Heart DiseasesNCT05949892
Heart-health Promotion
A study testing Expanded Health Belief Model-Based Intervention in people with Heart Diseases, run by University of Baghdad at 1 site in Iraq.
Trial summary
The researchers intend to use the Expanded Health Belief Model in enhancing heart-health preventive behaviors among high school female students Read more about this study
- Who is it for?
- Ages 15 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Expanded Health Belief Model-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIraq
- Study dates
- 12 Sep 2023to 24 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school female students who do not experience any psychiatric-mental disorder
Who cannot join
- High school female students who experience any psychiatric-mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
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
The researchers intend to use the Expanded Health Belief Model in enhancing heart-health preventive behaviors among high school female students
Read the 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.
- Conditions
- Heart Diseases
- Being tested
- Expanded Health Belief Model-Based Intervention
- Keywords
- Expanded Health Belief Model, Heart-Health-Preventive Behaviors, High School Female Students
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Health Belief Model-Based InterventionBehavioural
A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Behavioral: Expanded Health Belief Model-Based Intervention |
| Stress management | Experimental | This arm will focus on the following:
Stress relief Relaxation techniques Meditation Mindfulness exercises Receives: 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 Receives: Behavioral: Expanded Health Belief Model-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Intention Scale for Adherence to Heart-Health Preventive Behaviors
Enhancing Heart-Health Preventive Behaviors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start12 Sep 2023
- Primary completion24 Mar 2024
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Baqer Habeeb Abd Ali, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949892
- Sponsor's protocol ID
- Heart-Health Promotion
- Status last verified
- Mar 2024
- First submitted
- 1 Jul 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05949892
- Acronym / sponsor ID
- Heart-Health Promotion
- Conditions
- Heart Diseases
- Keywords
- Expanded Health Belief Model, Heart-Health-Preventive Behaviors, High School Female Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 24 Mar 2024 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A healthy diet | Experimental | Behavioral: Expanded Health Belief Model-Based InterventionThis 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 |
| Healthy Weight Management | Experimental | Behavioral: Expanded Health Belief Model-Based InterventionThis 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 |
| Physical Activity | Experimental | Behavioral: Expanded Health Belief Model-Based InterventionThis 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 |
| Stress management | Experimental | Behavioral: Expanded Health Belief Model-Based InterventionThis arm will focus on the following: Stress relief Relaxation techniques Meditation Mindfulness exercises |
| Smoking Cessation and Avoidance | Experimental | Behavioral: Expanded Health Belief Model-Based InterventionThis arm will focus on the following: Second-hand smoke Offering option to avoid secondhand smoke |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- High school female students who do not experience any psychiatric-mental disorder
Key exclusion criteria (1 listed)
- High school female students who experience any psychiatric-mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded Health Belief Model-Based InterventionA healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance | Behavioural | A healthy diet, Healthy Weight Management, Physical Activity, Smoking Cessation and Avoidance, Stress management |
Primary outcome
Behavioral Intention Scale for Adherence to Heart-Health Preventive Behaviors
Time frame: 6 months
Enhancing Heart-Health Preventive Behaviors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Health Belief Model-Based Intervention in people with Heart Diseases, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Intention Scale for Adherence to Heart-Health Preventive Behaviors (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.