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.: PACTR202003465339638 Date of Approval: 24/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Behaviour Change Communication on Metabolic Syndrome, its Markers and Body Composition among Employees of Jimma University, Southwest Ethiopia: Randomized Controlled Trial.
Official scientific title Effect of Behaviour Change Communication on Metabolic Syndrome, its Markers and Body Composition among Employees of Jimma University, Southwest Ethiopia: Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Study area and Period The study participants were recruited from Jimma University, which is a public higher educational institution established in December 1999. Jimma city 335 km southwest of Addis Ababa. The university two institutes and six colleges encompassing a total of 1300 academic and 4450 administrative staffs. Circumstantial evidences show components of metabolic syndrome such as diabetes mellitus, hypertension and cardiovascular problems are common even within the small circle of academic and administrative staff leading to morbidity and mortality tolls. Study Design An individually randomized controlled trial was carried out to determine the effect of nutrition BCC on markers of metabolic syndrome and body composition. The baseline study recruited 705 workers of Jimma University, which was used for developing anthropometric cut-offs for Ethiopian adults (Sinaga et al., 2018). From the baseline study participants, a total of 230 individuals (intervention, n=115 and control, n=115) were randomly selected using the baseline identification number as a sampling frame. The intervention group was given behaviour change communication through different strategies including power point sensitization, facilitated group discussion using real examples of cases with metabolic syndrome and Power point presentation and discussion of evidences on metabolic syndrome and effective dietary and life style behaviours. The subjects were also reminded about the behaviours using key mottos of the behaviour (eg. Your menu should be colourful….) that were emphasized during training through text messages, while the control group received nothing before data collection . Once the end line data were collected a similar education was given to the control group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BBC
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 15/09/2015
Actual trial start date 15/09/2015
Anticipated date of last follow up 15/01/2016
Actual Last follow-up date 15/01/2016
Anticipated target sample size (number of participants) 230
Actual target sample size (number of participants) 224
Recruitment status Completed
Publication URL NA
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition and life style behaviour chnage communication The intervention was given for three months with the following approaches 1. Leaflets in the local language were given at the beginning 2. Power point presentation and discussion on the up-to-date evidences on metabolic syndrome its markers and body composition were made for every 5-10 people from the intervention group once per month(3 times) 3. A text message containing the key messages e,pjasized during the discussions were ,ade to each intervention group, every 15 days. The follow up was for three months The intervention was given for three months with the following approaches 1. Leaflets in the local language were given at the beginning 2. Power point presentation and discussion on the up-to-date evidences on metabolic syndrome its markers and body composition were made for every 5-10 people from the intervention group once per month(3 times) 3. A text message containing the key messages e,pjasized during the discussions were ,ade to each intervention group, every 15 days. 112
Control Group Behavioral chnage communication on nutrition and life styles none 3months Leaflets were distributed and education was given to the control group after the end of the follow up(after endline data were collected). 112 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Not having any physical disability that interferes with anthropometry Being employ of Jimma University Being seriously sick Not available for the total duration of the follow up Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 05/02/2015 Jimma University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Ginjo Jimma 1104 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difference of the differences in Metabolic syndrome and its markers, body composition Endline survey
Secondary Outcome Differences in lipid profiles endline survey
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jimma University Ginjo Jimma 1104 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Institute of Health Gonjo City 1104 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Ginjo Jimma 1104 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dr.Tilahun Yemane Ginjo Jimma 1104 Ethiopia
Dr.Elsah Tegene Ginjo Jimma 1104 Ethiopia
Prof.David Lindstrom Bron University, Rhjode Island Providence United States of America
Makeda Sinaga Ginjo Jimma 1104 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Makeda Sinaga makedasinaga@gmail.com +251917804239 Ginjo
City Postal code Country Position/Affiliation
Jimma 1104 Ethiopia Jimma University
Role Name Email Phone Street address
Scientific Enquiries Dr.Tilahun Yemane yemanetilahun@yahoo.com +251917804067 Ginjo
City Postal code Country Position/Affiliation
Jimma 1104 Ethiopia Jimma University
Role Name Email Phone Street address
Principal Investigator Tefera Belachew teferabelachew@gmail.com +251917804072 Ginjo
City Postal code Country Position/Affiliation
Jimma 1104 Ethiopia Jimma University
Role Name Email Phone Street address
Public Enquiries Tefera Belachew teferabelachew@gmail.com +251917804072 Ginjo
City Postal code Country Position/Affiliation
Jimma 1104 Ethiopia Jimma University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data with all coding and syntax for the models will be available upon request. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol One year The data will be availed for scientific use only upon formal request to the PI.
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