Option 1
OtherPartial meal replacement to achieve 900-1000 kcal/day (4 meal replacement products per day combined with 150-200 kcal from vegetable meals (recipes provided))
NCT Number: NCT05483140
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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Notify Me20 year–70 year
All sexes
Observational
Nhs Tees Valley Ccg, Middlesbrough, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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))
Partial meal replacement to achieve 900-1000 kcal/day (2 meal replacement products per day combined with one balanced meal (recipes provided))
A real food low energy diet to achieve 800-1000 kcal/day (recipes provided)
Time frame: Baseline to 12 Months
Participant and HCP completed program questionnaire scored from 0 to 10 where higher score is more favorable
Time frame: Baseline to 12 Months
Mean Weight Change
Time frame: Baseline to 12 Months
Mean HbA1c change
Time frame: 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
Time frame: Baseline to 12 Months
Medications prescribed from baseline throughout study phases
Time frame: Baseline to 12 Months
Number of unplanned inpatient hospitalizations, outpatient clinic visits, emergency department visits
Time frame: Baseline to 12 Months
Change in cost of overall healthcare resource utilization
Time frame: Baseline to 12 Months
Patient Reported (QOL) questionnaire
Abbott Nutrition
Industry
Assessing The Effectiveness of A Digitally Enabled Low Energy Diet on Type 2 Diabetes Management
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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