|- candidate number||14445|
|- NTR Number||NTR3896|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-feb-2013|
|- Secondary IDs||NL43397.044.014 / P13-06; CCMO|
|- Public Title||Towards a balanced and active lifestyle: Can psychological characteristics be influenced using technology assisted feedback.|
|- Scientific Title||Towards a balanced and active lifestyle: Two experiments to investigate whether Self-efficacy with respect to performance and physical activity can be influenced using technology assisted feedback.|
|- hypothesis||It is hypothesized that including behavioral change theories into the feedback messages of these technology supported services might increase the effectiveness of telemedicine services|
|- Healt Condition(s) or Problem(s) studied||Physical activity, Overweight, Telemedicine |
|- Inclusion criteria||For study 1 and 2:|
1. Capable of reading and writing Dutch;
2. Minimum age of 18 years;
3. BMI higher than 25.
|- Exclusion criteria||For both studies:|
1. Under treatment for severe psychiatric morbidity such as major depression, psychoses, schizophrenia, or drug dependence (both now and in the past);
2. Physical disabilities that limit walking, subjects who use a wheelchair;
3. Pregnancy during the study.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2013|
|- planned closingdate||1-jul-2014|
|- Target number of participants||90|
|- Interventions||For study 1 the intervention will be as follows:|
The participant will be asked to walk from (A) to (B) in exactly X seconds, wearing scuba fins and a blindfold. The number of seconds that the subject has to complete the distance (A) to (B) will differ within, but not between groups. Before each trial, subjects will have to indicate how well they think they are able to execute the task on a scale from 0 to 100, as a measure for their level of Self-Efficacy with respect to the task. Additionally, subjects in group 1 and 2 are told they will receive feedback after completion of each trial in the form of hearing the sound of a cash register (ďka-chingĒ). The participant is told that the closer the participant is to the number of seconds in which the participant needed to complete the distance, the higher the reward at the end of the trial. This will be represented by a higher number of repetitions of the sound of the cash register. Participants are informed that the maximum number of repetitions of the sound is ten times.
For study 2 the intervention will be as follows:
Subjects receive the Ambulant Activity Feedback (AAF) system, which comprises a tri-axial accelerometer and a Personal Digital Assistant (PDA). They will be asked to wear these devices during their everyday life for a total of fourteen days. During the first seven days, users will not receive any feedback; only physical activity is measured. After these seven days, participants come to RRD so that the principal investigator can adjust the AAF's settings according to the participant's assigned condition. After this, the users will wear the system for another seven days. The AAF system provides the user with visual real-time feedback and time-related personalized feedback messages. The visual real-time feedback is a graphical presentation of the cumulative data of the subjectís physical activity pattern over the day. At any time, subjects can consult the display of the PDA to see their current physical activity pattern in relation to their goal pattern. The time-related personalized feedback messages are provided on a time interval set by the principal investigator and will be automatically generated by the PDA based on the difference between the activity pattern of the patient at that moment and the individually tailored goal value that is based on the level of physical activity in the first seven days of measurement. The personalized feedback messages can be concrete advises to become more or less active, or suggestions of preferred activities one can perform to achieve the desired changes. The intervention is based on providing three groups different forms of time-related feedback messages:
1. Personalized feedback messages;
2. Feedback messages as usual;
3. No feedback messages.
Additionally, subjects will be asked to complete two questionnaires before and after the experiment.
|- Primary outcome||The main outcome parameter for study 1) and study 2) is level of Self-efficacy. For study 1), Self-Efficacy will be measured by asking subjects, before each trial, how confident one is that one can execute the required task on a scale of 0 to 100. In study 2), Self-Efficacy will also be measured by the adapted version of the questionnaire by Rodgers et al. Subjects, however, will be asked to answer the questionnaire at two points in time: at the start of the experiment and at the end. |
|- Secondary outcome||The secondary outcome parameters for study 1) are: - Task performance: the number of seconds that the subject deviates from the number of seconds the subject was given to complete the trial. Analyzed as a quantitative variable, using a univariate analysis of variance. - Level of Self-Efficacy at the end of the experiment as measured by the question that subjects have to answer at the start of each trial. - Level of Self-Efficacy as measured by the adapted version of the questionnaire by Rodgers et al. (2008). - Retention rate will be calculated by subtracting the average performance on the retention trials from the average performance on the experimental trials. The differences between groups in retention rate can be investigated using a univariate analysis of variance. The secondary outcome parameters for study 2) are: - Change in activity: the rate of change in physical activity pattern for 30 minutes after a feedback message has been presented to the subject. Our research design only allows for comparing condition 1 and 2, since subjects in group 3 will not receive any feedback messages. Subjects will be asked whether they smoke or not and what their working status is to identify a possible influencing factor (see Appendix 3). - Stage of Change: a one item questionnaire is used to assess a subjectís stage of change. Based on the answer the subject can be categorized in one of five stages: precontemplation, contemplation, preparation, action or maintenance. Subjects will be asked to complete this questionnaire both at the start and the end of the experiment.|
|- Timepoints||April 2013: Spread advertisement / start inclusion;|
July 2013: End experimental trial.
Study one has one timepoint. Study two lasts for fourteen days with a questionnaire before and after the experiment.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. R. Achterkamp|
|- CONTACT for SCIENTIFIC QUERIES||MSc. R. Achterkamp|
|- Sponsor/Initiator ||Roessingh Research and Development b.v.|
(Source(s) of Monetary or Material Support)
|- Brief summary||About 52% of the population has overweight and it is predicted that this will rise even to an even higher percentage in the future. Technology supported services for increasing a healthy lifestyle are upcoming and shown effective in the short run. It is hypothesized that including behavioral change theories into the feedback messages of these technology supported services might increase the effectiveness. It is insufficiently known, however, what aspects to include. Many theories and models from behavioral sciences include the concept of Self-Efficacy, which is also repeatedly associated to physical activity. Therefore, the main focus in the present study is on the questions whether and how to include Self-Efficacy in technology supported services for increasing a healthy lifestyle.
The primary objective is to study the effect of computerized personalised feedback based on behavioural sciences, on a subjectís level of Self-Efficacy. This goal is reached by executing 1) a lab study and 2) a field study. The first study will focus on the effect of different manipulated rewarding strategies on task performance on level of Self-efficacy, in a lab setting. The second study focuses on the effect of personalized feedback messages on level of Self-Efficacy in daily life.
|- Main changes (audit trail)|
|- RECORD||27-feb-2013 - 20-mei-2013|