Digitally-Enabled Weight Management Program on T2DM

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes; Weight Change, Body
• Intervention / Treatment: Other: Option 1; Other: Option 2; Other: Option 3

• Study Type: Observational
• Enrollment (Actual): 217

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesbrough, United Kingdom, TS3 6AL
    • Nhs Tees Valley Ccg
  • Morpeth, United Kingdom, NE61 6BL
    • Nhs Northumberland Ccg
  • Newcastle upon Tyne, United Kingdom, NE15 8NY
    • Nhs Newcastle Gateshead Ccg
  • North Shields, United Kingdom, NE29 7ST
    • Nhs North Tyneside Ccg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Low Energy Diet Group; A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program.

Other: Option 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)); Other: Option 2; Partial meal replacement to achieve 900-1000 kcal/day (2 meal replacement products per day combined with one balanced meal (recipes provided)); Other: Option 3; A real food low energy diet to achieve 800-1000 kcal/day (recipes provided)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Collaborators: National Health Service, United Kingdom; Changing Health
• Investigators: Study Chair: Maria Camprubi, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Diabetes Mellitus, Type 2; Body Weight Changes
• Other Study ID Numbers: HA55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No