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.: PACTR202011772340456 Date of Approval: 29/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF NUTRITIONAL EDUCATION ON BLOOD PRESSURE CONTROL OF HYPERTENSIVE PATIENTS WHO ATTEND THEIR FOLLOW UP UNITS AT HAWASSA CITY HOSPITALS, HAWASSA, SIDAMA REGION, SOUTHERN ETHIOPIA
Official scientific title EFFECT OF NUTRITIONAL EDUCATION ON BLOOD PRESSURE CONTROL OF HYPERTENSIVE PATIENTS WHO ATTEND THEIR FOLLOW UP UNITS AT HAWASSA CITY HOSPITALS, HAWASSA, SIDAMA REGION, SOUTHERN ETHIOPIA
Brief summary describing the background and objectives of the trial Background and objective of the trial Nutrition especially DASH diet is one of the influential non- pharmacological approach which emphasizes fruits, vegetables, and low-fat dairy and is low in meats, sugar-sweetened beverages, and saturated and total fat used to lower BP. DASH diet was linked with ever increasing adherence of hypertensive to recommended DASH diet and increasing DASH adherence have role in improving the body mass index (BMI) and blood pressure level. As a result there is no study on the effect of nutrition education on blood pressure control among hypertensive patients in Ethiopia especially in the study area. Therefore adults age are at risk group which needs behavioral change education as they are more susceptible for the development of hypertension and need to educate them in order to help them gain awareness about healthy nutrition Objective: The main objective of this study is to assess the effect of nutrition education on blood pressure control among hypertensive patients who have follow up at Hawassa hospitals, Hawassa city, Sidama region, Southern Ethiopia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/10/2019
Actual trial start date 23/10/2019
Anticipated date of last follow up 04/02/2020
Actual Last follow-up date 15/02/2020
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition education 4 sessions They will be followed for 3 months to compare them with the intervention group at the end of intervention Arm1;-Hypertensive patients will attend DASH diet nutrition education lesson per two weeks continuously for 3 months. 160
Control Group No nutrition education for control group They will be followed for 3 months to compare them with the intervention group at the end of intervention The control group will receive nothing. 160 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hypertensive patients’ age between 20-65 years receiving medical treatment having a health record in the study hospitals who permanently reside in Hawassa town during the study period will include in the study. Hypertensive patients suffering from acute or chronic complications at the time of diagnosis of hypertension who participate in any other hypertension/nutrition education program recently Patients with any physical or mental disability that hinder the intervention e.g., blindness or deafness will exclude from the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 17/09/2019 Hawassa University institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Bus station to referral hospital Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Controlled blood pressure At base line and end line
Secondary Outcome DASH diet adherence At base line and end line
Secondary Outcome BMI At base line and end line
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
College of Agriculture Hawassa Street down to Piazza Hawassa 0005 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Ethiopian ministry of education To Holly trinity cathedral road Addis Ababa 1000 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wollega university To DIPPO oil station road Nekemte 1519 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Hawassa university Menaheria to Hawassa University Main Campus Hawassa 0005 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dinkayow Degafe dinkayowdegafe2@gmail.com +251946269841 Bus station to bekenisa kese
City Postal code Country Position/Affiliation
Nekemte 1519 Ethiopia Assistant lecturer at Wollega university
Role Name Email Phone Street address
Public Enquiries Gudina Egata fenetg@gmail.com +251911641362 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Associate professor of Public Health and Child Health School of Public Health College of Health and Medical Sciences
Role Name Email Phone Street address
Scientific Enquiries Alemzewed Challa alemzewed.challa2011@gmail.com +251916823122 Hawassa
City Postal code Country Position/Affiliation
Hawassa 560 Ethiopia PHD candidate at Hawassa university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All Individual Participant Data will be shared in EpiData/EpiInfo/Spreed Sheet format immediately following the publication. The data will available to anyone interested. Additionally data analysis plan will be shared. Informed Consent Form,Statistical Analysis Plan The IPD package will be shared after publication, after March 2020. It will be as per the rules and regulations of the PACTR and journals to publish the scientific papers.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information