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Trial registered on ANZCTR


Registration number
ACTRN12621000531819
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
6/05/2021
Date last updated
1/06/2023
Date data sharing statement initially provided
6/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Community-based lifestyle intervention for diabetes (CoLID - study) management in rural Nepal: A Clustered Randomized Control trial.
Scientific title
Effectiveness of a cluster-randomized trial of a community-based lifestyle intervention on hypoglycaeted haemoglobin (HbA1c) levels in people with type 2 diabetes in Kavrepalanchowk and Nuwakot districts of Nepal.
Secondary ID [1] 303463 0
Nil
Universal Trial Number (UTN)
Trial acronym
Community-based lifestyle intervention for diabetes (CoLID- study) management in Nepal
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with clinically diagnosed Type 2 diabetes 320769 0
Condition category
Condition code
Metabolic and Endocrine 318596 318596 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, community-based, single-blinded end-point assessment, 2-arm randomized controlled trial
The initial assessment and screening will be performed at local community health centers, Dhulikhel Hospital outreach centers, and satellite health camps. We will recruit a total of 576 (288 in Nuwakot + 288 in Kavrepalanchowk) participants with type 2 diabetes with Hb1Ac equals 6.5% from 16 clusters from each district. Among 288 participants in each district, 144 participants will be randomly selected for the intervention and control group.
Intervention
The community-based intervention will comprise of a combination of an intensive group-based monthly education session, focus group discussion, on-going support mechanism, monitoring, and follow up based on the Chronic NCDs self-management programs. This will include a combination of dietary measures, stress management/problem solving, ways to stay away from triggers to drink alcohol and smoke, diabetes medications, diabetes literacy, monitoring blood sugar level, physical activity, health care utilisation, oral health and quality of life.
Dietary recommendations include reduction of unhealthy fat intake and increase in vegetable consumption based on the availability and acceptability of the local food with moderate calorie restriction in the overweight/ obese population.
Exercise recommendation includes 15 minutes of moderate physical activity on all or most days of the week based on the acceptability of the exercise in the society which is found to be effective in developed settings. We will adopt components of the Peers for Progress modules of peer support which includes 12 modules to develop our culturally tailored diabetes self-management program which will include
1. Trained community health workers/peer leaders will facilitate two hours monthly session to participants selected for the intervention group after randomization. The monthly 2 hours session will last for 12 months. This is the estimated time that we think will need for each session. However, depending on the topic and way discussion goes, the 2 hours session may go little longer or shorter. We estimate there will be 10-12 participants in each cluster who will then participate in the monthly sessions.
2. The intervention will include 12 modules including general understanding of diabetes; healthy eating; regular physical activity; social and emotional support; seeking health care; utilization of health services; dealing with abnormal conditions while living with diabetes etc.
3. Regular contact with participants (conducting a meeting with participants once a month);
4. A structured, state-of-the-art, session related to intervention for self-management strategies by healthy eating, physical activity, quit smoking, reduce harmful use of alcohol, and weight loss etc. These are not separate to 2 hours session. These approaches will be used while conducting 2 hours monthly sessions.
5. 12 supervised intervention sessions facilitated by trained community health workers for 12 months (monthly basis) of the intervention duration. Peer supporters who also have similar conditions as other diabetic patients will also offer social and emotional supports;
6. Tailoring of materials and strategies to address ethnic diversity. We will develop an intervention package both in the English language and Nepali language. We will also develop adequate Information, Education and Communication (IEC) materials (flex, charts, flip chart, and flashcards) to deliver the intervention package.
7. We are at the moment working on developing automated telephone call systems, which will help our project team to deliver messages (general and project intervention related) to all participants. We plan to send the relevant message to intervention participants at lease one a month. However, depending on the situation the frequency of message may increase. Further, when needed our project team members will make calls to participants directly. We will also provide our project contact (telephone number as well as the hotline number) to contact our project team when needed.
8. We believe on the power of collaboration with different sectors, in particularly with the Government. We have been collaborating with Ministry of Health Nepal for several health related programs and for this project too we have been collaborating with government health centers for implementing project intervention activites in Kavrepalanchowk and Nuwakot distrcts.
Control participants: We will provide pictorial brochure on diabetes self-management education developed in Nepali language to the control participants in order not to deprive them from having awareness and understanding on diabetes self-management. They will continue to receive usual care available in both Kavrepalanzhowk and Nuwakot districts of Nepal.

