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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909866468898 Date of Registration: 30/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of therapeutic lifestyle change on metabolic syndrome and health related quality of life among adults in Mekelle city, Northern Ethiopia.
Official scientific title Metabolic Syndrome
Brief summary describing the background and objectives of the trial Summary Background: Premature mortality from NCDs constitutes one of the major challenges for development in the 21st century. The prevalence of metabolic syndrome is more in the urban population of some developing countries than Western counterparts. In addition, the risk of dying prematurely from NCDs in a low or lower-middle- income country is almost double that in high-income countries. Non-communicable disease accounts for 39% of deaths in Ethiopia among all groups and 18% among 30-70year age group. Objective: the aim of this study is to measure the effect of therapeutic lifestyle change on metabolic syndrome and health related quality of life among adults living in Mekelle city. Method: For measuring the effect of therapeutic lifestyle change on metabolic syndrome and quality of life, 150 individuals aged 40-64 years with metabolic syndrome will be recruited from the seven sub-cities of Mekelle city. Two arm randomized controlled trial will be used as a study design with 75 study participants in each arm. After collecting baseline data, participants will be followed for three months with baseline training for half day and biweekly provision of counseling. Dietary, weight management and physical activity are the three components of therapeutic lifestyle change that will be given for the intervention arm. Different statistical techniques will be used for analysis like t-test, logistic regression, linear regression, and GEE depending on the type of outcome variable. All variables will be considered significant at p<0.05. Expected outcomes: the effect of therapeutic lifestyle change on metabolic syndrome and quality of life will be objectively measured. Work plan: the study will be accomplished from October 15, 2019 – January 13, 2020 G.C Budget: the study will require a total budget of 4,000 US Dollar.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MetS
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 15/10/2019
Actual trial start date
Anticipated date of last follow up 13/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Therapeutic lifestyle change Baseline training (4 hours); 6 times counseling for 1 hour each (every 2 weeks starting from baseline); weekly message reminder; and 30 minutes daily (5 days a week) physical activity. Three months Therapeutic Lifestyle change (dietary counseling, weight management and physical activity). 75
Control Group No intervention will be given no no no 75 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals with metabolic syndrome according to International diabetic criteria (IDF) criteria; Age of 40-64 years; Absolute contraindication for physical activity due to known musculoskeletal, neurological, vascular, lung and cardiac problems; Subjects who will be pregnant or lactating women (first year); If on medication for MetS-related health conditions such as hypertension, dyslipidemia, and diabetes; Individuals with major illness; Use of medications known to hinder improvements in metabolic syndrome components. Involving in another physical activity program Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 30/07/2019 Jimma University Ethical Review Board
Ethics Committee Address
Street address City Postal code Country
Jimma city Jimma city 1378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Presence/absence of metabolic syndrome At baseline and end of intervention
Secondary Outcome The five components of metabolic syndrome (waist circumference, fasting blood glucose, blood pressure, high-density lipoprotein, and triglyceride), body weight, blood cholesterol, low-density lipoprotein, body mass index and quality of life. At baseline and end of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mekelle city The whole city Mekelle city Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Jimma city Jimma city 1378 Ethiopia
Adigrat University Adigrat city Adigrat city 7050 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Jimma city Jimma city 1378 Ethiopia University
Secondary Sponsor Adigrat University Adigrat city Adigrat city 7050 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Adigrat University Adigrat city Adigrat city 7050 Ethiopia
Jimma University Jimma city Jimma city 1378 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gebremedhin Gebreegziabiher ghingherg@gmail.com +251914754562 Ayder sub-city
City Postal code Country Position/Affiliation
Mekelle city 7050 Ethiopia Assistant professor and PhD Fellow at Jimma University
Role Name Email Phone Street address
Public Enquiries Dessalegn Tamiru dessalegn97@gmail.com +251912373397 Jimma city
City Postal code Country Position/Affiliation
Jimma city 1378 Ethiopia Associate professor and instructor at Jimma Uiversity
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew teferabelachew@gmail.com +251917804072 Jimma city
City Postal code Country Position/Affiliation
Jimma city 1378 Ethiopia Professor in Human Nutrition and instructor at Jimma University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD will be disclosed to publishing Journals and for individuals and organizations who need the data using controlled system. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol We will make the IPD available starting from the completion of the trial for the next 3 years. Access criteria:- controlled system (health offices in government hierarchies, scientific community with a qualification of PhD fellow and above and publishing journal responsible to publish the result). Type of data analysis permitted:- descriptive, GEE, t-test and systematic review and Meta-analysis. Process for requesting data:- by writing request letter through email. Who will decide:- Jimma University.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet established Yes The result of this trial will be published 12 months after the completion of the study. 15/01/2021 15/09/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Not hyperlinked for the moment
Changes to trial information