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.: PACTR202102840289918 Date of Approval: 02/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of nutrition education on nutritional status, body composition, health and health related quality of life of elderly population in Ilu Ababor Zone, South West Ethiopia
Official scientific title Nutrition and Lifestyle
Brief summary describing the background and objectives of the trial General Objective To assess the Effect of Nutrition Education on Nutritional Status, Body Composition, Health and Health Related Quality of Life of Elderly people in urban and semi-urban areas of Ilu Aba Bor Zone, Southwest Ethiopia, during 2020 – 2021 Specific objectives 1. To determine nutritional status (Chronic Energy deficiency, over weight) of elderly people in urban and semi-urban areas of Illu Ababor Zone, Southwest Ethiopia (base line survey). 2. To evaluate the effect of nutrition education on body composition (waist circumference, body mass index) of elderly people in urban and semi-urban areas of Illu Ababor Zone, Southwest Ethiopia (end line survey). 3. To determine the effect nutrition education on dietary diversity score of elderly people in urban and semi-urban areas of Illu Ababor Zone, Southwest Ethiopia (end line survey). 4. To determine the effect of nutrition education on quality of life of elderly people in urban and semi-urban areas of Illu Ababor Zone, Southwest Ethiopia (end line survey). 5. To determine the effect of nutrition education on self-reported health of elderly people in urban and semi-urban areas of Illu Ababor Zone, Southwest Ethiopia (end line survey). 6. To evaluate the effect of nutrition education on prevalence of hypertension, type 2 DM & dyslipidemia of elderly people in urban and semi-urban areas of Illu Ababor Zone, Southwest Ethiopia (end line survey).
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 Physical activity and nutrition
Anticipated trial start date 10/12/2020
Actual trial start date 20/12/2020
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 10/07/2021
Anticipated target sample size (number of participants) 508
Actual target sample size (number of participants) 508
Recruitment status Closed to recruitment,follow-up continuing
Publication URL www.Pubmed.org
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Nutrition and physical activity Behavioral change education on diet diversity and physical activity will be given every month in clusters for participants and caregivers of the intervention group for five months For five months The intervention focus on behavior change concerning healthy lifestyles 254 Dose Comparison
Experimental Group Nutrition and Physical activity Provide information on: • Advantages of diversified diet (healthy food consumption) • Disadvantage of physical inactivity • Risky behaviors (unhealthy lifestyle) • Metabolic syndrome, its risk factors and consequences Environmental issues • Food access, availability & affordability • Peer & family support • Income • Mass media Mastery experiences Performing intended behavior during nutrition education class or during the practice session to encourage self-efficacy in order to increase; Physical activity, healthy food choosing and/or purchasing, healthy lifestyle Goal setting • Problem identification & prioritization • Conducting assessment for planning • Setting vision • Attainable goal setting • Setting SMART objectives to attain the goal Vicarious experiences  Facilitating role play, demonstration and simulating of brisk walking and physical exercise  Video show Verbal motivation • Healthy food shopping • Physical activity • Healthy life style • Healthy eating Outcome expectations Encourage to dream up: Better quality of life, normal body composition, self-confidence & independence The intervention will be started at baseline and in 5 Months • Nutrition education on the health benefits of diversified diet intake emphasizing on serving more cereals, vegetables and fruits on a daily basis. • Avoid eating and drinking sweet foods • Moderate physical activity of 30-min per day at least 3days in a week • Ethiopian balanced diet and staple foods which are less in fat and higher in fibers. • Reducing salt intake • Serve more less fat dairy products • Serve more sea foods • Avoid saturated fat intake • Elderly and caregivers in the intervention group will be gathered every week to create bonding and peer support. • Access to food will be increased through distributing leaflets with key messages every time to elderly and caregivers in the intervention group attending the nutrition education class • The caregivers will strive in passing information obtained during health education, education, class for families, peers and supporters • Nutrition education on healthy foods purchasing considering most prioritized item (cereals, fruits and vegetables) • Nutrition education on health behaviors • Education on moderate exercise such as brisk walking with demonstration * Participants form a small team and have a practical session concerning how to overcome barriers towards elderly nutritional & metabolic syndrome problems and encourage elderly and caregivers to design strategies and seek solutions in talking the issues from their own perspectives. • The motivational interviewing, will be delivered during home visit emphasizing on performing daily physical exercise, healthy food choosing and /or purchasing, cope up with challenges affirmatively. • Improving self-efficacy to achieve set objectives and goals • The outcome expectation will drive the elderly to attain the desired behavior change 254
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All elderly people aged 60 years and above who are residents of the selected urban and semi urban areas and plan to stay in the study area for the next six months of the study period will be included in the study.  Those elderly who planned to leave the study area for the period of data collection and intervention sessions (Unable to complete the intervention for 6 months).  Elderly who cannot walk.  Cannot participate due to serious illness or contraindicated to involve in physical activities  Elderly people who are with generalized body swelling will be excluded from the study. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 80 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 04/11/2019 Institute Review Board Institute of health Jimma University
Ethics Committee Address
Street address City Postal code Country
Jimma Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body Mass index At base line and End line
Secondary Outcome Waist Circumference measurement At baseline and in 6 months
Secondary Outcome Status of HR-QOL At baseline and at 6 month
Secondary Outcome Self -reported health status at baseline and at 6 month
Secondary Outcome Blood pressure At baseline and at 6 month
Secondary Outcome Type II diabetes mellitus at baseline and at 6 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The recruitment center includes Urban areas namely Mettu and Groe Town semi urban areas will be Bure Sibo Uka Nopa Hurumu Yayo NA Cities of each urban and semi urban areas NA Ethiopia
Gore Town Not applicable Gore NA Ethiopia
Ukka Not applicable Ukka NA Ethiopia
Sibo Not applicable Sibo NA Ethiopia
Bure Not applicable Bure NA Ethiopia
Nopa NA Nopa NA Ethiopia
Hurumu NA Hurumu NA Ethiopia
Yayo NA Yayo NA Ethiopia
Metu Town NA Metu NA Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Muluneh Shuremu Mettu Mettu NA Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mettu University Mettu Mettu 318 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muluneh Shuremu mulunehshuremu@gmail.com +251911912385 Mettu
City Postal code Country Position/Affiliation
Mettu NA Ethiopia Instructor
Role Name Email Phone Street address
Public Enquiries Lakew Abebe lakewgebretsadika9@gmail.com +251917823144 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Peer
Role Name Email Phone Street address
Scientific Enquiries Teferra Belachew teferabelachew2@gmail.com +251917804072 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Advisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Not available Informed Consent Form,Statistical Analysis Plan,Study Protocol 1year The access to data is controlled and all related analysis of data is possible to access, the data can be accessed via formal query forwarded to the advisor and principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www. Pubmed.org 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