Digitally-Enabled Weight Management Program on T2DM

Study Overview
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Brief Summary
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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.

Official Title
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Assessing The Effectiveness of A Digitally Enabled Low Energy Diet on Type 2 Diabetes Management

Conditions
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Weight Change, Body, Type 2 Diabetes

Intervention / Treatment
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* Other: Option 1
* Other: Option 2
* Other: Option 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a clinical diagnosis of T2DM within the last 6 years Aged 20 - 70 years Have a BMI ≥ 27 kg/m2 HbA1c ≥ 48 mmol/mol (≥ 42mmol/mol if prescribed glucose-lowering agents) Have access to the internet and a computer, smartphone or tablet Ability to read and understand English Willing to provide individual consent Exclusion Criteria: Current insulin use More than two anti-hyperglycemic agents prescribed Recent routine HbA1c ≥ 90 mmol/mol Diagnosed with moderate or severe frailty Diagnosed eating disorder or purging Unable or unwilling to tolerate soy/milk-based meal replacements Myocardial infarction within last 6 months Recent eGFR <30 ml/min/1.73 m2 Prescribed SGLT2 inhibitor for diabetic kidney disease (DKD) or left ventricular hypertrophy (LVH) Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) Current treatment with anti-obesity drugs Learning difficulties that would prevent engagement with the program Having required hospitalization for depression or being prescribed antipsychotic drugs Known cancer Active substance misuse Contraindications to exercise Contraindications to lose weight Mental or physical incapacity that makes self-management inappropriate Pregnant, planning a pregnancy or lactating Currently undergoing palliative care Previous bariatric surgery or on waiting list for bariatric surgery (unless willing to come off waiting list) Unable to commit to long term lifestyle change Known proliferative retinopathy that has not been treated

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Energy Diet Group<br>A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program. | Other: Option 1<br>* 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))<br>Other: Option 2<br>* Partial meal replacement to achieve 900-1000 kcal/day (2 meal replacement products per day combined with one balanced meal (recipes provided))<br>Other: Option 3<br>* A real food low energy diet to achieve 800-1000 kcal/day (recipes provided)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Baseline to 12 Months | 
| Medication Usage use | Medications prescribed from baseline throughout study phases | Baseline to 12 Months |