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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041346
Receipt No. 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 2021/02/06

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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 12 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
64 years-old >=
Gender Male and Female
Key inclusion criteria Adults, age group from 30 to 60 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 576

Research contact person
Name of lead principal investigator
1st name Tomohiko
Middle name
Last name Sugishita
Organization Tokyo Women's Medical University
Division name Department of International Affairs and Tropical Medicine
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-5269-7422
Email sugishita.tomohiko@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 Department of International Affairs and Tropical Medicine
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-5269-7422
Homepage URL
Email iwashita.hanako@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University, Department of International Affairs and Tropical Medicine
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
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
2021 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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