NCT06843161

Brief Summary

Physical inactivity is considered a global pandemic negatively impacting the health of over 60% of older adults in America. Interventions aimed at improving physical activity in older adults focus on training reflective processes such as providing information on health benefits of physical activity. These interventions generally find that participants improved their intentions to be physically active rather than supporting actual change in behaviours to become physically active. There is growing support for the idea that human behaviour is the result of a combination of quick automatic processes and slower reflective processes. Interventional studies have used cognitive bias modification tasks that target the quick automatic processes to retrain participant's bias. Such studies find that participant's bias towards diet, alcohol, and phobias can be altered using these cognitive bias modification tasks. In this study, the investigators developed a new training task using a robotic device that aims to retrain automatic bias towards physical activity and sedentary behaviours. The robotic device allows greater immersive environments for participants to interact with and be more engaged with the cognitive bias modification task. This interventional study is testing whether this new robot-based training and the protocol for assessing physical activity is feasible for retraining older adults' bias towards physical activity and sedentary behaviour. Participants will be examined on their daily physical activity using an accelerometer, their physical ability using functional tests, and their perceptions on physical activity using questionnaires. To determine whether this protocol is feasible, the investigators will examine participant recruitment and retention rates.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

February 7, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

February 7, 2025

Last Update Submit

February 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determinants of Protocol Feasibility: Recruitment Rate and Retention Rate

    The main purpose of this study is to determine whether the intervention protocol is feasible and thus the primary outcomes are recruitment rates, retention rates, and reasons for study dropout.

    From enrollment to the end of recruitment at 7 months

Secondary Outcomes (7)

  • Actigraph wGT3X-BT accelerometers for measuring daily step count

    From enrollment to the end of recruitment at 7 months

  • Approach Avoidance Task

    From enrollment to the end of recruitment at 7 months

  • 6 Minute Walk Test

    From enrollment to the end of recruitment at 7 months

  • Hand Dynamometer for Grip Strength

    From enrollment to the end of recruitment at 7 months

  • World Health Organization Quality of Life Questionnaire (WHOQOL)

    From enrollment to the end of recruitment at 7 months

  • +2 more secondary outcomes

Study Arms (2)

Interventional Group: Responses Biased towards Visual Stimulus

EXPERIMENTAL

Successfully recruited individuals will be performing the JOGGNG Task on the Kinarm Endpoint Laboratory. This task requires participants to quickly make a reaching movement to manipulate a virtual avatar that is jogging across a field. During this, a frisbee will move towards the avatar and will tilt clockwise or counterclockwise. Participants have been instructed to either reach quickly to grab the frisbee from the air during clockwise tilts or to not move during counterclockwise tilts. This tilt/movement associated is reversed to control for potential bias in tilt angle and movement. An image of physical activity or sedentary behaviour will appear inside of the frisbee but participants are not told that it is associated with any of the tilts. For the Interventional Group, the tilt associated with movement will have an image of physical activity appear 90% of the time and the tilt associated with no movement will have an image of sedentary behaviour 90% of the time.

Device: The jog or ground go no go task for retraining automatic bias

Control Group: Responses Randomly Assigned to Visual Stimulus

SHAM COMPARATOR

Recruited participants will be performing the JOGGNG Task on the Kinarm Endpoint Laboratory. This task requires participants to quickly make a reaching movement to manipulate a virtual avatar that is jogging across a field. During this, a frisbee will move towards the avatar and will tilt clockwise or counterclockwise. Participants have been instructed to either reach quickly to grab the frisbee from the air during clockwise tilts or to not move during counterclockwise tilts. This tilt/movement associated is reversed to control for potential bias in tilt angle and movement. An image of physical activity or sedentary behaviour will appear inside of the frisbee but participants are not told that it is associated with any of the tilts. For the Control Group, the tilt associated with movement will have an image of physical activity appear 50% of the time and the tilt associated with no movement will have an image of sedentary behaviour 50% of the time.

Device: The jog or ground go no go task for retraining automatic bias

Interventions

Recruited participants will be performing the JOGGNG Task on the Kinarm Endpoint Laboratory. This task requires participants to control a robotic handle to manipulate a virtual avatar that looks as if it is jogging across a field. During the jogging, a frisbee will appear and quickly move towards the avatar, eventually tilting clockwise or counterclockwise. Participants are required to either reach quickly to grab the frisbee from the air during clockwise tilts or to not move during counterclockwise tilts. This tilt/movement associated is reversed to control for a potential bias in tilt angle and movement. An image of physical activity or sedentary behaviour will appear inside of the frisbee but participants are not told that it is associated with any of the tilts. Each trial consists of one frisbee and participants will complete a total of 3 blocks of 360 trials each which will take approximately 30 minutes to complete.

