Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction

Sponsor

University of Baghdad (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05949918

Collaborator

Eman Hammad Hafith (Other)

144

Enrollment

Arms

7.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary Fat Reduction	Behavioral: Stage-matched interventions	N/A

Detailed Description

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction Among Female High School Students: A Randomized Controlled Trial

Anticipated Study Start Date :

Sep 12, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

May 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Precontemplation, Contemplation, Preparation, Action, and Maintenance-based intervention 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 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.
Experimental: Contemplation-based intervention 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 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.
Experimental: Preparation-based intervention 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 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.
Experimental: Action-based intervention 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 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.
Experimental: Maintenance-based intervention 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 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.

Outcome Measures

Primary Outcome Measures

Stages of Change Scale for Dietary Fat Reduction [6 months]
Stages of Change Scale for Dietary Fat Reduction measures individuals' readiness to reduce dietary fat.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 20 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Baghdad
Eman Hammad Hafith

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Baqer Habeeb Abd Ali, Principal Investigator, University of Baghdad

ClinicalTrials.gov Identifier:

NCT05949918

Other Study ID Numbers:

Dietary Fat Reduction

First Posted:

Jul 18, 2023

Last Update Posted:

Jul 18, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 18, 2023