Heart-health Promotion

Sponsor

University of Baghdad (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05949892

Collaborator

Afnan Hadi Khudhayer (Other)

144

Enrollment

Arms

7.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The researchers intend to use the Expanded Health Belief Model in enhancing heart-health preventive behaviors among high school female students

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases	Behavioral: Expanded Health Belief Model-Based Intervention	N/A

Detailed Description

The study intervention will be derived from the Expanded Health Belief Model which includes adhering to healthy diet, encouraging healthy weight, nutrition, and physical activity stress management, and smoking cessation and smoking avoidance.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Masking Description:

Students in the control group will be masked from any form of the proposed intervention arms.

Primary Purpose:

Prevention

Official Title:

Efficacy of The Expanded Health Belief Model-Based Intervention in Enhancing Heart-Health Preventive Behaviors Among High School Female Students: A Randomized Controlled Trial

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

May 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A healthy diet This arm will focus on the following: Eating lots of vegetables and fruit Choosing whole grain foods Eating protein foods Limiting highly and ultra-processed foods Highly processed foods Making water your drink of choice Salt, sodium and potassium Refraining from added sugars	Behavioral: Expanded Health Belief Model-Based Intervention A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance
Experimental: Healthy Weight Management This arm will focus on the following: Physical Activity for a Healthy Weight Preventing Weight Gain Choosing an Eating Plan to Prevent Weight Gain Balancing Food and Activity for Healthy Weight	Behavioral: Expanded Health Belief Model-Based Intervention A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance
Experimental: Physical Activity This arm will focus on the following: Step 1: Make a commitment Step 2: Take stock of where you are Step 3: Set realistic goals Step 4: Identify resources for information and support Step 5: Continually "check in" with yourself to monitor your progress. Revisit the goals you set for yourself in Step 3 and evaluate your progress regularly	Behavioral: Expanded Health Belief Model-Based Intervention A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance
Experimental: Stress management This arm will focus on the following: Stress relief Relaxation techniques Meditation Mindfulness exercises	Behavioral: Expanded Health Belief Model-Based Intervention A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance
Experimental: Smoking Cessation and Avoidance This arm will focus on the following: Second-hand smoke Offering option to avoid secondhand smoke	Behavioral: Expanded Health Belief Model-Based Intervention A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance

Outcome Measures

Primary Outcome Measures

Behavioral Intention Scale for Adherence to Heart-Health Preventive Behaviors [6 months]
Enhancing Heart-Health Preventive Behaviors

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 female students who do not experience any psychiatric-mental disorder

Exclusion Criteria:

High school female students who experience any psychiatric-mental disorder

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Baghdad
Afnan Hadi Khudhayer

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:

NCT05949892

Other Study ID Numbers:

Heart-Health Promotion

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:

Keywords provided by Mohammed Baqer Habeeb Abd Ali, Principal Investigator, University of Baghdad

Expanded Health Belief Model, Heart-Health-Preventive Behaviors, High School Female Students

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of Jul 18, 2023