Incentives: We will provide a small snacks and tea/ coffee during the monthly CHW-led two hours session. No financial incentives will be provided.
Contact details: We will provide our project contact details to the participants such that they could contact us as per their need. Monthly meeting with the research team and health care workers: The research team, health workers will join the peer-led maintenance session and collect the monthly records kept by the peer leader.
Monitoring of intervention and monthly session:
Our project team located at Dhulikhel hospital, Kathmandu University, will be in regular contact with CHWs and peer supporters. That will help us determining how the things are going on and address any challenges/ issues they may face in the meantime. Further, our project team members will make unannounced random visit to the monthly sessions in order to ensure that the monthly sessions are happening as planned and resolve the problems on the spot which the CHWs or peer supporters may have faced.
On top of that, we will organize quarterly meeting with all CHWs and Peer supporters separately, in order to review the progress of the monthly sessions and address the issues/ challenges they may be facing. Further, we will organize a monthly drop-in session (via phone/ or WhatsApp/ Viber or Zoom), just in case any CHW has anything to say on the intervention part of the project. In general, our project team members are already get used to with these two districts and they have been connected with most of the CHWs in the districts. Regular formal/ informal communication will continue to take place to ensure the intervention activities are happening effectively and smoothly.
Training to CHWs and Peer supporters:
Given the ongoing COVID-19 pandemic including in Nepal, we will adopt combination of both online as well as face-to face approaches to train our CHW and Peer leaders, who will then facilitate the 2 hours monthly sessions to participants with T2DM.
The CHWs of intervention clusters will receive two days training facilitated by the Endocrinologist, Nutritionist, Psychologist and Research Investigators. The training will mainly focus on providing diabetes self-management support using non-pharmacological intervention approaches. However, the patients will need medication when needed. The training will be held one in kavrepalanchowk district and one in Nuwakot district.
Similarly, we will organize one day Peer supporters training – one in Kavrepalanchowk district and one in Nuwakot district. The training will mainly focus on working with peers; importance of social, family and emotional support; importance of social network; listening skills; and group facilitation and communication/ coordination skills etc.
Intervention code [1] 319752 0
Lifestyle
Intervention code [2] 319753 0
Behaviour
Comparator / control treatment
We will provide a pictorial brochure on diabetes prevention education written in the Nepali language to the control participants in order not to deprive them of awareness relating to diabetes management. We have developed diabetes education brochures in line with the government of Nepal, Ministry of health suggested information and process. These brochures are being developed mainly for the purpose of this project.
They will continue to receive the usual care available in Kavrepalanchowk and Nuwakot districts..
Control group
Active

Outcomes
Primary outcome [1] 326557 0
Hypoglycaeted Haemoglobin (HbA1c) levels
Timepoint [1] 326557 0
Baseline and 6 months of post-intervention
Secondary outcome [1] 391859 0
Quality of life using SF-8 and EQ-5D questionnaire
Timepoint [1] 391859 0
Baseline and 6 months of post-intervention
Secondary outcome [2] 392953 0
Diabetes distress and depression using PSS and PHQ-9 tools.
Timepoint [2] 392953 0
Baseline and 6 months after the intervention.
Secondary outcome [3] 392954 0
Diabetes-related symptoms and severity details using Nepal Demographic and Health survey questionnaire and WHO STEPS survey questionnaire
Timepoint [3] 392954 0
Baseline and 6 months of post-intervention
Secondary outcome [4] 392955 0
Behavioral characteristics including information on physical activity, smoking, alcohol intake data using GPAQ questionnaire and the questions adapted from NDHS and WHO STEPS survey questionnaire
Timepoint [4] 392955 0
Baseline and 6 months of post-intervention
Secondary outcome [5] 394317 0
Blood pressure related details using NDHS survey questionnaire and WHO STEPS survey questionnaire
Timepoint [5] 394317 0
Baseline and 6 months of post-intervention
Secondary outcome [6] 394318 0
Waist circumference will be assessed by using World Health Organization STEPS survey questionnaire
Timepoint [6] 394318 0
Baseline and 6 months of post-intervention
Secondary outcome [7] 394319 0
Total blood cholesterol test by using laboratory blood sample test.
Timepoint [7] 394319 0
Baseline and 6 months of post-intervention
Secondary outcome [8] 394320 0
The following WHO recommended standard protocol will be used to measure body weight:
WEIGHT MEASUREMENT GUIDELINES
1. Percipient will be informed about the body weight measurement prior to commencing the measurement procedure.
For the procedure
Stand upright on a bathroom scale with a barefoot
Keep heels separated without holding anything
Record the weight in kilogram
Say this to participants
Light clothing?
See at 90 degrees (do not look down)
Say this to participants: Now I will measure your weight
2. Record the weight in Kg

