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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135561
• Other study ID #: Pedometer-plus-email
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: April 26, 2017
• Start date: November 12, 2015
• Est. completion date: December 9, 2016

Study information

• Verified date: April 2017
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 9, 2016
• Est. primary completion date: September 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• General Practice
• Physical Activity
• Primary Care

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	health-related quality of life	assessed with the 36-Item Short Form Health Survey (SF-36)	12 weeks
Other	anxiety	assessed with the anxiety subscale of the Hospital Anxiety and Depression Scale	12 weeks
Other	depression	assessed with the depression subscale of the Hospital Anxiety and Depression Scale	12 weeks
Other	self-efficacy	assessed with the Czech version of the General Self-Efficacy scale	12 weeks
Primary	average daily step count	change in average daily steps measured during 7-day period at baseline and at 12 weeks	12 weeks
Secondary	body weight	measured to the nearest kg	12 weeks
Secondary	systolic blood pressure	measured to the nearest mmHg	12 weeks
Secondary	diastolic blood pressure	measured to the nearest mmHg	12 weeks
Secondary	waist circumference	recorded with a measurement tape to the nearest cm	12 weeks
Secondary	hip circumference	recorded with a measurement tape to the nearest cm	12 weeks