Diet, Food, and NutritionPhase 1SixtyPLUSNCT06059404
Tailoring OT and RD Services for Home-delivered Meal Clients
A Phase 1 study testing Meals + RD services only, Meals + OT services only and Meals + RD + OT services in people with Diet, Food, and Nutrition and Accidental Fall, run by Ohio State University at 1 site in United States.
Trial summary
This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diet, Food, and Nutrition, Accidental Fall, Diabetes Mellitus
- What is being tested?
- Meals + RD services only, Meals + OT services only and Meals + RD + OT services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 31 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported diagnosis of cardiovascular disease (cardiovascular disease may include: hypertension, high cholesterol, congestive heart failure, heart attack or myocardial infarction, peripheral artery disease, stent placement, coronary artery disease, coronary artery bypass graft) or diabetes
- Over 60 years of age
- Has one of the following fall risk factors: Uses an assistive mobility device (cane, walker, or wheelchair); Has a fear of falling; Has fallen in the past 12 months; Feels unsteady when standing or walking;
- Able to store 14 frozen meals/week;
- Able to reheat meals
Who cannot join
- Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within past 6-months)
- Individuals residing in residential care or a skilled nursing facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Pilot Randomized Controlled Trial (SixtyPLUS)
This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Participants will be randomized into one of four study arms: In Arm 1: clients will receive home-delivered meals and basic nutrition education and fall prevention education. In Arm 2: clients will receive home-delivered meals plus dietitian services. In Arm 3: clients will receive home-delivered meals plus occupational therapy services. In Arm 4: clients will receive home-delivered meals plus dietitian and occupational therapy services. Outcomes will be assessed at baseline and at 3-month follow-up.
Read the detailed description
Participants will be randomized into one of four study arms: ARM 1 - Meals only: Participants randomized to receive "meals only" will receive 14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 40 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention education via standard handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be "heart healthy" as well as "diabetic-friendly." Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards. ARM 2 - Meals + registered dietitian services: Participants randomized to receive "meals + RD only" will receive 14 frozen meals, delivered 1x/week, for 3-months. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will have a telephone-based nutrition assessment completed by one of LifeCare Alliance's registered dietitians who will assign participants a nutrition diagnosis (e.g., overconsumption of carbohydrates) within 60 days of study enrollment. During the same phone call, the registered dietitian will also assist participants with their initial meal selections and encourage participants to contact the dietitian with follow-up questions or concerns via phone. Participants will be able to make weekly meal selections based on an approved menu of meals tailored (by a dietitian) to the health needs of the participant. Additionally, dietitians will initiate at least one follow-up phone call no later than 45 days after the nutrition assessment is completed. ARM 3 - Meals + occupational therapy services: Participants randomized to this arm will receive 14 frozen meals, delivered 1x/week, for 3-months and be able to make weekly meal selections from LifeCare Alliance's full list of 40 meals. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will be contacted (within 30 days of study enrollment) by one of Lifecare Alliance's occupational therapists to complete a phone screen to determine each participant's occupational therapy needs (e.g., home safety/fall risk hazards, need for durable medical equipment). Within 30 days after the phone screen, the occupational therapist will then complete an in-home assessment with the participant and provide any initial interventions, equipment, exercises, education as indicated. Within 45 days of the in-home assessment/treatment encounter, the OT will complete an in-home OR phone-based (at the OT's discretion) follow-up session to determine participants' adherence to fall prevention recommendations. All participants randomized to this arm will also be encouraged to call the occupational therapist with questions or concerns over the 3-month study period. ARM 4 - Meals + registered dietitian services + occupational therapy services: Participants in this arm will receive 14 frozen meals, delivered 1x/week, for 3-months as well as the same nutrition education and fall prevention handouts as provided in Arms 1-3. Additionally, participants will receive the combination of dietitian and OT services as provided in Arms 2 and 3 and have the same autonomy to make their own weekly meal selections from a curated list provided by the dietitian.
- Being tested
- Meals + RD services only, Meals + OT services only, Meals + RD + OT services
- Medical subject headings
- Diabetes Mellitus, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meals + RD services onlyBehavioural
Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education
Meals + OT services onlyBehavioural
Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies
Meals + RD + OT servicesBehavioural
A combination of tailored registered dietitian and occupational therapy services will be provided
| Study group | Role | What they receive |
|---|---|---|
| Meals only | No intervention | ARM 1: Meals only. Participants randomized to receive "meals only" will receive 14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 40 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be "heart healthy" as well as "diabetic-friendly." Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards. |
| Meals + registered dietitian services | Active comparator | ARM 2: Meals + registered dietitian services. Participants randomized to receive "meals + RD only" will receive 14 frozen meals, delivered 1x/week, for 3-months. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will have a telephone-based nutrition assessment completed by one of LifeCare Alliance's registered dietitians who will assign participants a nutrition diagnosis (e.g., overconsumption of carbohydrates) within 60 days of study enrollment. Receives: Behavioral: Meals + RD services only |
| Meals + occupational therapy services | Active comparator | ARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 14 frozen meals, delivered 1x/week, for 3-months and be able to make weekly meal selections from LifeCare Alliance's full list of 40 meals. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will be contacted (within 30 days of study enrollment) by one of Lifecare Alliance's occupational therapists to complete a phone screen to determine each participant's occupational therapy needs (e.g., home safety/fall risk hazards, need for durable medical equipment). Receives: Behavioral: Meals + OT services only |
| Meals + registered dietitian + occupational therapy services | Experimental | ARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 14 frozen meals, delivered 1x/week, for 3-months as well as the same nutrition education and fall prevention handouts as provided in Arms 1-3. Additionally, participants will receive the combination of dietitian and OT services as provided in Arms 2 and 3 and have the same autonomy to make their own weekly meal selections from a curated list provided by the dietitian. Receives: Behavioral: Meals + RD + OT services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Nutritional Assessment-Short Form
Determine level of malnutrition status
Measured: Baseline and 3-months
Secondary outcomes (2)
Summary of Diabetes Self-Care Activities Measure
Assess management of diabetes as well as heart disease
Measured: Baseline and 3-months
Falls efficacy scale
Assess concerns with falling during daily activities
Measured: Baseline and 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Sep 2023
- Primary completion29 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diet, Food, and NutritionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- LifeCare Alliance
- Responsible party
- Principal investigator, Lisa Juckett, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059404
- Sponsor's protocol ID
- 2023H0248
- Acronym
- SixtyPLUS
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Study protocol for a randomized, parallel-group trial to compare the effectiveness of registered dietitian and occupational therapy services on fall risk among home-delivered meal recipients. BMC Geriatr. 2026 Apr 16;26(1):749. doi: 10.1186/s12877-026-07376-z.
PubMed 41992111Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Sathya TS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Occupational therapy and registered dietitian services to reduce fall risk among home delivered meal clients: a randomized controlled feasibility trial. BMC Geriatr. 2025 May 10;25(1):325. doi: 10.1186/s12877-025-06008-2.
PubMed 40348980Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Sathya TS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Tailoring registered dietitian and occupational therapy services for home-delivered meal recipients: feasibility study protocol for a randomized controlled trial. Pilot Feasibility Stud. 2025 Apr 5;11(1):41. doi: 10.1186/s40814-025-01623-7.
PubMed 40188322
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Pilot Randomized Controlled Trial (SixtyPLUS)
- ClinicalTrials.gov ID
- NCT06059404
- Acronym / sponsor ID
- SixtyPLUS / 2023H0248
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- LifeCare Alliance
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Participants will be randomized into one of four study arms: In Arm 1: clients will receive home-delivered meals and basic nutrition education and fall prevention education. In Arm 2: clients will receive home-delivered meals plus dietitian services. In Arm 3: clients will receive home-delivered meals plus occupational therapy services. In Arm 4: clients will receive home-delivered meals plus dietitian and occupational therapy services. Outcomes will be assessed at baseline and at 3-month follow-up.
Detailed description
Participants will be randomized into one of four study arms: ARM 1 - Meals only: Participants randomized to receive "meals only" will receive 14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 40 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention education via standard handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be "heart healthy" as well as "diabetic-friendly." Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards. ARM 2 - Meals + registered dietitian services: Participants randomized to receive "meals + RD only" will receive 14 frozen meals, delivered 1x/week, for 3-months. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will have a telephone-based nutrition assessment completed by one of LifeCare Alliance's registered dietitians who will assign participants a nutrition diagnosis (e.g., overconsumption of carbohydrates) within 60 days of study enrollment. During the same phone call, the registered dietitian will also assist participants with their initial meal selections and encourage participants to contact the dietitian with follow-up questions or concerns via phone. Participants will be able to make weekly meal selections based on an approved menu of meals tailored (by a dietitian) to the health needs of the participant. Additionally, dietitians will initiate at least one follow-up phone call no later than 45 days after the nutrition assessment is completed. ARM 3 - Meals + occupational therapy services: Participants randomized to this arm will receive 14 frozen meals, delivered 1x/week, for 3-months and be able to make weekly meal selections from LifeCare Alliance's full list of 40 meals. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will be contacted (within 30 days of study enrollment) by one of Lifecare Alliance's occupational therapists to complete a phone screen to determine each participant's occupational therapy needs (e.g., home safety/fall risk hazards, need for durable medical equipment). Within 30 days after the phone screen, the occupational therapist will then complete an in-home assessment with the participant and provide any initial interventions, equipment, exercises, education as indicated. Within 45 days of the in-home assessment/treatment encounter, the OT will complete an in-home OR phone-based (at the OT's discretion) follow-up session to determine participants' adherence to fall prevention recommendations. All participants randomized to this arm will also be encouraged to call the occupational therapist with questions or concerns over the 3-month study period. ARM 4 - Meals + registered dietitian services + occupational therapy services: Participants in this arm will receive 14 frozen meals, delivered 1x/week, for 3-months as well as the same nutrition education and fall prevention handouts as provided in Arms 1-3. Additionally, participants will receive the combination of dietitian and OT services as provided in Arms 2 and 3 and have the same autonomy to make their own weekly meal selections from a curated list provided by the dietitian.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Meals only | No intervention | –ARM 1: Meals only. Participants randomized to receive "meals only" will receive 14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 40 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be "heart healthy" as well as "diabetic-friendly." Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards. |
| Meals + registered dietitian services | Active comparator | Behavioral: Meals + RD services onlyARM 2: Meals + registered dietitian services. Participants randomized to receive "meals + RD only" will receive 14 frozen meals, delivered 1x/week, for 3-months. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will have a telephone-based nutrition assessment completed by one of LifeCare Alliance's registered dietitians who will assign participants a nutrition diagnosis (e.g., overconsumption of carbohydrates) within 60 days of study enrollment. |
| Meals + occupational therapy services | Active comparator | Behavioral: Meals + OT services onlyARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 14 frozen meals, delivered 1x/week, for 3-months and be able to make weekly meal selections from LifeCare Alliance's full list of 40 meals. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will be contacted (within 30 days of study enrollment) by one of Lifecare Alliance's occupational therapists to complete a phone screen to determine each participant's occupational therapy needs (e.g., home safety/fall risk hazards, need for durable medical equipment). |
| Meals + registered dietitian + occupational therapy services | Experimental | Behavioral: Meals + RD + OT servicesARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 14 frozen meals, delivered 1x/week, for 3-months as well as the same nutrition education and fall prevention handouts as provided in Arms 1-3. Additionally, participants will receive the combination of dietitian and OT services as provided in Arms 2 and 3 and have the same autonomy to make their own weekly meal selections from a curated list provided by the dietitian. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported diagnosis of cardiovascular disease (cardiovascular disease may include: hypertension, high cholesterol, congestive heart failure, heart attack or myocardial infarction, peripheral artery disease, stent placement, coronary artery disease, coronary artery bypass graft) or diabetes
- Over 60 years of age
- Has one of the following fall risk factors: Uses an assistive mobility device (cane, walker, or wheelchair); Has a fear of falling; Has fallen in the past 12 months; Feels unsteady when standing or walking;
- Able to store 14 frozen meals/week;
- Able to reheat meals
Key exclusion criteria (2 listed)
- Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within past 6-months)
- Individuals residing in residential care or a skilled nursing facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meals + RD services onlyRegistered dietitians (RD) will provide tailored dietitian counseling and nutrition education | Behavioural | Meals + registered dietitian services |
| Meals + OT services onlyOccupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies | Behavioural | Meals + occupational therapy services |
| Meals + RD + OT servicesA combination of tailored registered dietitian and occupational therapy services will be provided | Behavioural | Meals + registered dietitian + occupational therapy services |
Primary outcome
Mini Nutritional Assessment-Short Form
Time frame: Baseline and 3-months
Determine level of malnutrition status
2 secondary outcomes
Summary of Diabetes Self-Care Activities Measure
Time frame: Baseline and 3-months
Falls efficacy scale
Time frame: Baseline and 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 41992111Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Study protocol for a randomized, parallel-group trial to compare the effectiveness of registered dietitian and occupational therapy services on fall risk among home-delivered meal recipients. BMC Geriatr. 2026 Apr 16;26(1):749. doi: 10.1186/s12877-026-07376-z.
- Derived from this study: PubMed 40348980Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Sathya TS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Occupational therapy and registered dietitian services to reduce fall risk among home delivered meal clients: a randomized controlled feasibility trial. BMC Geriatr. 2025 May 10;25(1):325. doi: 10.1186/s12877-025-06008-2.
- Derived from this study: PubMed 40188322Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Sathya TS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Tailoring registered dietitian and occupational therapy services for home-delivered meal recipients: feasibility study protocol for a randomized controlled trial. Pilot Feasibility Stud. 2025 Apr 5;11(1):41. doi: 10.1186/s40814-025-01623-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meals + RD services only, Meals + OT services only and Meals + RD + OT services in people with Diet, Food, and Nutrition and Accidental Fall, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Nutritional Assessment-Short Form (time frame: Baseline and 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059404, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.