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Physical ActivityNCT04973813

Active Choice Intervention About Physical Activity for Physically Inactive Adults

A study testing Guideline + Active Choice + action&coping planning (GA+), Guideline + Active Choice (GA) and Guideline + information (GI) in people with Physical Activity, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This web-based experimental study aims to ascertain whether promoting an active (i.e. conscious and autonomous) choice process about physical activity results in better behavioural outcomes (e.g. physical activity) and psychological outcomes (e.g. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
Guideline + Active Choice + action&coping planning (GA+), Guideline + Active Choice (GA) and Guideline + information (GI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
564 participants
Where
1 siteNetherlands
Study dates
4 Sep 2020to 9 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Pregnancy
  • Wheelchair user
  • Not being able to walk a minimum of 100 meters

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • VUMedicalCenter

    Amsterdam, North Holland, 1018BT

Other trials in Netherlands

About this study

Official title: Effects of an Active Choice Intervention on Physical Activity Intentions and Behaviour Among Physically Inactive Adults: A Four-Arm Web-Based Experiment

This web-based experimental study aims to ascertain whether promoting an active (i.e. conscious and autonomous) choice process about physical activity results in better behavioural outcomes (e.g. physical activity) and psychological outcomes (e.g. physical activity intention) compared to promoting a passive choice process in physically inactive adults.

Read the 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.

Being tested
Guideline + Active Choice + action&coping planning (GA+), Guideline + Active Choice (GA), Guideline + information (GI), Guideline (G)
Keywords
Physical activity intervention, Active choice, Decision making, Web-based
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guideline + Active Choice + action&coping planning (GA+)Behavioural

    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

  • Guideline + Active Choice (GA)Behavioural

    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.

  • Guideline + information (GI)Behavioural

    Web-based information about the national physical activity guideline, pros and cons of physical activity, and possible barriers to physical activity.

  • Guideline (G)Behavioural

    Also called Comparison arm

    Web-based information about the national physical activity guideline.

Study groups in NCT04973813
Study groupRoleWhat they receive
Guideline + Active Choice + action&coping planning (GA+)ExperimentalParticipants 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.
Receives: Behavioral: Guideline + Active Choice + action&coping planning (GA+)
Guideline + Active Choice (GA)ExperimentalParticipants 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.
Receives: Behavioral: Guideline + Active Choice (GA)
Guideline + Information (GI)ExperimentalParticipants received the national physical activity guideline, and information about pros and cons of physical activity, and possible barriers to physical activity.
Receives: Behavioral: Guideline + information (GI)
Guideline (G)OtherComparison arm. Participants received the national physical activity guideline.
Receives: Behavioral: Guideline (G)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intention

    Intention to become more physically active (yes/no), assessed by a questionnaire

    Measured: Directly after the intervention (Day 0)

  2. Physical activity

    Physical activity levels (MET minutes per week), assessed by the short form of the International Physical Activity Questionnaire (IPAQ)

    Measured: Change from baseline at approximately 18 days

Secondary outcomes (19)

  1. Sitting time

    Sitting time (minutes per day), assessed by the short form of the International Physical Activity Questionnaire (IPAQ)

    Measured: Change from baseline at approximately 18 days

  2. Perceived change in physical activity compared to baseline

    Questionnaire item: Participants' self-perceived change in physical between baseline and follow-up. Dichotomous outcome (change/no change).

    Measured: Change from baseline at approximately 18 days

  3. Intention strength

    Questionnaire item: scale 0 (no strong intention) - 10 (very strong intention). a higher score indicates higher intention strength.

    Measured: Change from day 0, at approximately 18 days

  4. Active choice

    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.

    Measured: Directly after the intervention (Day 0)

  5. Autonomous choice

    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.

    Measured: Directly after the intervention (Day 0)

  6. Commitment

    Commitment to become more physically active; 1 item on a scale of 0 (no commitment) - 10 (high commitment). A higher score indicates higher commitment.

    Measured: Directly after the intervention (Day 0)

  7. Commitment

    Commitment to become more physically active; 1 item on a scale of 0 (no commitment) - 10 (high commitment). A higher score indicates higher commitment.

    Measured: Change from day 0, at approximately 18 days follow-up

  8. Self-efficacy

    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.

    Measured: Directly after the intervention (Day 0)

  9. Self-efficacy

    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.

    Measured: Change from day 0, at approximately 18 days follow-up

  10. Satisfaction about one's plan

    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).

    Measured: Directly after the intervention (Day 0)

  11. Alignment of choice with personal values

    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)

    Measured: Directly after the intervention (Day 0)

  12. Perceived advantages and disadvantages of physical activity

    Open-ended questions about the perceived advantages and disadvantages of one's current physical activity behavior, and of increasing physical activity.

    Measured: During intervention (Day 0)

  13. Value of health

    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)

    Measured: During intervention (Day 0)

  14. Values influencing physical activity

    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.

    Measured: During intervention (Day 0)

  15. Plans to change physical activity

    Open-ended questions about the preferred kind of physical activity, frequency, location, days and start date.

    Measured: During intervention (Day 0)

  16. Perceived barriers to physical activity

    Open-ended question asking about perceived barriers to physical activity

    Measured: During intervention (Day 0)

  17. Plans to cope with perceived barriers

    Open-ended questions about the ways one could cope with each perceived barriers

    Measured: During intervention (Day 0)

  18. Factors supporting physical activity

    Question about the factors that supported or would support physical activity. Multiple choice question.

    Measured: Follow-up; approximately 18 days after the intervention (day 0)

  19. Barriers to physical activity

    Question about the barriers that hindered physical activity in the past two weeks. Multiple choice question.

    Measured: Follow-up; approximately 18 days after the intervention (day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start4 Sep 2020
  3. Primary completion9 Oct 2020
  4. Study completion9 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973813
Sponsor's protocol ID
2020.142
Status last verified
Jul 2021
First submitted
11 Jun 2021
Last updated
22 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to make all anonymized data available during publication, e.g. via clinicaltrials.gov.

Publications

  • Landais LL, Jelsma JGM, Verhagen EALM, Timmermans DRM, Damman OC. Awareness of a disconnect between the value assigned to health and the effort devoted to health increases the intention to become more physically active. Health Psychol Behav Med. 2023 Jul 30;11(1):2242484. doi: 10.1080/21642850.2023.2242484. eCollection 2023.

    PubMed 37529054

  • Landais LL, Damman OC, Jelsma JGM, Verhagen EALM, Timmermans DRM. Promoting an active choice among physically inactive adults: a randomised web-based four-arm experiment. Int J Behav Nutr Phys Act. 2022 Apr 27;19(1):49. doi: 10.1186/s12966-022-01288-y.

    PubMed 35477419

Questions about this trial

What is this clinical trial studying?

A study testing Guideline + Active Choice + action&coping planning (GA+), Guideline + Active Choice (GA) and Guideline + information (GI) in people with Physical Activity, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intention (time frame: Directly after the intervention (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973813, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.

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Clinical Trial NCT04973813 | AzTrials