NCT03853018

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

November 15, 2018

Last Update Submit

June 9, 2021

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (4)

  • Steps per day

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

    Baseline

  • sitting time

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

    baseline

  • Steps per day

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

    week 12

  • sitting time

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

    week 12

Secondary Outcomes (78)

  • body weight

    baseline

  • body weight

    week 12

  • Height

    baseline

  • Height

    week 12

  • DEXA (Dual Energy X-Ray)

    baseline

  • +73 more secondary outcomes

Study Arms (3)

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.

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.

Device: CWAT interventionDevice: CWAT + motivation intervention group

Interventions

CWAT interventionDEVICE

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

CWAT + motivation intervention groupCWAT intervention group
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.

CWAT + motivation intervention group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary adults
  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 40229981DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bert Op 't Eijnde, prof. dr.

    Hasselt University

    STUDY CHAIR

  • Wouter Franssen, drs.

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2018

First Posted

February 25, 2019

Study Start

November 15, 2018

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

BE(1)