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| Name | Class |
|---|---|
| Changing Health | UNKNOWN |
| National Health Service, United Kingdom | OTHER_GOV |
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The study (known as clinical audit in UK) will observe and report on a digitally-enabled structured weight management program including use of a meal replacement on clinical and economic outcomes for community-dwelling adults living with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Energy Diet Group | A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Option 1 | Other | Partial meal replacement to achieve 900-1000 kcal/day (4 meal replacement products per day combined with 150-200 kcal from vegetable meals (recipes provided)) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Program Feasibility | Participant and HCP completed program questionnaire scored from 0 to 10 where higher score is more favorable | Baseline to 12 Months |
| Program Effectiveness | Mean Weight Change | Baseline to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Mean HbA1c change | Baseline to 12 Months |
| Diabetes Distress | Participant completed PAID5 (Problem Areas In Diabetes) diabetes-related emotional distress scale from 0 to 100 where higher rating is less favorable |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Resource Utilization (HRU), including unplanned (non-study-related) (re)hospitalizations, emergency department (ED) visits, and outpatient clinic visits, depending on data | Number of unplanned inpatient hospitalizations, outpatient clinic visits, emergency department visits | Baseline to 12 Months |
| HRU Cost-Savings service, depending on data availability. |
Inclusion Criteria:
Exclusion Criteria:
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Community-dwelling adults - In partnership with North East and North Cumbria NHS Integrated Care System (ICS) we will engage with the four integrated care providers (ICP) and their Primary Care Networks (PCNs) across this system to identify and receive eligible referrals for participation in this program
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| Name | Affiliation | Role |
|---|---|---|
| Maria Camprubi, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nhs Tees Valley Ccg | Middlesbrough | TS3 6AL | United Kingdom | |||
| Nhs Northumberland Ccg |
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| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
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| Option 2 | Other | Partial meal replacement to achieve 900-1000 kcal/day (2 meal replacement products per day combined with one balanced meal (recipes provided)) |
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| Option 3 | Other | A real food low energy diet to achieve 800-1000 kcal/day (recipes provided) |
|
| Baseline to 12 Months |
| Medication Usage use | Medications prescribed from baseline throughout study phases | Baseline to 12 Months |
Change in cost of overall healthcare resource utilization |
| Baseline to 12 Months |
| Quality of Life (QOL) SF-12 | Patient Reported (QOL) questionnaire | Baseline to 12 Months |
| Morpeth |
| NE61 6BL |
| United Kingdom |
| Nhs Newcastle Gateshead Ccg | Newcastle upon Tyne | NE15 8NY | United Kingdom |
| Nhs North Tyneside Ccg | North Shields | NE29 7ST | United Kingdom |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |