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

NCT03135561 | Completed

• 1 other identifier: Pedometer-plus-email
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• average daily step count

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

  12 weeks

Secondary Outcomes (5)

• body weight

  12 weeks

• systolic blood pressure

  12 weeks

• diastolic blood pressure

  12 weeks

• waist circumference

  12 weeks

• hip circumference

  12 weeks

Other Outcomes (4)

• health-related quality of life

  12 weeks

• anxiety

  12 weeks

• depression

  12 weeks

Study Arms (2)

pedometer-plus-email

EXPERIMENTAL

Behavioral: pedometer-plus-email

pedometer-only

ACTIVE COMPARATOR

Behavioral: pedometer-only

Interventions

pedometer-plus-email 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-plus-email

pedometer-only 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.

pedometer-only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Related Publications (1)

• 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.

  PMID: 29769107 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Tomas Vetrovsky, MD

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: November 12, 2015
• Primary Completion: September 29, 2016
• Study Completion: December 9, 2016
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share