Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Older Adults

Study Overview
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Brief Summary
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The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.

Detailed Description
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The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group. Both groups will be tested during three testing waves: pretest, posttest and follow-up test. Only the intervention group will be given acces to 'MyPlan 2.0'. 'MyPlan 2.0' consists of a website and mobile application targeting physical activity and sedentary behaviour. The intervention has a duration of five weeks.

Official Title
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A Randomized Controlled Trial to Identify the Effect and the Working Mechanisms of MyPlan 2.0, a Self-regulation-based e- and mHealth Intervention Targeting Physical Activity and Sedentary Behaviour, in Older Adults

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: MyPlan 2.0
* Other: Waiting List


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have access to internet Being computer literate Exclusion Criteria: non Dutch speaking

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with two groups: intervention group and waiting-list control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will receive the e- and mHealth intervention 'MyPlan 2.0'. | Behavioral: MyPlan 2.0<br>* MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring.<br>|
| Experimental: Waiting List control group<br>Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases. | Other: Waiting List<br>* Waiting List control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective total, light and moderate-to-vigorous physical activity (PA) | Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers | Pretest, posttest (6 weeks) and follow-up (6 months) | 
| Change in objective sedentary behaviour | Change in amount of total sitting time, measured via accelerometers | Pretest, posttest (6 weeks) and follow-up (6 months) | 
| Change in self-reported total, moderate and moderate-to-vigorous physical activity (PA) as well as total work-related, transport-related, household-related and leisure time PA. | Change in amount of total, light and moderate-to-vigorous PA well as total work-related, transport-related, household-related and leisure time PA will be measured via the International Physical Activity Questionnaire (IPAQ). The IPAQ measures physical activity in four domains: work, transport, household and leisure time. Higher scores indicate higher levels of physical activity. For each scale the minimum value is 0. We will use the method described by Dubuy et al. (2013) to truncate the data. | Pretest, posttest (6 weeks) and follow-up (6 months) | 
| Change in self-reported sedentary behaviour | Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire. The total score is calculated by summing all 10 items.The minimum value is 0 and the maximum value is 24 hours. However, data will be truncated at 16 hours. | Pretest, posttest (6 weeks) and follow-up (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-efficacy | Change in amount of self-efficacy to change behaviour, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score. | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months) | 
| Change in outcome expectancies | Outcome expectancies regarding the behaviour change, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score. | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | 
| Change in risk perception | Risk perception about the behaviour, measured via 4 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the four items will be considered the final score | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | 
| Change in intention | Amount of intention to change the behaviour, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score. | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | 
| Change in action planning | Amount of action planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score. | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | 
| Change in coping planning | Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score. | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, physical activity, sedentary behaviour, eHealth, self-regulation, behaviour change techniques