NCT05949892

Brief Summary

The researchers intend to use the Expanded Health Belief Model in enhancing heart-health preventive behaviors 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2023

Completed
17 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

July 1, 2023

Last Update Submit

March 23, 2024

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

    Enhancing Heart-Health Preventive Behaviors

    6 months

Study Arms (5)

A healthy diet

EXPERIMENTAL

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

Healthy Weight Management

EXPERIMENTAL

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

Physical Activity

EXPERIMENTAL

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

Stress management

EXPERIMENTAL

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

Behavioral: Expanded Health Belief Model-Based Intervention

Smoking Cessation and Avoidance

EXPERIMENTAL

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

Behavioral: Expanded Health Belief Model-Based Intervention

Interventions

A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance

A healthy dietHealthy Weight ManagementPhysical ActivitySmoking Cessation and AvoidanceStress management

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 psychiatric-mental disorder

You may not qualify if:

  • High school female 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

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Students in the control group will be masked from any form of the proposed intervention arms.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 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