Digitally-Enabled Weight Management Program on T2DM

November 11, 2024 updated by: Abbott Nutrition

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Middlesbrough, United Kingdom, TS3 6AL
        • Nhs Tees Valley Ccg
      • Morpeth, United Kingdom, NE61 6BL
        • Nhs Northumberland Ccg
      • Newcastle upon Tyne, United Kingdom, NE15 8NY
        • Nhs Newcastle Gateshead Ccg
      • North Shields, United Kingdom, NE29 7ST
        • Nhs North Tyneside Ccg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to 12 Months
Program Effectiveness
Time Frame: Baseline to 12 Months
Mean Weight Change
Baseline to 12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glycemic Control
Time Frame: Baseline to 12 Months
Mean HbA1c change
Baseline to 12 Months
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
Baseline to 12 Months
Medication Usage use
Time Frame: Baseline to 12 Months
Medications prescribed from baseline throughout study phases
Baseline to 12 Months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline to 12 Months
HRU Cost-Savings service, depending on data availability.
Time Frame: Baseline to 12 Months
Change in cost of overall healthcare resource utilization
Baseline to 12 Months
Quality of Life (QOL) SF-12
Time Frame: Baseline to 12 Months
Patient Reported (QOL) questionnaire
Baseline to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health Service, United Kingdom
Changing Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Maria Camprubi, PhD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HA55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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