References:
World Health Organization, STEPS Survey questionnaire
Timepoint [8] 394320 0
Baseline and 6 months of post-intervention
Secondary outcome [9] 394321 0
The body mass index (BMI) will be calculated by using WHO-recommended formula (using body weight and height) which is explained as follows:

Firstly, the weight will be measured by using a bathroom scale
Secondly, height will be measured in a stadiometer which will be recorded in centimeters.
Then, we will calculate BMI by using standard formula i.e.
BMI=weight in kilograms divided by the square of the person’s height in meters (kg/m2)
Timepoint [9] 394321 0
Baseline and 6 months of post-intervention
Secondary outcome [10] 394322 0
Diet will be assessed by using 24 hours diet recall guidelines as recommended by National Cancer Council guidelines
Timepoint [10] 394322 0
Baseline and 6 months of post-intervention
Secondary outcome [11] 394323 0
Oral health quality of life will be measured using 14 item Oral Health Impact Profile (OHIP-14) tools as validated by Slade GD, 1997.
Reference:
Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x. PMID: 9332805.
Timepoint [11] 394323 0
Baseline and 6 months of post-intervention
Secondary outcome [12] 394324 0
Health care utilization will be used by using GPAQ tools as validated and recommended by University of Cambridge: http://www.phpc.cam.ac.uk/gpaq/files/2014/08/GPAQ-R2.pdf

Reference:
University of Cambridge, GPAQ tools: Available at: https://www.phpc.cam.ac.uk/gpaq/
Timepoint [12] 394324 0
Baseline and 6 months of post-intervention

Eligibility
Key inclusion criteria
Adults, the 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.
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically diagnosed with type 1 diabetes mellitus, Currently pregnant, and Critically ill patients who have no ability to participate in the program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization of clusters will take place once the baseline measures are being collected. Concealed allocation will be used to randomize the clusters, not the participants. The statistician who is not associated with the study will perform randomization of the clusters.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). The statistician who is not associated with the study will perform randomization of the clusters.
The unit of randomization will be the Health facility located in the particular village municipality.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomization
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Formative phase (year I): A. Quantitative data: The health survey will be administered using JavaRosa based system software and paper-based questionnaires where necessary. Then the information from the facility survey questionnaire will be entered into excel by the project coordinator.

The data will be then cleaned and analyzed to provide a descriptive summary for accounting for the sampling weights in each facility survey on the following objectives.
I) Health service statistics on a number of diabetes mellitus (DM)and hypertension (HTN) cases of last year and follow up cases of DM and HTN with their registrations and producers.
II) Assess basic infrastructure facility and functional equipment for the provision of routine investigation like weighing machine, BP apparatus, glucometer with glucostrip and processes to provide quality health services to diabetes patients by using NCDs guideline.
III) Procedures for routine and B. Qualitative data: Qualitative data will be collected through KII and health facility in charge at the selected facility. Researchers carrying out participant observations will keep daily field notes, which will be regularly typed up directly into RQDA (R package for Qualitative Data Analysis) will be confidentially shared and jointly coded by the research team.
IV) MP3 audio files, transcripts will be read and re-read by researchers independently developed an initial coding matrix of them and categories of interviews, and interview notes will be uploaded directly into RQDA (R package for Qualitative Data Analysis).
For the impact of Covid 19, both the descriptive statistical analyses and inferential statistical analyses (depending on the sample and data) will be used for quantitative data, whereas thematic analysis will be used for qualitative data analyses.
2. Implementation phase (Year I and II): A. Quantitative analysis: All quantitative data collected as part of the study will be identified with this number. Data on the computer will be password protected and can only be accessed by a study staff with a login and password. Before the release/sharing of data, all phases of data collection, design, analysis, storage, confidentiality, and dissemination will be evaluated for quality by study co-investigators.
Statistical analysis data will be analyzed at the individual (patient) level using multiple statistical programs including STATA/SE 15.1 software, SPSS and R package, etc.

