Ray)
Time frame: baseline
DEXA (Dual Energy X-Ray)
Time frame: week 12
Concentration of glucose
Time frame: baseline
Concentration of glucose
Time frame: week 12
Concentration of Insuline
Time frame: baseline
Concentration of Insuline
Time frame: week 12
Concentration of total cholesterol
Time frame: baseline
total cholesterol
Time frame: week 12
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Time frame: baseline
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Time frame: week 12
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Time frame: baseline
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Time frame: week 12
Concentration of triglyceride
Time frame: baseline
Concentration of triglyceride
Time frame: week 12
Concentration of glycated haemoglobin (HbA1c)
Time frame: baseline
Concentration of glycated haemoglobin (HbA1c)
Time frame: week 12
Concentration of uric acid
Time frame: baseline
Concentration of uric acid
Time frame: week 12
Concentration of interleukin 6 (IL-6),
Time frame: baseline
Concentration of interleukin 6 (IL-6),
Time frame: week 12
Concentration of tumor necrosis factor-alpha (TNF-α),
Time frame: baseline
Concentration of tumor necrosis factor-alpha (TNF-α),
Time frame: week 12
Concentration of C-reactive protein (CRP)
Time frame: baseline
Concentration of C-reactive protein (CRP)
Time frame: week 12
Concentration of serum amyloid A (SAA)
Time frame: baseline
Concentration of serum amyloid A (SAA)
Time frame: week 12
Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),
Time frame: baseline
Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),
Time frame: week 12
Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)
Time frame: baseline
Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)
Time frame: week 12
Concentration of soluble E-selectin (sE-selectin).
Time frame: baseline
Concentration of soluble E-selectin (sE-selectin).
Time frame: week 12
Vascular endothelial function
Time frame: baseline
Vascular endothelial function
Time frame: week 12
Homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: baseline
Homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
Derived from this study: PubMed 41878723Franssen WMA, Nieste I, Koppo K, Joris P, Vandereyt F, Savelberg HHCM, Eijnde BO. Effects of reducing sedentary behaviour on cardiovascular health, skeletal muscle oxidative capacity and functional exercise capacity in sedentary adults: a randomised controlled trial. BMJ Open Sport Exerc Med. 2026 Mar 18;12(1):e002759. doi: 10.1136/bmjsem-2025-002759. eCollection 2026.
Derived from this study: PubMed 40229981Franssen WMA, Nieste I, Vandereyt F, Savelberg HHCM, Eijnde BO. A 12-week consumer wearable activity tracker-based intervention reduces sedentary behaviour and improves cardiometabolic health in free-living sedentary adults: a randomised controlled trial. J Act Sedentary Sleep Behav. 2022 Dec 1;1(1):8. doi: 10.1186/s44167-022-00007-z.

Related trials for Sedentary Lifestyle

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
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Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bert Op 't Eijnde, prof. dr. study chair

Hasselt University

Wouter Franssen, drs. principal investigator

Hasselt University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CWAT intervention and CWAT + motivation intervention group in people with Sedentary Lifestyle, run by Hasselt University at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steps per day (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03853018, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.