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.: PACTR202011572283256 Date of Approval: 30/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lifestyle educational intervention to reduce the risk of developing cardiovascular diseases among vulnerable population in Dodoma City
Official scientific title Effectiveness of community based lifestyle educational intervention to reduce the risk of developing cardiovascular diseases among vulnerable population in Dodoma City
Brief summary describing the background and objectives of the trial Cardiovascular Diseases (CVDs) is a general term for conditions affecting the heart and blood vessels (American Heart Association, 1996). There are many different types of CVDs. The four common types are; coronary heart disease, stroke, peripheral arterial diseases and aortic diseases (American Heart Association, 1996). The exact cause of cardiovascular diseases (CVDs) is not clear, but there are many risk factors which have been identified to cause the diseases. These factors can be categorized into modifiable and non-modifiable risk factors. The modifiable risk factors can be divided into biological and behavioral risk factors. Biological risk factors includes; elevated blood pressure, dyslipidemia, elevated blood sugar, overweight and obesity. Behavioral risk factors includes; smoking, excessive alcohol intakes, unhealthy diet and physical inactivity (WHO, 2005). The non-modifiable risk factors include; family history of CVDs, age and gender (American Heart Association, 1996). For the focus of this study biological CVDs risk factors will be considered as elevated blood pressure, elevated blood sugar, overweight and obesity. Cardiovascular diseases are the leading cause of death and disability globally, and is projected to accounting for more than 24 million deaths by 2030 (Fuster et al., 2011). About 80% of the deaths is expected to occur in low and middle-income countries (WHO, 2019). Sub-Saharan Africa (SSA) is experiencing an epidemic of cardiovascular diseases (CVDs) on unimaginable scale whereby disability and mortality attributable to CVDs and the traditional risk factors, including hypertension, obesity, diabetes mellitus, and dyslipidemia, continue to rise in several countries (Kofi, 2018). The increasing burden of CVDs is driven mainly by four modifiable risk factors, namely unhealthy dietary habits characterized by consumption of high energy-dense foods, physical inactivity, excessive alcohol drinking and smoking (Reddy, 2015). Tanzania like other deve
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 Early detection /Screening
Anticipated trial start date 03/12/2020
Actual trial start date 04/01/2021
Anticipated date of last follow up 03/06/2021
Actual Last follow-up date 31/08/2021
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants) 720
Recruitment status Not yet 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community based healthy lifestyle education promotion interventions Health education and healthy lifestyle promotion will be given to each individual twice per month for the first three months (Month 1 to Month 3), then it will be given once once per month for second three months (Month 4 to Month 6) Measurements of blood pressure, blood glucose, body height, body weight and waist circumference of each individual will be taken twice per month for the first three months (Month 1 to Month 3), then it will be given once once per month for second three months (Month 4 to Month 6) Six months Researchers and research assistants will conduct health education to participant during household visit to raise awareness about CVDs risk factors and promote healthy lifestyles. The health education will focus on information pertaining to the harmful effects of CVDs risk factors; maintaining healthy body weight, smoking cessation, reduction of excessive alcohol drinking, reduction of salt intake, reducing fat intakes, increased consumption of fruits and green leafy vegetables and use of unrefined cereals. Participants will also be provided with the brochures on CVDs risk factors for their reference. Brochures will consist of illustrative information which will be easy to follow incase participant is not able to read. Health education and healthy lifestyle promotion will be given twice in the first three months and then monthly for the second three months. In line with the lifestyle promotion measurements of blood pressure, blood glucose, body height, body weight and waist circumference of each individual will be taken twice per month for the first three months (Month 1 to Month 3), then it will be given once once per month for second three months (Month 4 to Month 6) 400
Control Group Community based healthy lifestyle education promotion Measurements of blood pressure, blood glucose, body height, body weight and waist circumference of each individual will be taken twice per month for the first three months (Month 1 to Month 3) and then once per month for the second three months (Month 4 to Month 6) six months The control group will be measured blood pressure, blood glucose, body height, body weight and waist circumference only. For ethical consideration, the control group will receive healthy lifestyle education promotion at the end of the study 400 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adults aged 31 years and above, who agreed and signed the consent and expect to live in study area until the end of the study. Pregnant women, known cases of hypertension known cases of diabetes severely ill patients mentally ill individuals. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 31 Year(s) 65 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 08/07/2020 University of Dodoma Institutional Research Review Committee
Ethics Committee Address
Street address City Postal code Country
Iyumbu Dodoma 255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is change in the proportion of overweight/obesity at six months in the intervention group compared to control group. The study aims to detect a proportional change in body BMI of ≥20 percentage in the intervention group compared to control group. After six months
Secondary Outcome (1) change from baseline in the proportion of individuals at high risk for CVDs (elevated blood glucose, elevated blood pressure) for ≥20%; (2) change from baseline in the proportion of smoking, alcohol intake, unhealthy dietary habits, and physical inactivity. After six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dodoma Region Iyumbu Dodoma United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The University of Dodoma Iyumbu Dodoma United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The University of Dodoma Iyumbu Dodoma United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nyasiro Gibore nyasiro@hotmail.com +255713465878 Iyumbu
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Lecturer
Role Name Email Phone Street address
Public Enquiries Ainory Gesase agasase@yahoo.com +255784604533 Iyumbu
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania professor
Role Name Email Phone Street address
Scientific Enquiries Mariam Munyogwa munyogwam@yahoo.com +255768049487 Iyumbu
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Lecturer
Role Name Email Phone Street address
Scientific Enquiries Secilia Kapalata mwatty92@yahoo.com +255754690877 Iyumbu
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Lecture
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that will be generated from this study will be shared upon request from the researchers and permission from the University of Dodoma research and publication Director Informed Consent Form,Statistical Analysis Plan,Study Protocol One year after completion of the study upon request from the principal investigator
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