The sociodemographic data will be presented in frequency, percentages, mean and standard deviations depending upon the categorical and continuous nature of data.
The mean HbA1c levels at the end of the 12-month intervention period will be compared between the intervention and usual care groups using generalized linear mixed models with a random cluster effect and adjusting for important baseline confounders.
Analyses will follow an intention-to-treat approach including all clusters and participants in the group they are randomized too, regardless of whether they receive or complete the intervention.
Analyses of secondary outcomes will compare the proportion of participants who are adherent to lifestyle change (such as achieved moderate or vigorous physical activity, quit the smoking, healthy diet, health care utilization, medication adherence, improved diabetes distress levels) at the end of the 12-month intervention period between the two intervention and usual care groups using generalized linear mixed models with a random cluster effect and adjusting for potential confounders.
Variables proposed to interact with the intervention will be tested (at p<0.05) by including a cross product of each variable by the intervention in a model together with the main effects.
Subgroup analyses will be performed if there is any statistically significant interaction with the intervention and all inferential analyses will follow clustered adjusting.
3. Planned subgroup analyses: An examination of whether any difference in outcomes between usual care and intervention arms varies by HbA1c levels.
The significance of subgroup effects will be assessed by tests of interactions of covariates and the treatment effect.
The study will have low power to detect all but the largest differences.
We will also look at differences in outcome by a subgroup of the fidelity of uptake (broadly classified as low, medium, or high).

Qualitative analysis: We will use a framework analysis in which sample of transcripts will be read and re-read by the researchers independently to develop an initial coding matrix of themes and categories. This will be discussed, refined and agreed before the remainder of the transcripts are analyzed using the agreed coding framework. RQDA software (R package for Qualitative Data Analysis) will be use for qualitative analysis.
4. Process evaluation: process evaluation will be conducted alongside the data collection points to understand the process of the trial and to understand the underlying mechanisms in relation to context, setting, the trained community health providers providing the lifestyle interventions and the peer supporters involved for self-management of diabetes. The anonymized data will be securely kept in a computed that will be protected with lockers. Only authorized individuals will have access to data. The collected qualitative data will be coded and entered in excel, RQDA as mentioned above will be used for analysis. Similarly, all the quantitative data collected will be securely stored which will be anonymized for the analysis and dissemination as mentioned above.
Data analysis will be done for (i) Context that will have map and description of the context that effects the CHWs intervention and peer support self-management of diabetes; (ii) Implementation- The fidelity and dose will be categorized which will provide information on the delivery of the intervention, how well the intervention provided and additional information on modification; (iii) Mechanism of Impact- Participation rate will be calculated in peer support group meetings and CHWs lifestyle modification sessions, number of telephone calls/messages delivered and in addition, the Focus group discussions (FGDs) and Interviews with the CHWs and peer supporters and leaders will be analysed to understand the content adequacy of intervention;, and (iv) Scale up- Qualitative and Quantitative analysis will be done on the Barriers and facilitator information that will be sought throughout at each step through the meetings with the local and national stakeholders like mentioned above.
5. Economic evaluation: An economic evaluation will be undertaken to determine the short-term and long-term cost-effectiveness of the community-based lifestyle intervention versus usual care. This evaluation will be undertaken from the perspective of the health care system. Information on all relevant resource use incurred during the intervention follow-up period will be collected and compared between the two study arms. These costs will include all the resources required to deliver the intervention and relevant health care utilization during follow-up. The cost of delivering the intervention will be determined from a number of the participating villages to ensure generalizability. The effectiveness of the intervention will be measured in terms of proportion reduction of HbA1c level and prevention of complications in both study arms, to determine the additional number of cases delayed/avoided. An incremental cost-effectiveness analysis will be undertaken to determine the cost per case of T2DM managed effectively. An incremental cost-utility analysis will also be performed to estimate the cost per quality adjusted life year (QALY) gained over the 12 months follow-up period, using data from the Nepali version of the EQ-5D 5L administered to participants at baseline and 12 months.
Sensitivity analysis will be undertaken to test the robustness of the analysis in terms of cost inputs and health outcomes, which will enable us to explore potential translation of results across a range of similar settings within Nepal and neighboring countries.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
1/09/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
28/02/2022
Date of last data collection
Anticipated
30/11/2023
Actual
28/04/2023
Sample size
Target
481
Accrual to date
Final
481
Recruitment outside Australia
Country [1] 23466 0
Nepal
State/province [1] 23466 0
Bagmati Province

