Physical ActivityGUMNCT03567200
Girls United on the Move: A Unique Integrated Physical Activity and Psychosocial Program for At-risk Adolescent Girls
A study testing Single-Arm Feasibility in people with Physical Activity, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this project is to evaluate the effectiveness of a 9-week psycho-social and physical activity program aimed at improving body image, physical self-perceptions, and self-compassion for at-risk adolescent girls. Read more about this study
- Who is it for?
- Ages 11 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Single-Arm Feasibility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2018to 30 May 2019
- 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 11 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants who identify with experiencing challenges with personal or family lives.
- Must identify as female between the ages of 11-15 years of age.
Who cannot join
- No specific exclusion criteria, however, only girls that are specifically identified and invited to join GUM by the school guidance counsellors, at the participating middle schools, will be invited to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A League of Their Own: Examining the Effectiveness of a Psycho-social and Sport Program Targeting At-risk Adolescent Girls
The purpose of this project is to evaluate the effectiveness of a 9-week psycho-social and physical activity program aimed at improving body image, physical self-perceptions, and self-compassion for at-risk adolescent girls. In collaboration with the Elizabeth Fry Society, the GUM program will be delivered to at-risk adolescent girls within the Okanagan Region. Information will be gathered concerning program content and delivery, as well as insights into the participants' experiences with the program. These results will provide much needed information about whether programs integrating psychological, social, and physical components of health are beneficial for this population.
Read the detailed description
Body dissatisfaction increases throughout adolescence; strong associations have been established between body image emotions and negative self--perceptions, reduced self-compassion, low self- esteem, and depression in adolescent girls. This is heightened in at--risk adolescent girls, including those of low socioeconomic status, who have experienced abuse and who have limited social support. As such, unique strategies aimed at reducing negative self--perceptions of one's physical self and improving self- compassion among at--risk adolescent girls are needed. Engagement in physical activity is one way in which adolescent girls may experience positive self--perceptions, enhanced body image emotions, and increased self--compassion, yet the research has primarily focused on girls who are already involved in organized physical activities (i.e., athletes). To address this need, the research team and representatives from the Central Okanagan Elizabeth Fry Society, a National charitable organisation dedicated to advancing the safety, legal rights, and economic security of women and children, have co--created the unique 9- week Girls United and on the Move (GUM) integrated program (psycho-social and physical activity) to improve physical self--perception, body image, and self--compassion among at--risk adolescent girls living in the Okanagan Region of British Columbia. This is particularly important in the Okanagan where there is a high number of adolescent girls from low income, abusive households, with many facing sexual exploitation and extreme despair, compared to other adolescent girls in British Columbia. Thus, the current aim is to implement and undertake a comprehensive evaluation of the program's effectiveness in terms of physical self--perceptions, body image, self--compassion, and commitment to and enjoyment of physical activity, in order to refine and deliver the program more widely.
This 9- week, integrated program will be implemented in up to 8 middle schools throughout the Okanagan. It includes a 1.5 hour, weekly session held at local schools and facilitated by a trained researcher and registered social worker. These sessions include psycho-social components (e.g., understanding healthy relationships, building self--confidence) in addition to engaging in various physical activities (e.g., soccer, dance, and martial arts). At--risk adolescent girls from the participating schools will be identified and recruited by school counsellors. Each school group will include 10- to 12 participants, yielding a total sample of approximately 80-100.
- Conditions
- Physical Activity
- Being tested
- Single-Arm Feasibility
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Arm FeasibilityBehavioural
Also called Girls United and On the Move (GUM) Intervention
Participants in each of the 8 participating groups (N=10-12 per group) are exposed to an integrated intervention program (integration of physical activity and psychosocial components). Each session is co-facilitated by a trained research staff member and a registered social worker, providing participants with the opportunity to engage in physical activity behaviours as well as discuss various psychosocial topics that are applicable to the participants interests. Physical activities include participating in group activities such as rock climbing, self-defence, yoga, etc. Psychosocial topics addressed include group discussions around cyber-bullying, sexual abuse and exploitation, gender issues, etc.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Feasibility | Experimental | 9-week, 1x/week, 90-minute face-to-face sessions. Receives: Behavioral: Single-Arm Feasibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Image
Measured using the Physical Self-Description Questionnaire (PSDQ), which is a multidimensional tool used to measure physical self--perceptions, body image and self--concept. The purpose of the PSDQ is to see how people describe themselves physically.
