NCT05938634

Brief Summary

A randomized controlled trial that uses a Stage-matched intervention based on the Transtheoretical Model of Change to enhance engaging in regular physical exercise among high school female students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

June 28, 2023

Last Update Submit

March 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Engaging in regular physical exercise

    6 months

Study Arms (5)

Precontemplation

EXPERIMENTAL

The intervention that would involve the Processes of Change that people use when they would be in the Precontemplation Stage of Change.

Behavioral: Stage-matched interventions

Contemplation-based intervention

EXPERIMENTAL

The intervention that would involve the Processes of Change that people use when they would be in the Contemplation Stage of Change.

Behavioral: Stage-matched interventions

Preparation-based intervention

EXPERIMENTAL

The intervention that would involve the Processes of Change that people use when they would be in the Preparation Stage of Change.

Behavioral: Stage-matched interventions

Action-based intervention

EXPERIMENTAL

The intervention that would involve the Processes of Change that people use when they would be in the Action Stage of Change.

Behavioral: Stage-matched interventions

Maintenance-based intervention

EXPERIMENTAL

The intervention that would involve the Processes of Change that people use when they would be in the Maintenance Stage of Change.

Behavioral: Stage-matched interventions

Interventions

Precontemplation-based intervention Contemplation-based intervention Preparation-based intervention Action-based intervention Maintenance-based intervention

Action-based interventionContemplation-based interventionMaintenance-based interventionPrecontemplationPreparation-based intervention

Eligibility Criteria

Age15 Years - 20 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHigh school female students
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school female students who do not experience any physical disability.

You may not qualify if:

  • High school female students who experience any physical disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Baghdad

Baghdad, 14149, Iraq

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in the control group will be masked from the proposed intervention. Participants in the study group (in each Stage of Change) will be masked from the type of intervention they are supposed to receive.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty member

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 10, 2023

Study Start

September 12, 2023

Primary Completion

March 21, 2024

Study Completion

March 21, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations