Home » Trials » SLCTR/2019/007
Effectiveness of a Nutrition education intervention in improving under nutrition among elderly in Colombo District; A non-randomized controlled trial
-
SLCTR Registration Number
SLCTR/2019/007
Date of Registration
The date of last modification
Sep 16, 2020
Scientific Title of Trial
Effectiveness of a Nutrition education intervention in improving under nutrition among elderly in Colombo District; A non-randomized controlled trial
Public Title of Trial
Effectiveness of a nutrition education intervention in improving dietary diversity among elderly with undernutrition in Colombo District; A non-randomized controlled trial
Disease or Health Condition(s) Studied
Nutrition in the elderly
Scientific Acronym
None
Public Acronym
None
Brief title
Effect of Nutrition education on under nutrition among elderly
Universal Trial Number
UIIII-1226-1778
Any other number(s) assigned to the trial and issuing authority
P/123/6/2018 Ethical Review Committee, Faculty Of Medicine, University Of Kelaniya.
What is the research question being addressed?
What is the effect of a nutrition education intervention in improving under nutrition among elderly in the Colombo District?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Single blinded : Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study Setting: two Divisional Secretariat Divisions (DS) in Colombo District. This is a quasi-experimental study. Study duration: three months.
Intervention group: Elderly with under nutrition in Moratuwa DS Division. Control group: Elderly with under nutrition in Kesbewa DS Division.
A Nutrition education package will be delivered by a trained team of facilitators. The Nutrition education package is composed of two modules with defined objectives.
Module one objectives:
1. To improve the diversity of the diet consumed by the elderly.
2. To improve the variety of food items consumed by the elderly.
Module two objectives
1. To improve the serving sizes of the food groups (as recommended) of the elderly.
2. To get the elderly participation in decision making process in relation to dietary pattern (for primary care givers of the elderly)
Module one interventions
Two group based interactive discussions on food diversity, of 30 minutes duration each, delivered during week 1 and week 2
Two group based interactive discussions on food variety, of 30 minutes duration each, delivered during week 1 and week 2
Module two interventions
1.Two group based lecture discussions on food serving sizes, of 30 minutes duration each, delivered during week 1 and week 2.
2.Two group based lecture discussions on participation of elderly in diet related decision making process, of 60 minutes duration each, delivered during week 1 and week 2.
Standard care: the control group will not receive the intervention and they receive standard information from the health system through health care institutions, media, publications and contact persons in daily routine.
Blinding: only the outcome assessors will be blinded.
Inclusion criteria
Males and females aged 60 years and above
Residing in their area for more than 3 months
Undernutrition as determined by the presence of one or more of the following criteria
• BMI value less than 18.5 KgM-2 OR
• Body fat percentage less than 26% in females and less than 14% in males (Gallagher et al., 2000) OR
• Body muscle percentage less than 26.6 % in females and less than 34.4% in males (Tichet et al., 2008) but, fat percentage within normal range. Measurements by portable Body composition analyzer (Omron, HBF- 212, Japan)
Able to communicate well in Sinhala.
Exclusion criteria
Primary outcome(s)
|
1.
Improvement of the Dietary Diversity of the dietary pattern among the participants. This will be assessed by using a 24-hour dietary recall method and assessed using a score. The dietary diversity score has been used as a proxy indicator of nutrition adequacy of rural elderly people in Sri Lanka (Rathnayake et al, 2012) |
[ Time point: At baseline, at two weeks after the complete implementation of the intervention package, and at 3 months after the complete implementation of the intervention package ] |
Secondary outcome(s)
|
1.
Improvement of the Food Variety and Dietary Serving of the Dietary pattern among the participants. This will be assessed by using a 24-hour dietary recall method and assessed using a score. The dietary diversity score has been used as a proxy indicator of nutrition adequacy of rural elderly people in Sri Lanka (Rathnayake et al, 2012) |
[ Time point: At baseline, at two weeks after the complete implementation of the intervention package, and at 3 months after the complete implementation of the intervention package to determine the sustainability of the intervention. ] |
Target number/sample size
120 (60 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-03-01
Anticipated end date
2019-06-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-12-11
Approval number
P/123/06/2018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. K.D.S.C.Vijewardane
Registrar in Community Medicine
Faculty Of Medicine
Kotelawela Defence University,
Sri Lanka
Tel: +94-112638660
Mob: +94-718232978
Fax: +94-112638660
samanthachampika@gmail.com
Contact Person for Public Queries
Dr. Aindra Balasuriya
Head, Department of Public Health
Faculty Of Medicine.
Kotelawela Defence University,
Sri Lanka
Tel: +94-112638660
Mob: +94-718427086
Fax: +94-112638660
dr.balasuriya@yahoo.com
Primary study sponsor/organization
Department of Public Health, Faculty Of Medicine. Kotelawela Defence University, Sri Lanka
Kandawala Road, Rathmalana 10390
Sri Lanka
Tel: 0112638660
Fax: 0112638660
paraclinicalsciences.kdu@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results reported in published articles will be shared after de-identification (text, tables, figures and appendices). The study protocol will not be available. Data will be made available beginning 9 months and ending 36 months following article publication, to researchers who provide methodologically sound proposals, and to achieve the aims of the approved proposal. Proposals can be submitted up to 36 months following article publication. Thereafter data will be available at the University warehouse with the investigator supported access. The link of access will be provided.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
