Social Support (Formal and Informal)SHINENCT06823336
The Supporting Her In Navigating Exercise Program: Examining Peer Support to Promote Exercise Among Undergraduate Women
A study testing Intervention in people with Social Support (Formal and Informal), run by Lakehead University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Social Support (Formal and Informal)
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Lakehead University
Thunder Bay, Ontario, P7B 5E1
Madeline Fabiano, MSc (candidate), 8073552204, mmfabian@lakeheadu.ca
Erin Pearson, PhD, 807-343-8010 ext. 8481, erin.pearson@lakeheadu.ca
About this study
Official title: The SHINE (Supporting Her In Navigating Exercise) Program: A Pilot Study Examining Peer Support as an Exercise Promotion Tool Among Undergraduate Women Initiates
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.
Read more
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.
Read the detailed description
This study aims to explore the use of social support as an exercise promotion tool among undergraduate women who don't exercise or who do so occasionally.
Senior undergraduate and graduate women at Lakehead University were recruited as study mentors for this research project. These individuals were required to have a health background with expertise in physical activity, engage in 150 minutes of exercise per week, be familiar with the university's fitness facility, and be willing to help others become more active. Once confirmed, mentors were trained via a two-hour workshop, focusing on program roles and responsibilities, motivational strategies, physical activity structuring, and communication/confidentiality guidelines.
For participants to be considered eligible, they need to engage in , once deemed eligible via an eligibility questionnaire, all participants will engage in a baseline orientation session. During this session, they will meet with the student researcher in a private room in the C.J. Sanders Fieldhouse at Lakehead University. During this meeting, the duo will review the information letter/participant rights, and if in agreement, the participant will provide informed consent. Once this occurs, the participant will complete a baseline survey that includes a number of measures (e.g., demographic questions, Depression Anxiety Stress Scale, Behavioural Regulation in Exercise Questionnaire, and Psychological Needs Satisfaction in Exercise Questionnaire), and have their height and weight recorded. They will then create a confidential Strava account, to enable exercise tracking and friend the SHINE Program account. Following this, participants will receive a facility tour, where the student researcher will show them around the campus fitness facility and demonstrate how to use some equipment in each space. Once the facility tour is completed, the student researcher will select a sequentially numbered opaque envelope sealed by the research team, indicating which condition the participant will be assigned to. Participants assigned to the exercise condition will be invited to ask questions as their orientation has concluded, while intervention participants will review communication guidelines, create a GroupMe account, and be assigned to a mentor based on mutual availability.
All participants in this study will be asked to engage in exercise three times a week for 30 minutes at the campus gym facility. Individuals assigned to the intervention condition will be joined by their peer-mentor in one of these sessions once a week and be asked to engage in virtual communications in between sessions.
This will continue for 6-weeks, with additional data collection occurring at weeks 3 and 6. Upon completion of the study at week 6, participants will be asked to complete an open-ended exit questionnaire to explore their program experiences.
- Conditions
- Social Support (Formal and Informal)
- Being tested
- Intervention, Control
- Keywords
- Exercise psychology, Peer-mentorship program, Womens health, Pandemic recovery era, mixed methods, Undergraduate women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Also called Social support
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.
ControlOther
Also called Exercise alone
Participants will be encouraged to engage in exercise three times a week for thirty minutes, over a span of 6-weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Participants' general psychological distress will be quantitatively measured through the Depression Anxiety Stress Scale- Short Form. The 21-question scale operates on a four-point Likert scale (0= never, 1= sometimes, 2= often, 3= almost always), and asks participants to evaluate each statement based on how it applied to them over the past week. In this scale, seven questions were allotted to each of the three categories (e.g., depression, anxiety, and stress). When scoring the DASS-21, the scores for each of the three categories are independently summed to gain a final score, with higher scores being indicative of severe psychological distress and lower scores suggest average or typical symptoms.
Measured: During enrollment at baseline, following week 3, and at the end of the study at week 6
Exercise Tracking- Gym location
Participants' exercise engagement will be measured via a virtual exercise monitoring platform, Strava. Participants will upload their workouts each week, revealing the area of the gym they used (e.g., Hangar, Wolf Den, Basement).
Measured: From enrollment to the end of the program at 6 weeks
Exercise Tracking- Duration
Participants' exercise engagement will be measured via a virtual exercise monitoring platform, Strava. Participants will upload their workouts each week, revealing the duration of their session.
Measured: From enrollment to the end of the program at 6 weeks
Exercise Tracking- Workout Details
Participants' exercise engagement will be measured via a virtual exercise monitoring platform, Strava. Participants will upload their workouts each week, revealing the type of workout they engaged in (e.g., cardio, upper body strength, lower body strength, full body strength training).
Measured: From enrollment to the end of the program at 6 weeks
Exercise Tracking- Frequency
Participants' exercise engagement will be measured via a virtual exercise monitoring platform, Strava. Participants will upload their workouts each week, revealing the number of sessions they engage in each week.
