Digitally-Enabled Weight Management Program on T2DM

Completed

• Conditions: Weight Change, Body; Type 2 Diabetes
• Interventions: Other: Option 1; Other: Option 2; Other: Option 3

• Registration Number: NCT05483140
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-01
• Study Start: 2022-09-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low Energy Diet Group	Option 1	A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program.
Low Energy Diet Group	Option 2	A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program.
Low Energy Diet Group	Option 3	A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Glycemic Control	Baseline to 12 Months	Mean HbA1c change
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
Medication Usage use	Baseline to 12 Months	Medications prescribed from baseline throughout study phases

Trial Locations

Locations (4)

Nhs Tees Valley Ccg; 🇬🇧 Middlesbrough, United Kingdom

Nhs Newcastle Gateshead Ccg; 🇬🇧 Newcastle upon Tyne, United Kingdom

Nhs Northumberland Ccg; 🇬🇧 Morpeth, United Kingdom

Nhs North Tyneside Ccg; 🇬🇧 North Shields, United Kingdom