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Heart-health Promotion

Primary Purpose

Heart Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expanded Health Belief Model-Based Intervention
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Diseases focused on measuring Expanded Health Belief Model, Heart-Health-Preventive Behaviors, High School Female Students

Eligibility Criteria

15 Years - 20 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    A healthy diet

    Healthy Weight Management

    Physical Activity

    Stress management

    Smoking Cessation and Avoidance

    Arm Description

    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

    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

    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

    This arm will focus on the following: Stress relief Relaxation techniques Meditation Mindfulness exercises

    This arm will focus on the following: Second-hand smoke Offering option to avoid secondhand smoke

    Outcomes

    Primary Outcome Measures

    Behavioral Intention Scale for Adherence to Heart-Health Preventive Behaviors
    Enhancing Heart-Health Preventive Behaviors

    Secondary Outcome Measures

    Full Information

    First Posted
    July 1, 2023
    Last Updated
    July 9, 2023
    Sponsor
    University of Baghdad
    Collaborators
    Afnan Hadi Khudhayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05949892
    Brief Title
    Heart-health Promotion
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    May 10, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Baghdad
    Collaborators
    Afnan Hadi Khudhayer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Diseases
    Keywords
    Expanded Health Belief Model, Heart-Health-Preventive Behaviors, High School Female Students

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    Participant
    Masking Description
    Students in the control group will be masked from any form of the proposed intervention arms.
    Allocation
    Randomized
    Enrollment
    144 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A healthy diet
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Healthy Weight Management
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Physical Activity
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Stress management
    Arm Type
    Experimental
    Arm Description
    This arm will focus on the following: Stress relief Relaxation techniques Meditation Mindfulness exercises
    Arm Title
    Smoking Cessation and Avoidance
    Arm Type
    Experimental
    Arm Description
    This arm will focus on the following: Second-hand smoke Offering option to avoid secondhand smoke
    Intervention Type
    Behavioral
    Intervention Name(s)
    Expanded Health Belief Model-Based Intervention
    Intervention Description
    A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance
    Primary Outcome Measure Information:
    Title
    Behavioral Intention Scale for Adherence to Heart-Health Preventive Behaviors
    Description
    Enhancing Heart-Health Preventive Behaviors
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    High school female students
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Heart-health Promotion

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