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Digitally-Enabled Weight Management Program on T2DM

Sponsor
Abbott Nutrition (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05483140
Collaborator
Changing Health (Other), National Health Service, United Kingdom (Other)
200
Enrollment
4
Locations
16
Anticipated Duration (Months)
50
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Option 1
  • Other: Option 2
  • Other: Option 3

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessing The Effectiveness of A Digitally Enabled Low Energy Diet on Type 2 Diabetes Management
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Program Feasibility [Baseline to 12 Months]

    Participant and HCP completed program questionnaire

  2. Program Effectiveness [Baseline to 12 Months]

    Mean Weight Change

Secondary Outcome Measures

  1. Glycemic Control [Baseline to 12 Months]

    Mean HbA1c change

  2. Diabetes Distress [Baseline to 12 Months]

    Participant completed PAID5 (Problem Areas In Diabetes) diabetes-related emotional distress score

  3. Medication Usage use [Baseline to 12 Months]

    Medications prescribed from baseline throughout study phases

Other Outcome Measures

  1. 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

  2. HRU Cost-Savings service, depending on data availability. [Baseline to 12 Months]

    Change in cost of overall healthcare resource utilization

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nhs Tees Valley Ccg Middlesbrough United Kingdom TS3 6AL
2 Nhs Northumberland Ccg Morpeth United Kingdom NE61 6BL
3 Nhs Newcastle Gateshead Ccg Newcastle upon Tyne United Kingdom NE15 8NY
4 Nhs North Tyneside Ccg North Shields United Kingdom NE29 7ST

Sponsors and Collaborators

  • Abbott Nutrition
  • Changing Health
  • National Health Service, United Kingdom

Investigators

  • Study Chair: Maria Camprubi, PhD, Abbott Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT05483140
Other Study ID Numbers:
  • HA55
First Posted:
Aug 1, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Body Weight Changes

Study Results

No Results Posted as of Aug 1, 2022