NCT04973813

Brief 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. physical activity intention) compared to promoting a passive choice process in physically inactive adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
564

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

June 11, 2021

Last Update Submit

July 12, 2021

Conditions

Keywords

Physical activity interventionActive choiceDecision makingWeb-based

Outcome Measures

Primary Outcomes (2)

  • Intention

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

    Directly after the intervention (Day 0)

  • Physical activity

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

    Change from baseline at approximately 18 days

Secondary Outcomes (19)

  • Sitting time

    Change from baseline at approximately 18 days

  • Perceived change in physical activity compared to baseline

    Change from baseline at approximately 18 days

  • Intention strength

    Change from day 0, at approximately 18 days

  • Active choice

    Directly after the intervention (Day 0)

  • Autonomous choice

    Directly after the intervention (Day 0)

  • +14 more secondary outcomes

Study Arms (4)

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

EXPERIMENTAL

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.

Behavioral: Guideline + Active Choice + action&coping planning (GA+)

Guideline + Active Choice (GA)

EXPERIMENTAL

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.

Behavioral: Guideline + Active Choice (GA)

Guideline + Information (GI)

EXPERIMENTAL

Participants received the national physical activity guideline, and information about pros and cons of physical activity, and possible barriers to physical activity.

Behavioral: Guideline + information (GI)

Guideline (G)

OTHER

Comparison arm. Participants received the national physical activity guideline.

Behavioral: Guideline (G)

Interventions

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 + action&coping planning (GA+)

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 + Active Choice (GA)

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

Guideline + Information (GI)
Guideline (G)BEHAVIORAL

Web-based information about the national physical activity guideline.

Also known as: Comparison arm
Guideline (G)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VUMedicalCenter

Amsterdam, North Holland, 1018BT, Netherlands

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Guidelines as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Danielle Timmermans, Prof. dr.

    Amsterdam UMC

    STUDY DIRECTOR
  • Evert Verhagen, Prof. dr.

    Amsterdam UMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2021

First Posted

July 22, 2021

Study Start

September 4, 2020

Primary Completion

October 9, 2020

Study Completion

October 9, 2020

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

We plan to make all anonymized data available during publication, e.g. via clinicaltrials.gov.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will become available during publication.
Access Criteria
No access restrictions.

Locations