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.: PACTR202208642850935 Date of Registration: 04/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effectiveness of interventions to reduce cardio-metabolic risk factors among regular street food consumers in Dar es Salaam, Tanzania: A cluster randomized control trial
Official scientific title The effectiveness of interventions to reduce cardio-metabolic risk factors among regular street food consumers in Dar es Salaam, Tanzania: A cluster randomized control trial
Brief summary describing the background and objectives of the trial The world is experiencing unprecedented increase of type2 diabetes attributed to unhealthy diet due to low income to afford nutritious food, and low knowledge on nutritional values of food. Other drivers of the type2 diabetes include physical inactivity, harmful alcohol drinking, high blood pressure and high blood glucose, overweight/obese, unbalanced cholesterol, aging and family history of the disease. The significant number of people in urban areas relies on food supplied by Urban Street Food Vendors who rarely take into account nutritional value of food thus, putting urban dwellers at risk of getting type2 diabetes. The situation is also compromised by the fact that the available food quality control and enforcement mechanisms focus on monitoring risk factors linked to infectious diseases only. Despite substantial evidence on the burden of the type2 diabetes mellitus; little has been invested on possible prevention interventions to alleviate the problem which is currently imposing exorbitant costs to the country health systems and families. This randomized clinical trial aims to implement and evaluate the effectiveness of type2 diabetes metabolic risk factors reduction intervention package (health education and plate model) and to develop a model for predicting metabolic risk factors among urban street cooked food consumers in Dar es Salaam, Tanzania.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NPH TRIAL
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2019
Actual trial start date 01/04/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 31/05/2019
Anticipated target sample size (number of participants) 560
Actual target sample size (number of participants) 336
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2794 National Medical Research and Coordinating Committee
2291 Kilimanjaro Christian Medical University College Review Board
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 from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IP1 Participants received Type2 diabetes health education at least three times per week via text messages, group meetings, brochures and Burners. 3 months Health education package (IP1): Health education package will comprise of type2 diabetes information on risk factors, prevention strategies including plate model, sign and symptoms of the disease and complications of the disease. Participants will receive group education twice at their working places and health education text messages via their mobiles or relatives' phones will be given on weekly basis as well as brochures at least twice in the entire period of the study. 280
Control Group IP2 A Subsidized Food plate with carbohydrate (1/4 of the plate), protein (1/4 of the plate), fruits and vegetables (1/2 of the plate), per person/meal and Type2 Diabetes healthy education was given to study participants from Monday to Saturday each week. IP2 also included IP1 Type2 Diabetes healthy education, participants received health education at least three times per week via text messages, group meetings, brochures and Burners. 3 months Health education and healthy plate model (IP2): The plate model/healthy plate will comprise of a standard potions of carbohydrate (quarter), protein (quarter), fruits/vegetables (half) or 400 gram per day as well healthy drinks like water or milk. The package of health education will comprise of type2 diabetes information on risk factors, prevention strategies including plate model, sign and symptoms of the disease and complications of the disease. An intervention group in three sites with a total of 280 participants will receive both health education and plate model. Participants will be required to consume at least three healthy plates per week. They will also received group education and brochures twice in the entire period of the project. Health education text messages via their mobiles or relatives' phones will be given on weekly basis. 280 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i) aged 25–64 years; ii) consume at least three lunches per week at the same street food vendor; iii) have no plans to move out of the study area in the next 12 months; and iv) have been consuming street food for not less than one year; and v) are willing to participate in the study Pregnant or lactating women Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 64 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 05/06/2018 National Medical Research and Coordinating Committee
Ethics Committee Address
Street address City Postal code Country
2448 Luthuli/Sokoine Ocean Road Junction of Luthuli / Sokoine Drive Dar es Salaam National Institute for Medical Research P.O. Box 9653 Dar es Salaam, Tanzania Dar es Salaam 255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardio metabolic risk factors namely body mass index, blood glucose, triglycerides, and waist circumference, systolic and diastolic BP 3 months
Secondary Outcome Correct knowledge on T2DM and positive attitude scores towards prevention measures of T2DM were the secondary outcomes of interest 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Institute for Medical Research 2448 Luthuli/Sokoine Ocean Road Junction of Luthuli / Sokoine Drive Dar es Salaam National Institute for Medical Research P.O. Box 9653 Dar es Salaam, Tanzania Dar es Salaam 255 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Afrique One ASPIRE 01 BP 1303 Abidjan 01 Abidjan 225 Cote Divoire
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Afrique One ASPIRE 01 BP 1303 Abidjan 01 Abidjan 225 Cote Divoire Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gibson Kagaruki gkagaruki@gmail.com +255757404142 P.O. Box 9653 Dar es Salaam
City Postal code Country Position/Affiliation
Dar es Salaam 255 United Republic of Tanzania National Institute for Medical Research and Kilimanjaro Christian Medical University College
Role Name Email Phone Street address
Public Enquiries Michael Mahande jmmahande@gmail.com +255759929965 P.O.Box 2240, MOSHI Tanzania
City Postal code Country Position/Affiliation
Arusha 255 United Republic of Tanzania Kilimanjaro Christian Medical University College
Role Name Email Phone Street address
Scientific Enquiries Sayoki Mfinanga gsmfinanga@yahoo.com +255784755632 P.O.Box 3436, Dar es Salaam
City Postal code Country Position/Affiliation
Dar es Salaam 255 United Republic of Tanzania Program Supervisor National Institute for Medical Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data are available from the corresponding author upon reasonable request including filling data transfer agreements Informed Consent Form,Study Protocol Data are available from the corresponding author upon reasonable request including filling data transfer agreements Only it requires filling data transfer agreements
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/07/2022 05/03/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/07/2022 Result - 30/07/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information