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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03783611
Other study ID # MyPlan2.0._olderadults
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2016
Est. completion date June 16, 2017

Study information

Verified date May 2019
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The beneficial effects of physical activity (PA) for older adults are well known. Yet, few older adults reach the health guideline of 150 minutes/week of moderate-intensity PA. eHealth interventions are effective in raising PA levels in older adults on the short-term. However, intermediate- or long-term effects have been examined rarely. This study aimed to investigate the effect of the eHealth intervention 'MyPlan 2.0' on both accelerometer-based and self-reported PA levels in Belgian older adults on the short- and intermediate-term.

This study was a randomized controlled trial with three measurement moments (baseline (n=72), post (five weeks after baseline; n=68) and follow-up (three months after baseline; n=68). At all measurement moments, participants in the control group and intervention group filled out the International Physical Activity Questionnaire and wore an accelerometer during one week. Participants in the intervention group got access to the eHealth intervention 'MyPlan 2.0' and used it for five consecutive weeks after baseline. 'MyPlan 2.0' was based on self-regulatory theory and focused on both pre- and post-intentional processes to increase PA.


Description:

Technical information about the content of the MyPlan 2.0. intervention:

MyPlan 2.0. was the eHealth intervention that was used in this study. MyPlan 2.0. is a theory- and user-based intervention. Theories used to develop the intervention are the self-regulation theory and the Health Action Approach model. The intervention targets pre- and post-intentional processes to reach behavior change. The intervention consists of five website visits in five weeks (one per week).

During the first website visit, the participants fill in a short PA questionnaire and based on the answers, they receive personal feedback about their behavior (pre-intentional processes). Knowledge is also provided by giving users the chance to fill in an optional quiz about PA and its beneficial effects. Post-intentional processes are targeted during this first visit by asking the participants to make an action plan. Participants are asked what they want to do (e.g. being more active by cycling during leisure time), when (e.g. every Sunday morning), where (e.g. in the streets nearby) and for how long (e.g. 60 minutes). After answering these questions, the participants can identify difficult situations and possible barriers (i.e. coping planning) while pursuing their goals. Dependent on which barriers they select, specific solutions are given and the participants could choose which ones they consider appropriate and want to apply. After this first website visit, the users can indicate how they want to self-monitor their behaviour (e.g. using an agenda).

One week after finishing the first website visit, the participants receive an email to revisit the website. During this second visit, they receive feedback about their behavioural change process and their goals (e.g. did the participant reach his/her goal or not?). Afterwards the participants have the possibility to adapt their action plan (e.g. setting new, more realistic goals). They can reconsider coping plans, based on barriers they experienced while pursuing their goals. Furthermore, participants can optionally read activity tips. Website visits 3, 4 and 5 are respectively activated one week after the previous visit. Again, the participants are reminded by email. These three last visits are identical to the second visit (review of the action and coping plan).


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 16, 2017
Est. primary completion date June 16, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 80 Years
Eligibility Inclusion Criteria:

- retired

- able to walk 100 meters without assistance

- speak and understand Dutch

- have an email address

Exclusion Criteria:

- severe physical health problems

- not retired

- not able to speak and understand Dutch

- not having an email address

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MyPlan 2.0.
eHealth intervention to increase physical activity in older adults. MyPlan 2.0 consists of five website visits. The first website visit contains pre- and post-intentional processes. The following four website visits contains mainly post-intentional processes. During the first website, participants fill in a questionnaire about their physical activity levels, and receive feedback. Furthermore, they are asked to make an action plan and think about barriers to reach their activity goals and possible solutions to tackle these barriers. During the other four website visits, participants receive feedback about their behavior change process and their action plan (did they reach their goal)? During these website visits, they can adapt their action plans.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Outcome

Type Measure Description Time frame Safety issue
Primary change in accelerometer-based physical activity participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light- intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity. Higher values represent more physical activity. change between baseline and post (5 weeks after baseline)
Primary change in accelerometer-based physical activity participants wear an accelerometer (activity monitor) to objectively measure their physical activity levels. The investigators examine change in total physical activity (sum of light-intensity and moderate-to-vigorous physical activity) and moderate-to-vigorous physical activity. change between baseline and follow-up (3 months after baseline)
Primary change in self-reported physical activity the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different intensities and types of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week. change between baseline and post (5 weeks after baseline)
Primary change in self-reported physical activity the validated International Physical Activity Questionnaire (IPAQ) is used to assess self-reported weekly physical activity in three domains (leisure-time, transport, household). Within each domain, different types and intensities of physical activity are assessed. Minutes per week of physical activity in all subdomains are assessed, namely leisure-time walking, leisure-time moderate physical activity, leisure-time vigorous physical activity, moderate physical activity in the garden, vigorous physical activity in the garden, moderate physical activity at home, walking for transport and cycling for transport. The physical activity data are truncated to realistic maxima based on the official IPAQ guidelines. These guidelines subscribe that the maximum amount of physical activity for each subdomain is maximum 840 minutes per week. change between baseline and follow-up (3 months after baseline)
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