Measured: Assessing change from baseline to post-intervention (9-weeks).
Self-Compassion
Measured using the Self-Compassion Scale (SCS), which is a a valid and reliable 26--item scale that has previously been used in this population.
Measured: Assessing change from baseline to post-intervention (9-weeks).
Physical Self-Perceptions
Measured using the Physical Self-Description Questionnaire (PSDQ), which is a multidimensional tool used to measure physical self--perceptions, body image and self--concept. The purpose of the PSDQ is to see how people describe themselves physically.
Measured: Assessing change from baseline to post-intervention (9-weeks).
Secondary outcomes (2)
Sport Enjoyment and Commitment
Measured using the Sport-Commitment Questionnaire, which is a 58-item questionnaire that addresses five components or sub-scales which are believed to impact sport commitment; this includes sport enjoyment, involvement alternatives, personal investments, social constraints, and involvement opportunities. Not only has this construct been shown to be very important in motivating youth in sport, but it also may indicate the positive affect to commitment in youth sport programs.
Measured: Assessing change from baseline to post-intervention (9-weeks).
Participant satisfaction and acceptability of the GUM program
Assessed by conducting semi-structured interviews to gather information concerning program content and delivery, as well as insights into their experiences with the program.
Measured: Post-Intervention (9-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start10 Jan 2018
- Primary completion29 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada
- Responsible party
- Principal investigator, Cristina Caperchione, University of British Columbia
- Investigators
- Cristina Caperchione, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567200
- Sponsor's protocol ID
- H17-01540
- Acronym
- GUM
- Status last verified
- Oct 2019
- First submitted
- 15 May 2018
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caperchione CM, Hargreaves N, Sabiston CM, Berg S, Kowalski KC, Ferguson LJ. Exploring the Effectiveness of an Integrated Physical Activity and Psychosocial Program Targeting At-Risk Adolescent Girls: Protocol for the Girls United and on the Move (GUM) Intervention Study. JMIR Res Protoc. 2020 Jun 9;9(6):e15302. doi: 10.2196/15302.
PubMed 32515748
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A League of Their Own: Examining the Effectiveness of a Psycho-social and Sport Program Targeting At-risk Adolescent Girls
- ClinicalTrials.gov ID
- NCT03567200
- Acronym / sponsor ID
- GUM / H17-01540
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 25 Jun 2018 (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 project is to evaluate the effectiveness of a 9-week psycho-social and physical activity program aimed at improving body image, physical self-perceptions, and self-compassion for at-risk adolescent girls. In collaboration with the Elizabeth Fry Society, the GUM program will be delivered to at-risk adolescent girls within the Okanagan Region. Information will be gathered concerning program content and delivery, as well as insights into the participants' experiences with the program. These results will provide much needed information about whether programs integrating psychological, social, and physical components of health are beneficial for this population.
Detailed description
Body dissatisfaction increases throughout adolescence; strong associations have been established between body image emotions and negative self--perceptions, reduced self-compassion, low self- esteem, and depression in adolescent girls. This is heightened in at--risk adolescent girls, including those of low socioeconomic status, who have experienced abuse and who have limited social support. As such, unique strategies aimed at reducing negative self--perceptions of one's physical self and improving self- compassion among at--risk adolescent girls are needed. Engagement in physical activity is one way in which adolescent girls may experience positive self--perceptions, enhanced body image emotions, and increased self--compassion, yet the research has primarily focused on girls who are already involved in organized physical activities (i.e., athletes). To address this need, the research team and representatives from the Central Okanagan Elizabeth Fry Society, a National charitable organisation dedicated to advancing the safety, legal rights, and economic security of women and children, have co--created the unique 9- week Girls United and on the Move (GUM) integrated program (psycho-social and physical activity) to improve physical self--perception, body image, and self--compassion among at--risk adolescent girls living in the Okanagan Region of British Columbia. This is particularly important in the Okanagan where there is a high number of adolescent girls from low income, abusive households, with many facing sexual exploitation and extreme despair, compared to other adolescent girls in British Columbia. Thus, the current aim is to implement and undertake a comprehensive evaluation of the program's effectiveness in terms of physical self--perceptions, body image, self--compassion, and commitment to and enjoyment of physical activity, in order to refine and deliver the program more widely.
