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Completed

NCT Number: NCT03799146

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

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.

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Key information

Conditions

Overweight Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Social Behavior

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Movement and Sports Sciences

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have access to internet
  • Being computer literate

Exclusion criteria

  • non Dutch speaking

Treatment and study plan

MyPlan 2.0

Behavioral

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.

Waiting List

Other

Waiting List control group

Primary outcomes

  1. Change in objective total, light and moderate-to-vigorous physical activity (PA)

    Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)

    Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers

  2. Change in objective sedentary behaviour

    Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)

    Change in amount of total sitting time, measured via accelerometers

  3. 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.

    Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)

    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.

  4. Change in self-reported sedentary behaviour

    Time frame: Pretest, posttest (6 weeks) and follow-up (6 months)

    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.

Secondary outcomes

  1. Change in self-efficacy

    Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

    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.

  2. Change in outcome expectancies

    Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

    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.

  3. Change in risk perception

    Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

    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

  4. Change in intention

    Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

    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.

  5. Change in action planning

    Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

    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.

  6. Change in coping planning

    Time frame: Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months

    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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Dec 6, 2021

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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