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Completed

NCT Number: NCT03853018

Effectiveness of Activity Trackers to Reduce Sedentary Behaviour in Sedentary Adults

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

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Key information

Conditions

Sedentary Lifestyle Behavior Sedentary Behavior

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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%

Exclusion criteria

  • 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.

Treatment and study plan

CWAT intervention

Device

Participant in the intervention group will wear an activity tracker for 12 weeks.

CWAT + motivation intervention group

Device

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.

Primary outcomes

  1. Steps per day

    Time frame: Baseline

    Physical activity will be quantified using the activPAL3™ activity monitor.

  2. sitting time

    Time frame: baseline

    sedentary behaviour will be quantified using the activPAL3™ activity monitor.

  3. Steps per day

    Time frame: week 12

    Physical activity will be quantified using the activPAL3™ activity monitor.

  4. sitting time

    Time frame: week 12

    sedentary behaviour will be quantified using the activPAL3™ activity monitor.

Secondary outcomes

  1. body weight

    Time frame: baseline

    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

  2. body weight

    Time frame: week 12

    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

  3. Height

    Time frame: baseline

    Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot

  4. Height

    Time frame: week 12

    Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot

  5. DEXA (Dual Energy X-Ray)

    Time frame: baseline

    body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry

  6. DEXA (Dual Energy X-Ray)

    Time frame: week 12

    body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry

  7. Concentration of glucose

    Time frame: baseline

    Blood analysis

  8. Concentration of glucose

    Time frame: week 12

    Blood analysis

  9. Concentration of Insuline

    Time frame: baseline

    Blood analysis

  10. Concentration of Insuline

    Time frame: week 12

    Blood analysis

  11. Concentration of total cholesterol

    Time frame: baseline

    Blood analysis

  12. total cholesterol

    Time frame: week 12

    Blood analysis

  13. Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Time frame: baseline

    Blood analysis

  14. Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Time frame: week 12

    Blood analysis

  15. Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Time frame: baseline

    Blood analysis

  16. Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Time frame: week 12

    Blood analysis

  17. Concentration of triglyceride

    Time frame: baseline

    Blood analysis

  18. Concentration of triglyceride

    Time frame: week 12

    Blood analysis

  19. Concentration of glycated haemoglobin (HbA1c)

    Time frame: baseline

    Blood analysis

  20. Concentration of glycated haemoglobin (HbA1c)

    Time frame: week 12

    Blood analysis

  21. Concentration of uric acid

    Time frame: baseline

    Blood analysis

  22. Concentration of uric acid

    Time frame: week 12

    Blood analysis

  23. Concentration of interleukin 6 (IL-6),

    Time frame: baseline

    Blood analysis

  24. Concentration of interleukin 6 (IL-6),

    Time frame: week 12

    Blood analysis

  25. Concentration of tumor necrosis factor-alpha (TNF-α),

    Time frame: baseline

    Blood analysis

  26. Concentration of tumor necrosis factor-alpha (TNF-α),

    Time frame: week 12

    Blood analysis

  27. Concentration of C-reactive protein (CRP)

    Time frame: baseline

    Blood analysis

  28. Concentration of C-reactive protein (CRP)

    Time frame: week 12

    Blood analysis

  29. Concentration of serum amyloid A (SAA)

    Time frame: baseline

    Blood analysis

  30. Concentration of serum amyloid A (SAA)

    Time frame: week 12

    Blood analysis

  31. Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),

    Time frame: baseline

    Blood analysis

  32. Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),

    Time frame: week 12

    Blood analysis

  33. Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)

    Time frame: baseline

    Blood analysis

  34. Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)

    Time frame: week 12

    Blood analysis

  35. Concentration of soluble E-selectin (sE-selectin).

    Time frame: baseline

    Blood analysis

  36. Concentration of soluble E-selectin (sE-selectin).

    Time frame: week 12

    Blood analysis

  37. Vascular endothelial function

    Time frame: baseline

    Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device

  38. Vascular endothelial function

    Time frame: week 12

    Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device

  39. Homeostatic model assessment for insulin resistance (HOMA-IR)

    Time frame: baseline

    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.

  40. Homeostatic model assessment for insulin resistance (HOMA-IR)

    Time frame: week 12

    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.

  41. Whole-body insulin sensitivity index (ISI)

    Time frame: baseline

    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.

  42. Whole-body insulin sensitivity index (ISI)

    Time frame: week 12

    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.

  43. Area under the curve of insulin concentrations

    Time frame: baseline

    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.

  44. Area under the curve of insulin concentrations

    Time frame: week 12

    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.

  45. Area under the curve of glucose concentrations

    Time frame: baseline

    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.

  46. Area under the curve of glucose concentrations

    Time frame: week 12

    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.

  47. Insulinogenic index

    Time frame: baseline

    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.

  48. Insulinogenic index

    Time frame: week 12

    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.

  49. Cardiac autonomic function

    Time frame: baseline

    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

  50. Cardiac autonomic function

    Time frame: week 12

    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

  51. Systolic and Diastolic Blood pressure

    Time frame: baseline

    Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer

  52. Systolic and Diastolic Blood pressure

    Time frame: week 12

    Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer

  53. Oxygen uptake (VO2)

    Time frame: baseline

    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.

  54. Oxygen uptake (VO2)

    Time frame: week 12

    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.

  55. Carbon dioxide output (VCO2)

    Time frame: baseline

    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.

  56. Carbon dioxide output (VCO2)

    Time frame: week 12

    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.

  57. Minute ventilation (VE)

    Time frame: baseline

    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.

  58. Minute ventilation (VE)

    Time frame: week 12

    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.

  59. Equivalents for oxygen uptake (VE/VO2)

    Time frame: baseline

    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.

  60. Equivalents for oxygen uptake (VE/VO2)

    Time frame: week 12

    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.

  61. Equivalents for carbon dioxide production (VE/VCO2)

    Time frame: baseline

    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.

  62. Equivalents for carbon dioxide production (VE/VCO2)

    Time frame: week 12

    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.

  63. Tidal volume (Vt)

    Time frame: baseline

    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.

  64. Tidal volume (Vt)

    Time frame: week 12

    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.

  65. Breathing frequency (BF)

    Time frame: baseline

    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.

  66. Breathing frequency (BF)

    Time frame: week 12

    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.

  67. Respiratory gas exchange ratio (RER)

    Time frame: baseline

    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.

  68. Respiratory gas exchange ratio (RER)

    Time frame: week 12

    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.

  69. Heart rate (HR)

    Time frame: baseline

    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.

  70. Heart rate (HR)

    Time frame: week 12

    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.

  71. A six-minute walk test

    Time frame: baseline

    The covered distance is measured during a six-minute walk test.

  72. A six-minute walk test

    Time frame: week 12

    The covered distance is measured during a six-minute walk test.

  73. Relative autonomy index

    Time frame: baseline

    Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).

  74. Relative autonomy index

    Time frame: week 12

    Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).

  75. Total calorie intake

    Time frame: baseline

    Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.

  76. Total calorie intake

    Time frame: week 12

    Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.

  77. Macronutrient content

    Time frame: baseline

    Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.

  78. Macronutrient content

    Time frame: week 12

    Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study title

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

Acronym: CWATLDP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2019
Registry last updated
Jun 10, 2021

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

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

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

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