Type 2 Diabetes, Weight Change, Body
Conditions
Brief summary
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.
Interventions
OTHEROption 1
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))
OTHEROption 2
Partial meal replacement to achieve 900-1000 kcal/day (2 meal replacement products per day combined with one balanced meal (recipes provided))
OTHEROption 3
A real food low energy diet to achieve 800-1000 kcal/day (recipes provided)
Sponsors
Changing Health
National Health Service, United Kingdom
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Have a clinical diagnosis of T2DM within the last 6 years 2. Aged 20 - 70 years 3. Have a BMI ≥ 27 kg/m2 4. HbA1c ≥ 48 mmol/mol (≥ 42mmol/mol if prescribed glucose-lowering agents) 5. Have access to the internet and a computer, smartphone or tablet 6. Ability to read and understand English 7. Willing to provide individual consent
Exclusion criteria
1. Current insulin use 2. More than two anti-hyperglycemic agents prescribed 3. Recent routine HbA1c ≥ 90 mmol/mol 4. Diagnosed with moderate or severe frailty 5. Diagnosed eating disorder or purging 6. Unable or unwilling to tolerate soy/milk-based meal replacements 7. Myocardial infarction within last 6 months 8. Recent eGFR \<30 ml/min/1.73 m2 9. Prescribed SGLT2 inhibitor for diabetic kidney disease (DKD) or left ventricular hypertrophy (LVH) 10. Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) 11. Current treatment with anti-obesity drugs 12. Learning difficulties that would prevent engagement with the program 13. Having required hospitalization for depression or being prescribed antipsychotic drugs 14. Known cancer 15. Active substance misuse 16. Contraindications to exercise 17. Contraindications to lose weight 18. Mental or physical incapacity that makes self-management inappropriate 19. Pregnant, planning a pregnancy or lactating 20. Currently undergoing palliative care 21. Previous bariatric surgery or on waiting list for bariatric surgery (unless willing to come off waiting list) 22. Unable to commit to long term lifestyle change 23. Known proliferative retinopathy that has not been treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Feasibility | Baseline to 12 Months | Participant and HCP completed program questionnaire scored from 0 to 10 where higher score is more favorable |
| Program Effectiveness | Baseline to 12 Months | Mean Weight Change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress | Baseline to 12 Months | Participant completed PAID5 (Problem Areas In Diabetes) diabetes-related emotional distress scale from 0 to 100 where higher rating is less favorable |
| Glycemic Control | Baseline to 12 Months | Mean HbA1c change |
| Medication Usage use | Baseline to 12 Months | Medications prescribed from baseline throughout study phases |
Other
| Measure | Time frame | Description |
|---|---|---|
| HRU Cost-Savings service, depending on data availability. | Baseline to 12 Months | Change in cost of overall healthcare resource utilization |
| Quality of Life (QOL) SF-12 | Baseline to 12 Months | Patient Reported (QOL) questionnaire |
| Healthcare Resource Utilization (HRU), including unplanned (non-study-related) (re)hospitalizations, emergency department (ED) visits, and outpatient clinic visits, depending on data | Baseline to 12 Months | Number of unplanned inpatient hospitalizations, outpatient clinic visits, emergency department visits |
Countries
United Kingdom
Outcome results
None listed