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

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; General Practice; Primary Care
• Intervention / Treatment: Behavioral: pedometer-plus-email; Behavioral: pedometer-only

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pedometer-plus-email	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.
Active Comparator: pedometer-only	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
average daily step count	change in average daily steps measured during 7-day period at baseline and at 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	measured to the nearest kg	12 weeks
systolic blood pressure	measured to the nearest mmHg	12 weeks
diastolic blood pressure	measured to the nearest mmHg	12 weeks
waist circumference	recorded with a measurement tape to the nearest cm	12 weeks
hip circumference	recorded with a measurement tape to the nearest cm	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
health-related quality of life	assessed with the 36-Item Short Form Health Survey (SF-36)	12 weeks
anxiety	assessed with the anxiety subscale of the Hospital Anxiety and Depression Scale	12 weeks
depression	assessed with the depression subscale of the Hospital Anxiety and Depression Scale	12 weeks
self-efficacy	assessed with the Czech version of the General Self-Efficacy scale	12 weeks

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Tomas Vetrovsky, MD, Charles University, Czech Republic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2015
• Primary Completion (Actual): September 29, 2016
• Study Completion (Actual): December 9, 2016

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Pedometer-plus-email

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No