Measured: From enrollment to the end of the program at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start28 Jan 2025
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social Support (Formal and Informal)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), St. Joseph's Care Group
- Responsible party
- Principal investigator, Erin Pearson, Lakehead University
- Investigators
- Erin S Pearson, PhD, Principal investigator, Lakehead University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823336
- Sponsor's protocol ID
- 195012
- Acronym
- SHINE
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decision has been made thus far. The research team will decide once the data collection period is completed, based on the number of participants who complete the study.
Publications
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.
PubMed 36595662Keeler, 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SHINE (Supporting Her In Navigating Exercise) Program: A Pilot Study Examining Peer Support as an Exercise Promotion Tool Among Undergraduate Women Initiates
- ClinicalTrials.gov ID
- NCT06823336
- Acronym / sponsor ID
- SHINE / 195012
- Conditions
- Social Support (Formal and Informal)
- Keywords
- Exercise psychology, Peer-mentorship program, Womens health, Pandemic recovery era, mixed methods, Undergraduate women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), St. Joseph's Care Group
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to explore the use of social support as an exercise promotion tool among undergraduate women who don't exercise or who do so occasionally.
Senior undergraduate and graduate women at Lakehead University were recruited as study mentors for this research project. These individuals were required to have a health background with expertise in physical activity, engage in 150 minutes of exercise per week, be familiar with the university's fitness facility, and be willing to help others become more active. Once confirmed, mentors were trained via a two-hour workshop, focusing on program roles and responsibilities, motivational strategies, physical activity structuring, and communication/confidentiality guidelines.
For participants to be considered eligible, they need to engage in , once deemed eligible via an eligibility questionnaire, all participants will engage in a baseline orientation session. During this session, they will meet with the student researcher in a private room in the C.J. Sanders Fieldhouse at Lakehead University. During this meeting, the duo will review the information letter/participant rights, and if in agreement, the participant will provide informed consent. Once this occurs, the participant will complete a baseline survey that includes a number of measures (e.g., demographic questions, Depression Anxiety Stress Scale, Behavioural Regulation in Exercise Questionnaire, and Psychological Needs Satisfaction in Exercise Questionnaire), and have their height and weight recorded. They will then create a confidential Strava account, to enable exercise tracking and friend the SHINE Program account. Following this, participants will receive a facility tour, where the student researcher will show them around the campus fitness facility and demonstrate how to use some equipment in each space. Once the facility tour is completed, the student researcher will select a sequentially numbered opaque envelope sealed by the research team, indicating which condition the participant will be assigned to. Participants assigned to the exercise condition will be invited to ask questions as their orientation has concluded, while intervention participants will review communication guidelines, create a GroupMe account, and be assigned to a mentor based on mutual availability.
All participants in this study will be asked to engage in exercise three times a week for 30 minutes at the campus gym facility. Individuals assigned to the intervention condition will be joined by their peer-mentor in one of these sessions once a week and be asked to engage in virtual communications in between sessions.
This will continue for 6-weeks, with additional data collection occurring at weeks 3 and 6. Upon completion of the study at week 6, participants will be asked to complete an open-ended exit questionnaire to explore their program experiences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise plus mentor | Experimental | Other: InterventionParticipants 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. |
| Exercise alone | Active comparator | Other: ControlParticipants will be encouraged to engage in exercise three times a week for thirty minutes, over a span of 6-weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Social supportParticipants 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 | Exercise plus mentor |
| ControlAlso: Exercise aloneParticipants will be encouraged to engage in exercise three times a week for thirty minutes, over a span of 6-weeks. | Other | Exercise alone |
Primary outcome
Psychological Needs Satisfaction in Exercsie Scale
Time frame: During enrollment at baseline, after week 3, and at the end of the study at week 6
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.
Behavioural Regulation in Exercise Questionnaire- 3
Time frame: During enrollment at baseline, after week 3, and at the end of the study at week 6
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.
5 secondary outcomes
Depression Anxiety Stress Scale- Short Form
Time frame: During enrollment at baseline, following week 3, and at the end of the study at week 6
Exercise Tracking- Gym location
Time frame: From enrollment to the end of the program at 6 weeks
Exercise Tracking- Duration
Time frame: From enrollment to the end of the program at 6 weeks
Exercise Tracking- Workout Details
Time frame: From enrollment to the end of the program at 6 weeks
Exercise Tracking- Frequency
Time frame: From enrollment to the end of the program at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 36595662DeShaw 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.
- BackgroundKeeler, 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
- Individual participant dataSharing planned: Undecided. No decision has been made thus far. The research team will decide once the data collection period is completed, based on the number of participants who complete the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin S Pearson, PhD principal investigator
Lakehead University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Social Support (Formal and Informal), run by Lakehead University at 1 site in Canada.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline MSc Student (807-632-7022, mmfabian@lakeheadu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Needs Satisfaction in Exercsie Scale (time frame: During enrollment at baseline, after week 3, and at the end of the study at week 6). 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 NCT06823336, 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 12 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.