Digitally-Enabled Weight Management Program on T2DM

NCT05483140 | Completed

• 1 other identifier: HA55
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 4

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.

Conditions

Weight Change, Body; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Glycemic Control

  Baseline to 12 Months

• Diabetes Distress

  Baseline to 12 Months

• Medication Usage use

  Baseline to 12 Months

Other Outcomes (3)

• 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

• HRU Cost-Savings service, depending on data availability.

  Baseline to 12 Months

• Quality of Life (QOL) SF-12

  Baseline to 12 Months

Study Arms (1)

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; Other: Option 2; Other: Option 3

Interventions

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))

Low Energy Diet Group

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))

Low Energy Diet Group

Option 3 OTHER

A real food low energy diet to achieve 800-1000 kcal/day (recipes provided)

Low Energy Diet Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead
• Changing Health: collaborator
• National Health Service, United Kingdom: collaborator

Study Sites (4)

Nhs Tees Valley Ccg

Middlesbrough, TS3 6AL, United Kingdom

Location

Nhs Northumberland Ccg

Morpeth, NE61 6BL, United Kingdom

Location

Nhs Newcastle Gateshead Ccg

Newcastle upon Tyne, NE15 8NY, United Kingdom

Location

Nhs North Tyneside Ccg

North Shields, NE29 7ST, United Kingdom

Location

MeSH Terms

Conditions

Body Weight Changes; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Maria Camprubi, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 1, 2022
• Study Start: September 30, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)