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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05483140
Other study ID # HA55
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 26, 2022
Est. completion date September 2024

Study information

Verified date January 2024
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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Study Design


Intervention

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

Locations

Country Name City State
United Kingdom Nhs Tees Valley Ccg Middlesbrough
United Kingdom Nhs Northumberland Ccg Morpeth
United Kingdom Nhs Newcastle Gateshead Ccg Newcastle upon Tyne
United Kingdom Nhs North Tyneside Ccg North Shields

Sponsors (3)

Lead Sponsor Collaborator
Abbott Nutrition Changing Health, National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other HRU Cost-Savings service, depending on data availability. Change in cost of overall healthcare resource utilization Baseline to 12 Months
Other Quality of Life (QOL) SF-12 Patient Reported (QOL) questionnaire Baseline to 12 Months
Primary Program Feasibility Participant and HCP completed program questionnaire scored from 0 to 10 where higher score is more favorable Baseline to 12 Months
Primary Program Effectiveness Mean Weight Change Baseline to 12 Months
Secondary Glycemic Control Mean HbA1c change Baseline to 12 Months
Secondary 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
Secondary Medication Usage use Medications prescribed from baseline throughout study phases Baseline to 12 Months
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