Control Group: Responses Randomly Assigned to Visual StimulusInterventional Group: Responses Biased towards Visual Stimulus

Eligibility Criteria

Age60 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAny and all self-identified genders are permitted to join this study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Able to walk
  • Able to communicate in English
  • Able to travel to the University of Ottawa Lees Campus

You may not qualify if:

  • Diagnosed neurological or psychiatric disorder
  • Impaired motor function of the upper limbs
  • Unable to understand task instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Ottawa, Ontario, K1S5S9, Canada

RECRUITING

Related Publications (10)

  • Veling, H., Becker, D., Liu, H., Quandt, J., & Holland, R. W. How go/no-go training changes behavior: A value-based decision-making perspective. Current Opinion in Behavioral Sciences. 2022;47:101206.

    BACKGROUND
  • Scott SH. Apparatus for measuring and perturbing shoulder and elbow joint positions and torques during reaching. J Neurosci Methods. 1999 Jul 15;89(2):119-27. doi: 10.1016/s0165-0270(99)00053-9.

    PMID: 10491942BACKGROUND
  • Rhodes RE, McEwan, D, Rebar AL. Theories of physical activity behavior change: A history and synthesis of approaches. Psychology of Sport and Exercise. 2019;42:100-9.

    BACKGROUND
  • Marteau TM, Hollands GJ, Fletcher PC. Changing human behavior to prevent disease: the importance of targeting automatic processes. Science. 2012 Sep 21;337(6101):1492-5. doi: 10.1126/science.1226918.

    PMID: 22997327BACKGROUND
  • Conroy DE, Hyde AL, Doerksen SE, Ribeiro NF. Implicit attitudes and explicit motivation prospectively predict physical activity. Ann Behav Med. 2010 May;39(2):112-8. doi: 10.1007/s12160-010-9161-0.

    PMID: 20140542BACKGROUND
  • Chevance G, Bernard P, Chamberland PE, Rebar A. The association between implicit attitudes toward physical activity and physical activity behaviour: a systematic review and correlational meta-analysis. Health Psychol Rev. 2019 Sep;13(3):248-276. doi: 10.1080/17437199.2019.1618726. Epub 2019 Jun 12.

    PMID: 31117901BACKGROUND
  • Cheval B, Tipura E, Burra N, Frossard J, Chanal J, Orsholits D, Radel R, Boisgontier MP. Avoiding sedentary behaviors requires more cortical resources than avoiding physical activity: An EEG study. Neuropsychologia. 2018 Oct;119:68-80. doi: 10.1016/j.neuropsychologia.2018.07.029. Epub 2018 Jul 26.

    PMID: 30056055BACKGROUND
  • Cheval B, Sarrazin P, Isoard-Gautheur S, Radel R, Friese M. Reflective and impulsive processes explain (in)effectiveness of messages promoting physical activity: a randomized controlled trial. Health Psychol. 2015 Jan;34(1):10-9. doi: 10.1037/hea0000102. Epub 2014 Aug 18.

    PMID: 25133840BACKGROUND
  • Cheval B, Boisgontier MP. The Theory of Effort Minimization in Physical Activity. Exerc Sport Sci Rev. 2021 Jul 1;49(3):168-178. doi: 10.1249/JES.0000000000000252.

    PMID: 34112744BACKGROUND
  • Aulbach MB, Knittle K, Haukkala A. Implicit process interventions in eating behaviour: a meta-analysis examining mediators and moderators. Health Psychol Rev. 2019 Jun;13(2):179-208. doi: 10.1080/17437199.2019.1571933. Epub 2019 Feb 6.

    PMID: 30676235BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorBias, Implicit

Condition Hierarchy (Ancestors)

BehaviorPrejudiceSocial Behavior

Study Officials

  • Kayne Park, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR
  • Matthieu P Boisgontier, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayne Park, PhD

CONTACT

Matthieu Boisgontier, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 24, 2025

Study Start

March 1, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

All data from participants that were included in the final study report will be shared on an online repository.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
The IPD and supporting information will be available for an indefinite time on an online repository once the data collection is complete.
Access Criteria
All data of participants with full datasets collected in this study will be accessible after the data collection has completed.

Locations