Funding & Sponsors
Funding source category [1] 307880 0
Government body
Name [1] 307880 0
Japan Agency for Medical Research and Development (AMED) Japan
Country [1] 307880 0
Japan
Primary sponsor type
Government body
Name
AMED
Address
Japan Agency for Medical Research and Development (AMED)
Division of International Collaboration, Department of International Affairs
Japan, 100-0004 Tokyo, Chiyoda City, Otemachi, 1 Chome-7-1, JAPAN
Country
Japan
Secondary sponsor category [1] 308590 0
University
Name [1] 308590 0
Dhulikhel Hospital, University Teaching Hospital of Kathmandu University
Address [1] 308590 0
Dhulikhel Hospital, University Teaching Hospital of Kathmandu University
Kathmandu, Nepal
P.O. Box No. : 11008
Country [1] 308590 0
Nepal
Other collaborator category [1] 281653 0
University
Name [1] 281653 0
Tokyo Women’s Medical University, Japan
Address [1] 281653 0
Tokyo Women’s Medical University, Japan
8-1 Kawadacho, Shinjuku City, Tokyo 162-0054, Japan
Country [1] 281653 0
Japan
Other collaborator category [2] 281654 0
University
Name [2] 281654 0
CQ University, Australia
Address [2] 281654 0
CQ University Australia
Sydney Campus,
400 Kent St, Sydney NSW 2000
Country [2] 281654 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307880 0
Nepal Health Research Council
Ethics committee address [1] 307880 0
Ethics committee country [1] 307880 0
Nepal
Date submitted for ethics approval [1] 307880 0
24/02/2020
Approval date [1] 307880 0
16/03/2020
Ethics approval number [1] 307880 0
944/2019P

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108798 0
Prof Tomohiko Sugishita
Address 108798 0
Tokyo Womens Medical University,
8-1 Kawadacho, Shinjuku City, Tokyo 162-0054,
Japan
Country 108798 0
Japan
Phone 108798 0
+81333538111
Fax 108798 0
Email 108798 0
sugishita.tomohiko@twmu.ac.jp
Contact person for public queries
Name 108799 0
Lal Rawal
Address 108799 0
Central Queensland University,
Sydney Campus,
400 Kent street, Sydney, NSW, 2000
Country 108799 0
Australia
Phone 108799 0
+61422400033
Fax 108799 0
Email 108799 0
dr.lalrawal@gmail.com
Contact person for scientific queries
Name 108800 0
Lal Rawal
Address 108800 0
Central Queensland University,
Sydney Campus,
400 Kent street, Sydney, NSW, 2000
Country 108800 0
Australia
Phone 108800 0
+61422400033
Fax 108800 0
Email 108800 0
dr.lalrawal@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will develop data dictionary of the deidentified data once the data collection is completed. The data so far will be used only for this project and project related publication purposes. There has not been further discussion with funding agency about the possible availability of data for other groups/ individuals. If circumstances changes, we will update it in the systems.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCommunity-based lifestyle intervention for diabetes (Co-LID study) management rural Nepal: study protocol for a clustered randomized controlled trial.2023https://dx.doi.org/10.1186/s13063-023-07451-5
N.B. These documents automatically identified may not have been verified by the study sponsor.