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OpenTrials
Completed

NCT Number: NCT05483140

Digitally-Enabled Weight Management Program on T2DM

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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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nhs Tees Valley Ccg, Middlesbrough, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Contraindications to exercise
  • Contraindications to lose weight
  • Mental or physical incapacity that makes self-management inappropriate
  • Pregnant, planning a pregnancy or lactating
  • Currently undergoing palliative care
  • Previous bariatric surgery or on waiting list for bariatric surgery (unless willing to come off waiting list)
  • Unable to commit to long term lifestyle change
  • Known proliferative retinopathy that has not been treated

Treatment and study plan

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))

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))

Option 3

Other

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

Primary outcomes

  1. Program Feasibility

    Time frame: Baseline to 12 Months

    Participant and HCP completed program questionnaire scored from 0 to 10 where higher score is more favorable

  2. Program Effectiveness

    Time frame: Baseline to 12 Months

    Mean Weight Change

Secondary outcomes

  1. Glycemic Control

    Time frame: Baseline to 12 Months

    Mean HbA1c change

  2. Diabetes Distress

    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

  3. Medication Usage use

    Time frame: Baseline to 12 Months

    Medications prescribed from baseline throughout study phases

Other outcomes

  1. Healthcare Resource Utilization (HRU), including unplanned (non-study-related) (re)hospitalizations, emergency department (ED) visits, and outpatient clinic visits, depending on data

    Time frame: Baseline to 12 Months

    Number of unplanned inpatient hospitalizations, outpatient clinic visits, emergency department visits

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

    Time frame: Baseline to 12 Months

    Change in cost of overall healthcare resource utilization

  3. Quality of Life (QOL) SF-12

    Time frame: Baseline to 12 Months

    Patient Reported (QOL) questionnaire

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Collaborators

  • Changing Health
  • National Health Service, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2022
Registry last updated
Nov 12, 2024

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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