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Clinical Trials/NCT03135561
NCT03135561
Completed
Not Applicable

A Pedometer-based Walking Intervention With and Without Email Counselling in General Practice: a Pilot Randomised Controlled Trial

Charles University, Czech Republic0 sites37 target enrollmentNovember 12, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
Charles University, Czech Republic
Enrollment
37
Primary Endpoint
average daily step count
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

A two-arm parallel randomised controlled trial comparing pedometer-based intervention with and without email counselling in a primary care setting. Physically inactive patients from four general practices will be randomised to the pedometer-plus-email group or to the pedometer-alone group. All patients will be instructed to gradually increase the daily number of steps to at least 10,000. Patients in the pedometer-plus-email group will receive 8 counselling emails based on behavioural techniques. The primary outcome will be change in average daily steps measured during 7-day period at baseline and at 12 weeks.

Registry
clinicaltrials.gov
Start Date
November 12, 2015
End Date
December 9, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Charles University, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Tomáš Větrovský

PhD Student

Charles University, Czech Republic

Eligibility Criteria

Inclusion Criteria

  • physically inactive, i.e. takes less than 8,000 steps per day at baseline
  • registered at the participating general practice,
  • over 18 years of age,
  • regular email user, and willing to use email for the purpose of the study,
  • has a home computer with access to the Internet.

Exclusion Criteria

  • medical or psychiatric condition which the general practitioner considers as inappropriate for participating in the intervention (e.g., terminal illness, psychotic illness, chronic disorders or diseases that seriously influence the ability to be physically active, dementia or significant cognitive impairment, unable to move about independently),
  • medical, personal of family condition which the general practitioner considers temporarily affects mean daily step count at baseline (e.g., acute illness, holiday or business trip),
  • pregnant woman,
  • currently engaging in regular sports or exercise (at least twice a week),
  • failure to upload pedometer data to a website at baseline assessment,
  • failure to give informed consent with the study.

Outcomes

Primary Outcomes

average daily step count

Time Frame: 12 weeks

change in average daily steps measured during 7-day period at baseline and at 12 weeks

Secondary Outcomes

  • hip circumference(12 weeks)
  • diastolic blood pressure(12 weeks)
  • body weight(12 weeks)
  • waist circumference(12 weeks)
  • systolic blood pressure(12 weeks)

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