A Pedometer-based Intervention With and Without Email Counselling in General Practice

NCT ID: NCT03135561

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-12
• Study Completion Date: 2016-12-09

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.

Conditions

Physical Activity; Primary Care; General Practice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

pedometer-plus-email

Group Type: EXPERIMENTAL

pedometer-plus-email

Intervention Type: BEHAVIORAL

After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. During the intervention period, patients will receive 8 counselling emails based on behavioural techniques.

pedometer-only

Group Type: ACTIVE_COMPARATOR

pedometer-only

Intervention Type: BEHAVIORAL

After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. There will be no further interaction during the intervention period unless they fail to upload data, in which case they will be offered technical support.

Interventions

pedometer-only

After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. There will be no further interaction during the intervention period unless they fail to upload data, in which case they will be offered technical support.

Intervention Type: BEHAVIORAL

pedometer-plus-email

After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. During the intervention period, patients will receive 8 counselling emails based on behavioural techniques.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Tomáš Větrovský

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomas Vetrovsky, MD

Role: PRINCIPAL_INVESTIGATOR

Charles University, Czech Republic

References

Vetrovsky T, Cupka J, Dudek M, Kuthanova B, Vetrovska K, Capek V, Bunc V. A pedometer-based walking intervention with and without email counseling in general practice: a pilot randomized controlled trial. BMC Public Health. 2018 May 16;18(1):635. doi: 10.1186/s12889-018-5520-8.

Reference Type: DERIVED

PMID: 29769107 (View on PubMed)

Other Identifiers

Pedometer-plus-email

Identifier Type: -

Identifier Source: org_study_id