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Completed

NCT Number: NCT03135561

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

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.

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Key information

Conditions

Physical Activity Behavior General Practice Motor Activity Primary Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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-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.

Primary outcomes

  1. average daily step count

    Time frame: 12 weeks

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

Secondary outcomes

  1. body weight

    Time frame: 12 weeks

    measured to the nearest kg

  2. systolic blood pressure

    Time frame: 12 weeks

    measured to the nearest mmHg

  3. diastolic blood pressure

    Time frame: 12 weeks

    measured to the nearest mmHg

  4. waist circumference

    Time frame: 12 weeks

    recorded with a measurement tape to the nearest cm

  5. hip circumference

    Time frame: 12 weeks

    recorded with a measurement tape to the nearest cm

Other outcomes

  1. health-related quality of life

    Time frame: 12 weeks

    assessed with the 36-Item Short Form Health Survey (SF-36)

  2. anxiety

    Time frame: 12 weeks

    assessed with the anxiety subscale of the Hospital Anxiety and Depression Scale

  3. depression

    Time frame: 12 weeks

    assessed with the depression subscale of the Hospital Anxiety and Depression Scale

  4. self-efficacy

    Time frame: 12 weeks

    assessed with the Czech version of the General Self-Efficacy scale

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 1, 2017
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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