- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04973813
Active Choice Intervention About Physical Activity for Physically Inactive Adults
Effects of an Active Choice Intervention on Physical Activity Intentions and Behaviour Among Physically Inactive Adults: A Four-Arm Web-Based Experiment
Study Overview
Status
Conditions
Detailed Description
In this web-based experimental study, the investigators will use a pre-test post-test four-arm parallel design to compare the effect of promoting an active choice process versus a passive choice process about physical activity on behavioural outcomes (e.g. physical activity behaviour, perceived increase in physical activity) and psychological outcomes (e.g. physical activity intention, commitment) among physically inactive adults.
Participants will be randomized to one of four groups. Participants in group GA+ will be encouraged to make a very active choice by weighing advantages and disadvantages of physical activity, considering personal values, identifying barriers and engaging in action and coping planning. The intervention for group GA is similar, but lacks the action and coping planning exercises. In the other two groups, a passive choice process will be promoted by only providing information: Group G will read the national physical activity guideline and group GI will read the guideline and information about possible advantages and disadvantages and barriers to physical activity. Behavioural and psychological outcomes will be assessed at the first measurement and follow-up measurement. Regression analyses will be performed to examine intergroup differences. In addition, sensitivity analyses and a process evaluation will be performed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1018BT
- VUMedicalCenter
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Low levels of physical activity (i.e. physically active for at least 30 minutes on <5 days a week and engaging in <150 minutes of physical activity in total throughout an average week)
Exclusion Criteria:
- Pregnancy
- Wheelchair user
- Not being able to walk a minimum of 100 meters
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guideline + Active Choice + action&coping planning (GA+)
Participants received a web-based intervention consisting of information (including the national physical activity guideline) and several assignments.
Assignments included: completing a decision balance sheet; indicating the importance of personal values and the time, effort and energy spent on these personal values; action planning; identifying barriers to physical activity; coping planning.
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Web-based intervention consisting of information and assignments, including: completing a decision balance sheet; indicating the importance of personal values and the time, effort and energy spent on these personal values; action planning; identifying barriers to physical activity; coping planning
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Experimental: Guideline + Active Choice (GA)
Participants received a web-based intervention consisting of information (including the national physical activity guideline) and several assignments.
Assignments included: completing a decision balance sheet; indicating the importance of personal values and the time, effort and energy spent on these personal values; identifying barriers to physical activity.
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Web-based intervention consisting of information and several assignments, including: completing a decision balance sheet; indicating the importance of personal values and the time, effort and energy spent on these personal values; identifying barriers to physical activity.
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Experimental: Guideline + Information (GI)
Participants received the national physical activity guideline, and information about pros and cons of physical activity, and possible barriers to physical activity.
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Web-based information about the national physical activity guideline, pros and cons of physical activity, and possible barriers to physical activity.
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Other: Guideline (G)
Comparison arm.
Participants received the national physical activity guideline.
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Web-based information about the national physical activity guideline.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention
Time Frame: Directly after the intervention (Day 0)
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Intention to become more physically active (yes/no), assessed by a questionnaire
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Directly after the intervention (Day 0)
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Physical activity
Time Frame: Change from baseline at approximately 18 days
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Physical activity levels (MET minutes per week), assessed by the short form of the International Physical Activity Questionnaire (IPAQ)
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Change from baseline at approximately 18 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sitting time
Time Frame: Change from baseline at approximately 18 days
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Sitting time (minutes per day), assessed by the short form of the International Physical Activity Questionnaire (IPAQ)
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Change from baseline at approximately 18 days
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Perceived change in physical activity compared to baseline
Time Frame: Change from baseline at approximately 18 days
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Questionnaire item: Participants' self-perceived change in physical between baseline and follow-up.
Dichotomous outcome (change/no change).
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Change from baseline at approximately 18 days
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Intention strength
Time Frame: Change from day 0, at approximately 18 days
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Questionnaire item: scale 0 (no strong intention) - 10 (very strong intention).
a higher score indicates higher intention strength.
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Change from day 0, at approximately 18 days
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Active choice
Time Frame: Directly after the intervention (Day 0)
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Degree to which an active choice is made; a composite score of 9 items on a scale of 1 (totally not agree) - 5 (totally agree); a higher score indicates a more active choice.
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Directly after the intervention (Day 0)
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Autonomous choice
Time Frame: Directly after the intervention (Day 0)
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Degree to which an autonomous choice is made; 2 items on a scale of 1 - 10.
For the first item, a higher score indicates a more autonomous choice, whereas for the second item, a higher score indicates a less autonomous choice.
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Directly after the intervention (Day 0)
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Commitment
Time Frame: Directly after the intervention (Day 0)
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Commitment to become more physically active; 1 item on a scale of 0 (no commitment) - 10 (high commitment).
A higher score indicates higher commitment.
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Directly after the intervention (Day 0)
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Commitment
Time Frame: Change from day 0, at approximately 18 days follow-up
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Commitment to become more physically active; 1 item on a scale of 0 (no commitment) - 10 (high commitment).
A higher score indicates higher commitment.
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Change from day 0, at approximately 18 days follow-up
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Self-efficacy
Time Frame: Directly after the intervention (Day 0)
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Self-efficacy to become more physically active; 2 items on a scale of 1 (no self-efficacy) - 10 (high self-efficacy).
A higher score indicates more self-efficacy.
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Directly after the intervention (Day 0)
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Self-efficacy
Time Frame: Change from day 0, at approximately 18 days follow-up
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Self-efficacy to become more physically active; 2 items on a scale of 1 (no self-efficacy) - 10 (high self-efficacy).
A higher score indicates more self-efficacy.
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Change from day 0, at approximately 18 days follow-up
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Satisfaction about one's plan
Time Frame: Directly after the intervention (Day 0)
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Degree of satisfaction with one's plan to become or not become more physically active on a scale of 1 (no satisfaction) to 10 (high satisfaction).
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Directly after the intervention (Day 0)
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Alignment of choice with personal values
Time Frame: Directly after the intervention (Day 0)
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Extent to which one's plan to become/ not become more physically active corresponds with what one considers important; 1 item on a scale of 1 (no alignment) - 10 (high alignment)
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Directly after the intervention (Day 0)
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Perceived advantages and disadvantages of physical activity
Time Frame: During intervention (Day 0)
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Open-ended questions about the perceived advantages and disadvantages of one's current physical activity behavior, and of increasing physical activity.
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During intervention (Day 0)
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Value of health
Time Frame: During intervention (Day 0)
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Importance of the value 'health', on a scale of 1 (not important at all) to 10 (very important), and the time, effort and energy spent on health on a scale of 1 (no time, effort and energy) to 10 (very much time, effort and energy)
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During intervention (Day 0)
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Values influencing physical activity
Time Frame: During intervention (Day 0)
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The extent to which the following values impact one's physical activity levels on a scale of 1 (no influence) to 10 (high influence): responsibility, achievement, pleasure, family, friendships, balance.
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During intervention (Day 0)
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Plans to change physical activity
Time Frame: During intervention (Day 0)
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Open-ended questions about the preferred kind of physical activity, frequency, location, days and start date.
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During intervention (Day 0)
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Perceived barriers to physical activity
Time Frame: During intervention (Day 0)
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Open-ended question asking about perceived barriers to physical activity
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During intervention (Day 0)
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Plans to cope with perceived barriers
Time Frame: During intervention (Day 0)
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Open-ended questions about the ways one could cope with each perceived barriers
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During intervention (Day 0)
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Factors supporting physical activity
Time Frame: Follow-up; approximately 18 days after the intervention (day 0)
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Question about the factors that supported or would support physical activity.
Multiple choice question.
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Follow-up; approximately 18 days after the intervention (day 0)
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Barriers to physical activity
Time Frame: Follow-up; approximately 18 days after the intervention (day 0)
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Question about the barriers that hindered physical activity in the past two weeks.
Multiple choice question.
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Follow-up; approximately 18 days after the intervention (day 0)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Danielle Timmermans, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study Director: Evert Verhagen, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020.142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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