This 9- week, integrated program will be implemented in up to 8 middle schools throughout the Okanagan. It includes a 1.5 hour, weekly session held at local schools and facilitated by a trained researcher and registered social worker. These sessions include psycho-social components (e.g., understanding healthy relationships, building self--confidence) in addition to engaging in various physical activities (e.g., soccer, dance, and martial arts). At--risk adolescent girls from the participating schools will be identified and recruited by school counsellors. Each school group will include 10- to 12 participants, yielding a total sample of approximately 80-100.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Feasibility | Experimental | Behavioral: Single-Arm Feasibility9-week, 1x/week, 90-minute face-to-face sessions. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants who identify with experiencing challenges with personal or family lives.
- Must identify as female between the ages of 11-15 years of age.
Key exclusion criteria (1 listed)
- No specific exclusion criteria, however, only girls that are specifically identified and invited to join GUM by the school guidance counsellors, at the participating middle schools, will be invited to participate in the research.
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 |
|---|---|---|
| Single-Arm FeasibilityAlso: Girls United and On the Move (GUM) InterventionParticipants in each of the 8 participating groups (N=10-12 per group) are exposed to an integrated intervention program (integration of physical activity and psychosocial components). Each session is co-facilitated by a trained research staff member and a registered social worker, providing participants with the opportunity to engage in physical activity behaviours as well as discuss various psychosocial topics that are applicable to the participants interests. Physical activities include participating in group activities such as rock climbing, self-defence, yoga, etc. Psychosocial topics addressed include group discussions around cyber-bullying, sexual abuse and exploitation, gender issues, etc. | Behavioural | Single-Arm Feasibility |
Primary outcome
Body Image
Time frame: Assessing change from baseline to post-intervention (9-weeks).
Measured using the Physical Self-Description Questionnaire (PSDQ), which is a multidimensional tool used to measure physical self--perceptions, body image and self--concept. The purpose of the PSDQ is to see how people describe themselves physically.
Self-Compassion
Time frame: Assessing change from baseline to post-intervention (9-weeks).
Measured using the Self-Compassion Scale (SCS), which is a a valid and reliable 26--item scale that has previously been used in this population.
Physical Self-Perceptions
Time frame: Assessing change from baseline to post-intervention (9-weeks).
Measured using the Physical Self-Description Questionnaire (PSDQ), which is a multidimensional tool used to measure physical self--perceptions, body image and self--concept. The purpose of the PSDQ is to see how people describe themselves physically.
2 secondary outcomes
Sport Enjoyment and Commitment
Time frame: Assessing change from baseline to post-intervention (9-weeks).
Participant satisfaction and acceptability of the GUM program
Time frame: Post-Intervention (9-weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Derived from this study: PubMed 32515748Caperchione CM, Hargreaves N, Sabiston CM, Berg S, Kowalski KC, Ferguson LJ. Exploring the Effectiveness of an Integrated Physical Activity and Psychosocial Program Targeting At-Risk Adolescent Girls: Protocol for the Girls United and on the Move (GUM) Intervention Study. JMIR Res Protoc. 2020 Jun 9;9(6):e15302. doi: 10.2196/15302.
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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. This study is not recruiting at the moment.
Cristina Caperchione, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Arm Feasibility in people with Physical Activity, run by University of British Columbia 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 2 inclusion and 1 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 4 Oct 2019. 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?
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?
Body Image (time frame: Assessing change from baseline to post-intervention (9-weeks).). The study lists 3 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 NCT03567200, which also lists 1 linked publication.
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 4 Oct 2019.