Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202604875951154 Date of Registration: 24/04/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nutrition education intervention with control group among hypertensive patients
Official scientific title Effectiveness of a Nutrition Education Intervention Based on Pender’s Health Promotion Model in Controlling Blood Pressure Level Among Hypertensive Patients: An Interventional Study with Control Group
Brief summary describing the background and objectives of the trial Hypertension is a major public health problem associated with increased risk of cardiovascular diseases. Lifestyle modification, particularly nutrition education, plays a crucial role in blood pressure control. This study aimed to evaluate the effectiveness of a nutrition education intervention based on Pender’s Health Promotion Model in improving blood pressure levels among hypertensive patients. A controlled interventional study (quasi-experimental pre–post design) was conducted, where participants were assigned to either an intervention group receiving structured nutrition education or a control group receiving standard care. The primary outcome included lifestyle behavior changes, while the secondary outcome was the change in blood pressure levels. The findings support the integration of theory-based educational interventions into hypertension management, where the nutrition educational intervention was associated with a significant decrease in systolic blood pressure and diastolic blood pressure among the intervention group as compared to the control group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 05/12/2021
Actual trial start date 05/12/2021
Anticipated date of last follow up 27/01/2023
Actual Last follow-up date 27/01/2023
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group structured nutrition education sessions A total of six educational sessions conducted through power point presentation A brochure was given to each person in the intervention group at the end of the intervention. Sessions conducted over two consecutive weeks (three days each week) and two sessions presented every day for each subgroup. Three subgroups met each day in the first week and two subgroups met each day in the second week. A total of six educational sessions conducted through power point presentation for the 50 participants of the intervention group [which was divided into 5 subgroups (10 participants/each subgroup)] using the following outlines: Healthy eating (30 minutes), social support (15 minutes), physical activity (30 minutes), self efficacy (15 minutes), adherence to medications (20 minutes), and goal setting (20 minutes). A brochure was given to each person in the intervention group at the end of the intervention. 50
Control Group No structured intervention Not applicable Preliminary assessment of each participant at the beginning of the study Reassessment at the end of the study (for both groups after three months of the educational intervention) The control group received the routine care and the same brochure was given to each person in the control group but at the end of the study. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients attending the internal medicine Health Insurance Clinic in Kafr El-Dawwar, Al-Beheira Governorate, Egypt Patients with essential hypertension Patients aged 40 years or more Patients who suffered from secondary hypertension Patients aged less than 40 years. 80 and over: 80+ Year,Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/05/2021 Ethics Committee of High Institute of Public Health
Ethics Committee Address
Street address City Postal code Country
165 El-Horreya Avenue Alexandria 21561 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/11/2021 Ethics Committee of Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
El-Khartoum Square Alexandria 21526 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/06/2022 Ethics Committee of Ministry of Health and Population
Ethics Committee Address
Street address City Postal code Country
Magles El Shaab Street Cairo 11511 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/11/2021 Ethics Committee of General Authority for Health Insurance
Ethics Committee Address
Street address City Postal code Country
Heliopolis Cairo 11341 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement in the studied healthy self‐care behaviors; healthy eating, physical activity, and adherence to medications three months after educational sessions. Three months after educational sessions.
Secondary Outcome Improvement in blood pressure level and weight measurements three months after educational sessions Three months after educational sessions.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Internal Medicine Health Insurance Clinic Ahmed Orabi Street, Kafr El- Dawwar Alexandria 22636 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Doaa Hamdy Elsakhawy Kafr El- Dawwar Alexandria 22621 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Doaa Hamdy Elsakhawy Kafr El- Dawwar Alexandria 22621 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Fikrat Ahmed Elsahn 134 Tariq Elhorreya, Elhadra Alexandria 21561 Egypt
Zeinab Nazeeh Aly Shata Smouha Alexandria 21614 Egypt
Doaa Tawfik Mohamed Smouha Alexandria 21614 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa Hamdy Elsakhawy hiph.delsakhawy@alexu.edu.eg 00201552564393 Kafr El- Dawwar
City Postal code Country Position/Affiliation
Alexandria 22621 Egypt Lecturer of Nutrition
Role Name Email Phone Street address
Public Enquiries Fikrat Ahmed Elsahn fikratelsahn@gmail.com 00201023486677 134 Tariq Alhorreya, Alhadra
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Nutrition
Role Name Email Phone Street address
Scientific Enquiries Zeinab Nazeeh Shata hiph.zshata@alexu.edu.eg 00201007978715 Smouha
City Postal code Country Position/Affiliation
Alexandria 21614 Egypt Professor of Mental Health
Role Name Email Phone Street address
Scientific Enquiries Doaa Tawfik Mohamed doaa_tawfik@alexu.edu.eg 00201226153630 Smouha
City Postal code Country Position/Affiliation
Alexandria 21614 Egypt Assistant Professor of Nutrition
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data will be available upon request. Participants provided verbal consent for participation and data use, which was approved by the relevant ethics committees because the study does not involve giving any investigational medicines or taking any biological samples. Analytic code is not available because all analyses were performed directly in SPSS. Access can be requested by contacting the principal investigator via the email listed in the trial registry Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be available upon request Data will be available to qualified researchers affiliated with recognized institutions. Researchers must submit a formal request outlining the research objectives. Access is subject to approval by the principal investigator, and a data use agreement must be signed prior to sharing to ensure confidentiality and appropriate use
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available Yes 02/04/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/04/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks The study protocol is registered in the Digital Library of Alexandria University. No public link is available; the protocol can be requested directly from the principal investigator via email
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 16/04/2026 These modifications have been made in accordance with your request This controlled interventional study (quasi-experimental pre–post design) aimed to evaluate the effectiveness of a structured nutrition education intervention based on Pender’s Health Promotion Model on improvement of hypertension self-care activity level effects (H-SCALE) and blood pressure control. Participants were allocated into an intervention group (n=50) receiving structured nutrition education sessions and a control group (n=50) receiving routine care without structured intervention. The study assessed changes in dietary practices and blood pressure three months after the intervention sessions. Hypertension is a major public health problem associated with increased risk of cardiovascular diseases. Lifestyle modification, particularly nutrition education, plays a crucial role in blood pressure control. This study aimed to evaluate the effectiveness of a nutrition education intervention based on Pender’s Health Promotion Model in improving blood pressure levels among hypertensive patients. A controlled interventional study (quasi-experimental pre–post design) was conducted, where participants were assigned to either an intervention group receiving structured nutrition education or a control group receiving standard care. The primary outcome included lifestyle behavior changes, while the secondary outcome was the change in blood pressure levels. The findings support the integration of theory-based educational interventions into hypertension management, where the nutrition educational intervention was associated with a significant decrease in systolic blood pressure and diastolic blood pressure among the intervention group as compared to the control group.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 16/04/2026 These modifications have been made in accordance with your request CCT RCT