NCT05949918

Brief Summary

This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 18, 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 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 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

Dietary Fat Reduction

Outcome Measures

Primary Outcomes (1)

  • Stages of Change Scale for Dietary Fat Reduction

    Stages of Change Scale for Dietary Fat Reduction measures individuals' readiness to reduce dietary fat.

    6 months

Study Arms (5)

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

EXPERIMENTAL

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

Behavioral: Stage-matched interventions

Interventions

Stage-matched interventionsBEHAVIORAL

The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in. A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.

Action-based interventionContemplation-based interventionMaintenance-based interventionPrecontemplation, Contemplation, Preparation, Action, and Maintenance-based interventionPreparation-based intervention

Eligibility Criteria

Age15 Years - 20 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHigh school male students who do not experience any psychiatric-mental disorder.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school male students who do not experience any psychiatric-mental disorder.

You may not qualify if:

  • High school male students who experience any psychiatric-mental disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Baghdad

Baghdad, 14149, Iraq

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The researchers will use two groups (study and control) in which participants will be randomly selected and assigned in each of the study and control groups using simple random sampling. The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 18, 2023

Study Start

September 12, 2023

Primary Completion

March 24, 2024

Study Completion

March 24, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

IR(1)