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

Not Applicable

Completed

• Conditions: Physical Activity; Primary Care; General Practice
• Interventions: Behavioral: pedometer-plus-email; Behavioral: pedometer-only

• Registration Number: NCT03135561
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-12
• Primary Completion: 2016-09-29
• Study Completion: 2016-12-09
• Status Verified: 2017-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Study First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pedometer-plus-email	pedometer-plus-email	-
pedometer-only	pedometer-only	-

Primary Outcome Measures

Name	Time	Method
average daily step count	12 weeks	change in average daily steps measured during 7-day period at baseline and at 12 weeks

Secondary Outcome Measures

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