UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000045288
Receipt No. R000051727
Scientific Title Prevalence of under nutrition, food diversity and the effectiveness of a health education programme in improving the nutritional status and food diversity, among elders attending selected Primary Health Care settings in Colombo District of Sri Lanka.
Date of disclosure of the study information 2022/08/26
Last modified on 2021/08/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prevalence of under nutrition, food diversity and the effectiveness of a health education programme in improving the nutritional status and food diversity, among elders attending selected Primary Health Care settings in Colombo District of Sri Lanka.
Acronym Prevalence of under nutrition, food diversity and the effectiveness of a health education programme in improving the nutritional status and food diversity, among elders attending selected Primary Health Care settings in Colombo District of Sri Lanka.
Scientific Title Prevalence of under nutrition, food diversity and the effectiveness of a health education programme in improving the nutritional status and food diversity, among elders attending selected Primary Health Care settings in Colombo District of Sri Lanka.
Scientific Title:Acronym Prevalence of under nutrition, food diversity and the effectiveness of a health education programme in improving the nutritional status and food diversity, among elders attending selected Primary Health Care settings in Colombo District of Sri Lanka.
Region
Asia(except Japan)

Condition
Condition prevalence of undernutrition
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To detect the prevalence of undernutrition, factors associated with undernutrition, dietary diversity and the effectiveness of a health education programme in improving nutritional status and dietary diversity among elders attending selected Primary Care settings in the Colombo District of Sri Lanka.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement in the dietary diversity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Health education for 6 months duration.
Interventions/Control_2 No health education
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Elders >= 60 years
Presenting to primary care centers
Key exclusion criteria 1.Elderly who got communication and understanding problems
2.Patients who were on enteral/ parenteral nutrition or on nutritional supplementation
3.Bed ridden
4.Patients diagnosed with terminal illness
Target sample size 400

Research contact person
Name of lead principal investigator
1st name R. M. JEEWANTHI
Middle name CHAMARI
Last name SOMARATNA
Organization UNIVERSITY OF COLOMBO, SRI LANKA
Division name POSTGRADUATE INSTITUTE OF MEDICINE
Zip code 00700
Address 150, WEWELDUWA, KELANIYA 11600, SRI LANKA
TEL 0094773792364
Email jeews98@gmail.com

Public contact
Name of contact person
1st name R. M. JEEWANTHI
Middle name CHAMARI
Last name SOMARATNA
Organization UNIVERSITY OF COLOMBO, SRI LANKA
Division name POSTGRADUATE INSTITUTE OF MEDICINE
Zip code 00700
Address 150, WEWELDUWA, KELANIYA 11600, SRI LANKA
TEL 0094773792364
Homepage URL
Email jeews98@gmail.com

Sponsor
Institute National Center for Primary Care & Allergy Research, University of Sri Jayewardhanepura, Sri Lanka
Institute
Department

Funding Source
Organization National Center for Primary Care & Allergy Research, University of Sri Jayewardhanepura, Sri Lanka
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Sri Jayewardhanepura
Address Gangodawila, Nugegoda, Sri Lanka
Tel 0094072111184
Email jeews98@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 26 Day

Related information
URL releasing protocol Not applicable
Publication of results Partially published

Result
URL related to results and publications https://www.ccp.lk/annual-academic-sessions-2021/
Number of participants that the trial has enrolled 400
Results Prevalence of undernutrition among elders in Colombo district is high.
Prevalence of anaemia in the population was significant.
Poor adherence to the health education intervention.
Results date posted
2021 Year 08 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Poor adherence to the health education instructions
Participant flow At the beginning steady & mild reduction at the end.
Adverse events None
Outcome measures Improvement in anthropometric parameters and Hb concentration.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 04 Month 08 Day
Date of IRB
2017 Year 06 Month 17 Day
Anticipated trial start date
2017 Year 08 Month 26 Day
Last follow-up date
2020 Year 04 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 08 Month 28 Day
Last modified on
2021 Year 08 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.