Evaluation of a community-led traditional food-based programme for remission of type 2 diabetes, in Nepal
| ISRCTN | ISRCTN14042582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14042582 |
| Secondary identifying numbers | GACD Prevention in Cities Reference: GACD2023-151 |
- Submission date
- 15/04/2024
- Registration date
- 14/05/2024
- Last edited
- 05/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
To provide a sustainable, very low-cost solution for the large and growing problem of type 2 diabetes in Nepal
Who can participate?
Adults aged 30-70 years who are detected to have diabetes at community screening
What does the study involve?
Consuming cheap, local, traditional foods designed to provide all essential nutrients and produce weight loss of 10-15kg over about 8 weeks, followed by an eating plan to avoid weight regain, for at least 12 months.
What are the possible benefits and risks of participating?
Benefit is the possibility of remission of type 2 diabetes, not requiring medication. No risks.
Where is the study run from?
Dhulikhel Hospital and its outreach centres, in Nepal.
When is the study starting and how long is it expected to run for?
September 2022 to September 2027
Who is funding the study?
Funded by the Medical Research Council (UK) on behalf of the Global Alliance for Chronic Diseases
Who is the main contact?
Prof Mike Lean, mike.lean@glasgow.ac.uk
Contact information
Public, Scientific, Principal Investigator
Hatton Castle
Newtyle
Blairgowrie
PH12 8UN
United Kingdom
 ORCID ID |
0000-0003-2216-0083 |
|---|---|
| Phone | +44 7720885387 |
| mike.lean@glasgow.ac.uk |
Study information
| Study design | Hybrid effectiveness and implementation study incorporating a single centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | To follow |
| Scientific title | Co-DiRECT Nepal: a community-based diet programme for remission of type 2 diabetes and amelioration of non-communicable disease risks |
| Study acronym | Co-DiRECT Nepal |
| Study objectives | The research aim is to evaluate a proven dietary intervention, for remission of type 2 diabetes (T2D) and reduction of chronic non-communicable disease (NCD) risks, culturally adapted for implementation in the context of rapidly-growing peri-urban populations in and around cities in the Kathmandu Valley of Nepal. |
| Ethics approval(s) |
1. Approved 23/10/2024, Nepal Health Research Council Ethical Review Board (Ramshah Path, Kathmandu, -, Nepal; +977-1-4254220 / +977-1-4254220; nhrc@nhrc.gov.np), ref: 810 2. Not yet submitted, University of Glasgow MVLS College Ethics Committee (College of Medicine, Veterinary & Life Sciences, School of Cardiovascular and Metabolic Health, New Lister Building, Glasgow Royal Infirmary, Glasgow, G31 2ER, United Kingdom; +44 (0)141 201 8519; terry.quinn@glasgow.gla.ac.uk), ref: 200240032 |
| Health condition(s) or problem(s) studied | Remission or amelioration of type 2 diabetes |
| Intervention | The intervention is diet plans, with support from trained community volunteers, comprising traditional, very low-cost, foods selected to provide all essential micronutrients and an energy content designed for (1) weight loss over 8-10 weeks, and then (2) weight loss maintenance up to at least 12 months. Control group is delayed intervention, after the 4-month randomised trial. Randomisation will use sealed envelopes. Outcome measures are fingerprick HbA1c at 4 months (randomised trial) and 12 months (observational). |
| Intervention type | Behavioural |
| Primary outcome measure | Glycated haemoglobin measured using fingerprick HbA1c at baseline, 4 and 12 months |
| Secondary outcome measures | 1. Body weight measured using scales at baseline, 4 and 12 months 2. Qualitative assessments of incentives and barriers to diet adherence measured using customised questionnaire during weight loss induction and maintenance phases |
| Overall study start date | 01/09/2022 |
| Completion date | 30/09/2027 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | Screen-detected HbA1c above 48 mmol/mol |
| Key exclusion criteria | 1. Known diabetes on medication 2. Non-local residents 3. Planned migration within 12 months |
| Date of first enrolment | 06/01/2025 |
| Date of final enrolment | 01/06/2025 |
Locations
Countries of recruitment
- Nepal
Study participating centre
45200
Nepal
Sponsor information
University/education
School of Medicine, New Lister Building, Royal Infirmary
Glasgow
G31 2ER
Scotland
United Kingdom
| Phone | +44 141 330 5691 |
|---|---|
| matthew.walters@glasgow.ac.uk | |
| Website | https://www.gla.ac.uk/schools/medicine/staff/mikelean/ |
"ROR" |
https://ror.org/00vtgdb53 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications in high impact peer reviewed journals, presentations and reports to governmet and professional agencies, and a documentary film for future training and public dissemination of results. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date, using methods to be defined in accordance with funder's requirements. |
Editorial Notes
05/11/2024: Ethics approval details added.
08/10/2024: The recruitment start date was changed from 01/10/2024 to 06/01/2025.
03/06/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/01/2025 to 01/10/2024.
2. The overall end date was changed from 31/05/2027 to 30/09/2027.
16/04/2024: Trial's existence confirmed by MRC.
