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

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SLCTR Registration Number

SLCTR/2019/007


Date of Registration

27 Feb 2019

The date of last modification

Mar 03, 2019



Application Summary


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.


Trial Details


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

  1. Two group based interactive discussions on food diversity, of 30 minutes duration each, delivered during week 1 and week 2

  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

  1. Males and females aged 60 years and above

  2. Residing in their area for more than 3 months

  3. 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)

  4. Able to communicate well in Sinhala.


Exclusion criteria

  1. Elderly with Cognitive impairment (assessed using Mini Mental state Examination (MME). A score below 24 will be considered as cognitively impaired)
  2. Elderly residing in elderly homes or day care centers


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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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