UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045288 |
|---|---|
| Receipt number | 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 05:00:36 |
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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
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
jeews98@gmail.com
Sponsor or person
Institute
National Center for Primary Care & Allergy Research, University of Sri Jayewardhanepura, Sri Lanka
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051727
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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