Effectiveness of Activity Trackers to Reduce Sedentary Behaviour in Sedentary Adults

NCT ID: NCT03853018

Last Updated: 2021-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2021-02-01

Brief Summary

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

Detailed Description

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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

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Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

The control group is instructed to continue their habitual daily physical activity patterns and sedentary behaviour

Group Type NO_INTERVENTION

No interventions assigned to this group

CWAT intervention group

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.

Group Type EXPERIMENTAL

CWAT intervention

Intervention Type DEVICE

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

CWAT + motivation intervention group

Subjects randomised into the CWATLDP intervention will receive the activity tracker and will be stimulated with the aid of coaching sessions and goal setting.

Group Type EXPERIMENTAL

CWAT intervention

Intervention Type DEVICE

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

CWAT + motivation intervention group

Intervention Type 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.

Interventions

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CWAT intervention

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

Intervention Type DEVICE

CWAT + motivation intervention group

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Bert Op't Eijnde

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bert Op 't Eijnde, prof. dr.

Role: STUDY_CHAIR

Hasselt University

Wouter Franssen, drs.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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Hasselt University

Diepenbeek, Limburg, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 40229981 (View on PubMed)

Other Identifiers

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CWATLDP-001

Identifier Type: -

Identifier Source: org_study_id

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