UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041346 |
|---|---|
| Receipt number | R000047128 |
| Scientific Title | Community-based lifestyle intervention for diabetes management in rural Nepal |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2024/02/11 13:54:53 |
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Basic information
Public title
A cluster randomized trial of a community-based lifestyle intervention for diabetes management in Kavrepalanchowk and Nuwakot district of Nepal.
Acronym
CoLID-Nepal
Scientific Title
Community-based lifestyle intervention for diabetes management in rural Nepal
Scientific Title:Acronym
CoLID-Nepal
Region
| Asia(except Japan) |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of a culturally appropriate lifestyle intervention (using a combination of community health workers, peer supporters and regular telephone calls) in improving management and care of people with type 2 diabetes mellitus (T2DM) in Kavrepalanchowk and Nuwakot districts of Nepal.
Basic objectives2
Others
Basic objectives -Others
1. To determine the effectiveness of a culturally appropriate lifestyle intervention
2. To assess the intervention adherence, study retention and measures-completion rates.
3. To estimate/ calculate the likely costs (Health systems and societal) of the lifestyle intervention.
4. To determine the common facilitators and barriers and potentials of scale up.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c at 6 months after the intervention
Key secondary outcomes
quality of life, diabetes distress, blood pressure, waist circumference, body weight, body mass index (BMI), physical activity levels, diet, oral health quality of life, health care utilization, episodes and use of telephone calls with Community Health Workers (CHWs) etc.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The community based intervention will comprise of combination of following activities.
1. Trained community health workers (CHW) deliver sessions to tell diabetes patients how important lifestyle intervention is.
2. Peer support system for diabetes patients will be delivered.
3. CHW will make regular telephone calls to diabetes patients to discuss and advice on the issues of living with and managing diabetes and better management and care.
Interventions/Control_2
Control
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults, age group from 30 to 70 years who are clinically diagnosed with T2DM with their baseline HbA1c is greater than 6.5% will be included based on the American Diabetes Association (ADA) and WHO criteria for diagnosis and classification of diabetes.
Key exclusion criteria
1. Clinically diagnosed with type 1 diabetes mellitus
2. Currently pregnant, and
3. Critically ill patients who have no ability to participate in the program.
Target sample size
422
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Sakamoto |
Organization
Tokyo Women's Medical University
Division name
Section of Global Health, Division of Public Health, Department of Hygiene and Public Health
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-5269-7422
sakamoto.haruka@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Hanako |
| Middle name | |
| Last name | Iwashita |
Organization
Tokyo Women's Medical University
Division name
Section of Global Health, Division of Public Health, Department of Hygiene and Public Health
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-5269-7422
Homepage URL
iwashita.hanako@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University, Section of Global Health, Division of Public Health, Department of Hygiene and Public Health
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Tokyo Women's Medical University
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
krinri.bm@twmu.ac.jp
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
| 2020 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1186/s13063-023-07451-5
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1186/s13063-023-07451-5
Number of participants that the trial has enrolled
481
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The analysis has not been completer.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
