Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007721

Trial Description

start of 1:1-Block title

Title

SMS reminders to increase accelerometer wear-time: A within-trial RCT comparing persuasive messages

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A persistent problem in the primary outcomes of physical activity (PA) interventions is obtaining a realistic picture of the amount and type of physical activity people engage in. The measurements should be done objectively because people have trouble remembering or correctly assessing their activities accurately - this means wearing a device to record their activity overcomes these problems.

We conduct this trial as a sub-study of a PA intervention. In our case, the device is taken off when going to sleep or swimming/showering, so the participants have to remember to put the device on when waking up and returning from the swim/shower. If they forget, their activity data is left unrecorded, and forgetting was the main reason of not wearing the device in our feasibility study.

This study aims to help participants remember the device, which should lead to better evaluation of their physical activity and thus more reliable conclusions. In the social influence literature, reasons and rationale are often touted as highly important means of obtaining compliance, although their effect has not been thoroughly researched. In our study, we will give the participants opportunity to receive text message reminders; one group will receive a succinct message and another will receive a message additionally containing an reason to comply. We then evaluate whether the effect of the two types of messages on wearing behavior differs and whether receiving the messages is associated with wearing behavior.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This study is a within-trial RCT embedded in a larger intervention. We aim to investigate the efficacy of two different SMS messages to increase the wear time of an accelerometer, i.e. provide valid activity data (days of ≥10 hours of activity data and wear hours).

Research questions:
1. Does offering reasons in SMS reminders affect the number of accelerometer wear days, compared to a reminder only?
Limited evidence indicates that providing study participants with reasons might increase compliance, while on the other hand our limited pre-testing suggests preference towards succinct messages.
2. Is receiving SMS reminders associated with accelerometer wear time?
Anecdotal evidence from our feasibility study indicates that forgetting was the main reason for non-adherence. The current study will test this by comparing the adherence rates in a) participants who opt in on the reminders b) participants who opt out on the reminders (non-randomised control group) and c) participants in the feasibility study (historical control group).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007721
  •   2015/04/14
  •   [---]*
  •   yes
  •   Approved
  •   201310238 , Ministry of Social Affairs and Health (Finland)
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Accelerometer wear time
  •   Feasibility of SMS reminders as a means to improve accelerometer wear time.
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Succinct reminder condition: “Good morning! Remember to put on the activity monitor. Thanks!”. Reminder sent on six consecutive mornings.
  •   Reminder and rational justification: “Good morning! Because the data gathered will help produce very important scientific knowledge, remember to put on the activity monitor. Thanks!”. Reminder sent on six consecutive mornings.
  •   A non-randomised control group of participants who decide to opt out of reminders.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control, Historical, No treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1. The number of days on which participants wear the accelerometer, i.e.: provide valid activity data (days of ≥10 hours of activity data).
2. Total wear-time.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Feasibility of using SMS and SMS content acceptability as a part of an RCT, measured with a survey asking about satisfaction with SMS content and fidelity to the intervention (how often the SMS was opened and read in the morning). We also hypothesize the arm receiving reasons to comply would have lower dropout rates in the main study.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Finland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/01/11
  •   230
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   15   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Vocational school student taking part in the Let's Move It RCT.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Not filling the inclusion criterion.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Helsinki University
    • P.O. Box 54
    • 00014  Helsinki
    • Finland
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   +35802941 24881
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Helsinki University
    • Mr.  B.Soc.Sc., BBA  Matti  Heino 
    • P.O. Box 54
    • 00014  Helsinki
    • Finland
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Helsinki University
    • Mr.  B.Soc.Sc, BBA  Matti  Heino 
    • P.O. Box 54
    • 00014  Helsinki
    • Finland
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Ministry of Education and Culture (Finland); ref. 34/626/2012
    • Meritullinkatu 10
    • 00023  Helsinki
    • Finland
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.