Mental HealthPhase 3NCT06873126
Two Group Experimental Trial Promoting Sports and Exercise Among Female University Students in Saudi Arabia
A Phase 3 study testing Counselling sessions in people with Mental Health, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
The study provides insights into the use of awareness counselling sessions for physical activity promotion, which may have a significant impact on physical activity education, promotion, practice and policy making and will be more effective to ensure adherence to activity among young adults. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Counselling sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2025to Apr 2025
- Phase
- Phase 3
- 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
- Participants scoring between 0 to 10 (normal) and 11 to 16 (mild) and 16 to 20 (moderate) in DASS-21 depression subscale
- voluntary participants
- physical activity level lightly active
Who cannot join
- University students diagnosed with psychiatric disorders and taking therapy or family history of mental illness
- Students with comorbid conditions such as chronic pain, respiratory disorders, musculoskeletal diseases, cardiac diseases, neurological diseases or any disabilities and pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-group Experimental Trial to Promote Sports and Exercise Among Female University Students in Saudi Arabia: the Relationship Between Mental Health and Adherence to Phyicsal Activity
The study provides insights into the use of awareness counselling sessions for physical activity promotion, which may have a significant impact on physical activity education, promotion, practice and policy making and will be more effective to ensure adherence to activity among young adults.
- Conditions
- Mental Health
- Being tested
- Counselling sessions
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling sessionsCombination product
The study provides insights into the use of awareness counselling sessions for physical activity promotion, which may have a significant impact on physical activity education, promotion, practice and policy making and will be more effective to ensure adherence to activity among young adults.
| Study group | Role | What they receive |
|---|---|---|
| Mental health | Active comparator | To compare the relationship between mental health and adherence to physical activity Receives: Combination Product: Counselling sessions |
| Physical activity | Active comparator | To compare the relationship between mental health and adherence to physical activity Receives: Combination Product: Counselling sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily moderate- to vigorous-intensity physical activity (MVPA), physical activity level (PAL) evaluated using IPAQ-SF
International Physical Activity Questionnaire Short Form (IPAQ-SF) was used to measure the physical activity among students. The IPAQ measures the type and intensity of physical activity and time spent walking and sitting in a duration of 7 days. A higher IPAQ score indicates a higher intensity of physical activity.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Jan 2025
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vandana Esht, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873126
- Sponsor's protocol ID
- REC-46/06/1229
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-group Experimental Trial to Promote Sports and Exercise Among Female University Students in Saudi Arabia: the Relationship Between Mental Health and Adherence to Phyicsal Activity
- ClinicalTrials.gov ID
- NCT06873126
- Acronym / sponsor ID
- REC-46/06/1229
- Conditions
- Mental Health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Mar 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 study provides insights into the use of awareness counselling sessions for physical activity promotion, which may have a significant impact on physical activity education, promotion, practice and policy making and will be more effective to ensure adherence to activity among young adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental health | Active comparator | Combination Product: Counselling sessionsTo compare the relationship between mental health and adherence to physical activity |
| Physical activity | Active comparator | Combination Product: Counselling sessionsTo compare the relationship between mental health and adherence to physical activity |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants scoring between 0 to 10 (normal) and 11 to 16 (mild) and 16 to 20 (moderate) in DASS-21 depression subscale
- voluntary participants
- physical activity level lightly active
Key exclusion criteria (2 listed)
- University students diagnosed with psychiatric disorders and taking therapy or family history of mental illness
- Students with comorbid conditions such as chronic pain, respiratory disorders, musculoskeletal diseases, cardiac diseases, neurological diseases or any disabilities and pregnancy
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 |
|---|---|---|
| Counselling sessionsThe study provides insights into the use of awareness counselling sessions for physical activity promotion, which may have a significant impact on physical activity education, promotion, practice and policy making and will be more effective to ensure adherence to activity among young adults. | Combination product | Mental health, Physical activity |
Primary outcome
daily moderate- to vigorous-intensity physical activity (MVPA), physical activity level (PAL) evaluated using IPAQ-SF
Time frame: 7 days
International Physical Activity Questionnaire Short Form (IPAQ-SF) was used to measure the physical activity among students. The IPAQ measures the type and intensity of physical activity and time spent walking and sitting in a duration of 7 days. A higher IPAQ score indicates a higher intensity of physical activity.
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 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Counselling sessions in people with Mental Health, run by University of Jazan at 1 site in Saudi Arabia.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 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 Saudi Arabia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
daily moderate- to vigorous-intensity physical activity (MVPA), physical activity level (PAL) evaluated using IPAQ-SF (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2025.