NCT06873126

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

January 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 6, 2025

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Study Arms (2)

Mental health

ACTIVE COMPARATOR

To compare the relationship between mental health and adherence to physical activity

Combination Product: Counselling sessions

Physical activity

ACTIVE COMPARATOR

To compare the relationship between mental health and adherence to physical activity

Combination Product: Counselling sessions

Interventions

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.

Mental healthPhysical activity

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jazan University

Jizan, Jazan Region, Saudi Arabia

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 12, 2025

Study Start

January 1, 2025

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations