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.: PACTR202009693949631 Date of Registration: 02/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Examining the effect of education on dietary calcium intake in reducing Blood pressure variability
Official scientific title Examining the effect of education on dietary calcium intake in reducing Blood pressure variability among pregnant mothers in Tigray Region, Northern Ethiopia, two-arm, randomized control trial parallel design
Brief summary describing the background and objectives of the trial Investigating the effects of calcium diets on blood pressure can contribute to the development of diet based recommendations for health. Epidemiologic data suggest contradicting evidence relationship between dietary calcium intake and pregnancy-induced hypertension. So, this study aimed to determine the effect of calcium nutrition education on blood pressure variability among pregnant mothers.
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,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 28/05/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 02/09/2019
Actual Last follow-up date 30/09/2019
Anticipated target sample size (number of participants) 526
Actual target sample size (number of participants) 415
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 was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control arm monthly 3 months Dietary intake was assessed at baseline and in every weekly visit to household using an interactive 24-hour recall method. After completing the baseline assessments (described further in study assessments) mothers were randomly assigned to either the education on dietary intake of calcium containing foods or the control group. The randomization was 1:1 for the 2 groups and was performed using simple randomization computer generated codes for each individual. For pregnant mothers in the calcium nutritional education intake group, a target calcium intake was calculated on the basis of 1200 milligram per day baseline, and the importance of meeting this target intake was explained to mothers. An estimate of current dietary intake was made from an interactive 24-h food recall; education was provided about the intake in relation to the target intake, and mothers were given a dietary plan to meet the target intake. Pregnant mothers were instructed to consume these foods per serving required to meet the target. Pregnant mothers were contacted house to house 3 times per week to assess progress and to provide the necessary feedback. Blood pressure was measured every month until the end of the intervention period. For pregnant mothers randomly assigned to the control group, general advice was given to address any major dietary imbalance identified from the interactive 24-h food recall at baseline. They were instructed to increase their food intake as they felt able but were not given a specific plan for dietary intake. Measurement of Blood Pressure Blood pressure was measured once per week per subject using an aneroid sphygmomanometer (Marshall Electronics, Inc., Clayton Division, Skokie, Ill.). Readings was recorded three times with 1 min between each reading. Participants was allowed a 10-min rest period before readings taken. All participants maintained a sitting position while blood pressure was measured in the non-dominant arm. A measurement was made at the same time of 263 Dose Comparison
Experimental Group intervention group or counseling group weekly and monthly 3 month Dietary intake was assessed at baseline and in every weekly visit to household using an interactive 24-hour recall method. After completing the baseline assessments (described further in study assessments) mothers were randomly assigned to either the education on dietary intake of calcium containing foods or the control group. The randomization was 1:1 for the 2 groups and was performed using simple randomization computer generated codes for each individual. For pregnant mothers in the calcium nutritional education intake group, a target calcium intake was calculated on the basis of 1200 milligram per day baseline, and the importance of meeting this target intake was explained to mothers. An estimate of current dietary intake was made from an interactive 24-h food recall; education was provided about the intake in relation to the target intake, and mothers were given a dietary plan to meet the target intake. Pregnant mothers were instructed to consume these foods per serving required to meet the target. Pregnant mothers were contacted house to house 3 times per week to assess progress and to provide the necessary feedback. Blood pressure was measured every month until the end of the intervention period. For pregnant mothers randomly assigned to the control group, general advice was given to address any major dietary imbalance identified from the interactive 24-h food recall at baseline. They were instructed to increase their food intake as they felt able but were not given a specific plan for dietary intake. Measurement of Blood Pressure Blood pressure was measured once per week per subject using an aneroid sphygmomanometer (Marshall Electronics, Inc., Clayton Division, Skokie, Ill.). Readings was recorded three times with 1 min between each reading. Participants was allowed a 10-min rest period before readings taken. All participants maintained a sitting position while blood pressure was measured in the non-dominant arm. A measurement was made at the same time of 263
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study participants will be pregnant women who had a mean systolic BP from 120 to 159 mmHg and a diastolic BP from 80 to 95 mmHg, based on six readings at two screening visits. Mothers with a systolic BP ≥160 mmHg or a diastolic BP ≥95 mmHg or that were taking antihypertensive medications will be excluded. In addition, persons with a self-reported history of clinical cardiovascular disease (CVD), cancer, chronic kidney disease, body mass index (BMI) ≥30 kg/m2. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 Year(s) Female
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 03/04/2019 Tigray Health Research Institute IRB
Ethics Committee Address
Street address City Postal code Country
Adi shumdhun Mekelle 1547 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome BP variability between the study groups monthly
Secondary Outcome Incidence of pregnancy induced hypertension during monthly and end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mekelle Adishumdhun mekelle 1547 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Tigray Health Research Institute Adi shumdhun Mekelle 1547 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tigray Health Research Institute Adi shumdhun Mekelle 1547 Ethiopia Tigray Health Research Institute
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mulugeta Woldu mulugetawoldu425@gmail.com +251945084848 ethio-china
City Postal code Country Position/Affiliation
Mekelle 1547 Ethiopia Researcher
Role Name Email Phone Street address
Public Enquiries Alemnesh Abrha alemneshab2017@gmail.com +2519759940 quiha
City Postal code Country Position/Affiliation
Mekelle 1547 Ethiopia Researcher
Role Name Email Phone Street address
Scientific Enquiries Brhane Ayele brhane3127@gmail.com +251910533127 Ayder
City Postal code Country Position/Affiliation
Mekelle Ethiopia Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data of individual participants Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol with in 6 month open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 02/09/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/09/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information