NCT06823336

Brief Summary

The purpose of this randomized controlled pilot trial is to test the effectiveness of a six-week tailored physical activity program with and without peer mentoring on the psychological constructs and exercise behaviour of inactive undergraduate women. The objectives are to:

  • Quantify the degree to which a peer-mentorship intervention affects exercise motivation determined through three basic psychological needs (i.e., autonomy, competence, and relatedness).
  • Examine general psychological distress and exercise engagement throughout the study.
  • Qualitatively explore participants' experiences following the completion of the program using an open-ended survey to gain a better understanding of its impact. Researchers will compare the parallel arm conditions to see how the inclusion of social support impacts exercise engagement. Participants will be asked to engage in exercise three times a week at the campus gym; those in the intervention condition will have an assigned peer-mentor who will join them for one weekly session and virtually communicate with them between sessions.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

January 28, 2025

Last Update Submit

February 6, 2025

Conditions

Keywords

Exercise psychologyPeer-mentorship programWomens healthPandemic recovery eramixed methodsUndergraduate women

Outcome Measures

Primary Outcomes (2)

  • Psychological Needs Satisfaction in Exercsie Scale

    Participants' exercise motivation, focused on the psychological needs and specific regulations, will be assessed quantitatively using The Psychological Needs Satisfaction in Exercise Scale. This 18-question tool, participants will evaluate each statement based on how it applied to them over the past week on a six-point scale (1= false, 6= true). In this scale, six statements are allotted for each of the three basic needs (e.g., autonomy, competence, and relatedness) in the context of exercise engagement. Subscale scores will be calculated by averaging the six items assigned to each basic psychological need, with higher scores being more indicative of greater self-determination and lower of less.

    During enrollment at baseline, after week 3, and at the end of the study at week 6

  • Behavioural Regulation in Exercise Questionnaire- 3

    This questionnaire will be used to to gauge where an individual falls on the six-point motivational continuum, as it relates to exercise engagement. This will be assessed quantitatively using the Behavioural Regulation in Exercise Questionnaire-3, as participants will evaluate each statement based on how it applied to them over the past week. The 24-questions in this measure operate on a five-point Likert scale (0= not true for me, 2= sometimes true for me, 4= very true for me). In this questionnaire, four statements have been allocated for each of the six types of regulation/motivation (e.g., motivation, introjected regulation, identified regulation, integrated regulation, intrinsic regulation, external regulation). Subscale scores will be calculated by averaging the six items assigned to each basic psychological need, with higher scores being more indicative of greater intrinsic motivation and lower of greater extrinsic motivation.

    During enrollment at baseline, after week 3, and at the end of the study at week 6

Secondary Outcomes (5)

  • Depression Anxiety Stress Scale- Short Form

    During enrollment at baseline, following week 3, and at the end of the study at week 6

  • Exercise Tracking- Gym location

    From enrollment to the end of the program at 6 weeks

  • Exercise Tracking- Duration

    From enrollment to the end of the program at 6 weeks

  • Exercise Tracking- Workout Details

    From enrollment to the end of the program at 6 weeks

  • Exercise Tracking- Frequency

    From enrollment to the end of the program at 6 weeks

Other Outcomes (7)

  • Qualitative Experiential Accounts- Open Ended Questionnaire

    Findings will be collected upon completion of the program, at the end of week 6.

  • Facility Usage Data- Frequency

    From enrollment to the end of the program at 6 weeks

  • Communication Data- Frequency

    From enrollment to the end of the program at 6 weeks

  • +4 more other outcomes

Study Arms (2)

Exercise plus mentor

EXPERIMENTAL

Participants will be encouraged to engage in independent exercise twice a week for 30 minutes. They will be randomly assigned to a peer-mentor, with whom they will engage in on-on-one exercise once a week for 30 minutes. Between sessions, they will engage in virtual communication with each other for about 30 minutes each week. Each participant-mentor duo will continue this protocol for 6-weeks.

Other: Intervention

Exercise alone

ACTIVE COMPARATOR

Participants will be encouraged to engage in exercise three times a week for thirty minutes, over a span of 6-weeks.

Other: Control

Interventions

Participants will be encouraged to engage in independent exercise twice a week for 30 minutes. They will be randomly assigned to a peer-mentor, with whom they will engage in on-on-one exercise once a week for 30 minutes. Between sessions, they will engage in virtual communication with each other for about 30 minutes each week. Each participant-mentor duo will continue this protocol for 6-weeks.

Also known as: Social support
Exercise plus mentor
ControlOTHER

Participants will be encouraged to engage in exercise three times a week for thirty minutes, over a span of 6-weeks.

Also known as: Exercise alone
Exercise alone

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGirls/women have historically engaged in less exercise than those of boys/men at all ages, a trend that largely worsens in young adulthood. Post-removal of pandemic precautions, the exercise habits of undergraduate women disproportionately decreased as compared to those of men. Thus, a need to focus on this population and provide them with a gender specific exercise program to meet their unique needs exists.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Identify as a woman
  • Full-time undergraduate student at Lakehead University
  • Classified as an exercise initiate (e.g., report one or fewer bouts of exercise per week)
  • Reported an absence of health risks that would interfere with exercise engagement as determined by the Get Active Questionnaire
  • Able to commute to Lakehead's campus
  • Want to become more active
  • Have access to online technology (e.g., email, zoom)
  • Can speak, read, and write in English fluently

You may not qualify if:

  • Identify as a man
  • Not enrolled as a full-time undergraduate student at Lakehead University
  • Report the presence of health risks that would interfere with exercise engagement
  • Meet the national physical activity guidelines (e.g., 150 minutes of moderate to vigorous exercise per week)
  • Unable to commute to campus
  • Lack of access to technology
  • Not fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B 5E1, Canada

RECRUITING

Related Publications (2)

  • DeShaw KJ, Lansing JE, Perez ML, Ellingson LD, Welk GJ. Effects of a peer health coaching program on college student lifestyle behaviors. J Am Coll Health. 2024 Dec;72(9):3330-3337. doi: 10.1080/07448481.2022.2155473. Epub 2023 Jan 3.

    PMID: 36595662BACKGROUND
  • Keeler, L. A., Skidmore, B., Leenstra, T., MacDonald, J. R., & Stewart, D. (2021). Treating university students' depression using physical activity with peers: Two field-based quasi-experiments grounded in the self-determination theory. Journal of College Student Psychotherapy, 35(3), 205-223. https://doi.org/10.1080/87568225.2019.1660293

    BACKGROUND

MeSH Terms

Interventions

MethodsExercise

Intervention Hierarchy (Ancestors)

Investigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Erin S Pearson, PhD

    Lakehead University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline MSc Student

CONTACT

Erin S Pearson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The student researcher will be masked to the two conditions during the participant's orientation session (e.g., facility tour, baseline data collection) and will only reveal their condition using a numbered opaque sealed envelope immediately following data collection. The participant will be asked to hold this allocation in confidence and initiative contact with their mentor to schedule the first workout session.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will include two conditions: an intervention (exercise plus mentor) and a control (exercise only) condition. Both groups will be encouraged to engage in exercise at least three times a week for 30 minutes at the campus facilities for 6-weeks. The intervention group will additionally engage in one-on-one exercise at the campus facilities once a week with their randomly assigned peer mentor and virtually communicate between sessions. Thus, intervention participants will be engaging in independent exercise at least twice a week. Those assigned to the control condition will only engage in independent exercise at least three times a week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 12, 2025

Study Start

January 28, 2025

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations