Weight Change, BodyNCT05483140
Digitally-Enabled Weight Management Program on T2DM
An observational study of Weight Change, Body and Type 2 Diabetes, run by Abbott Nutrition at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Weight Change, Body, Type 2 Diabetes
- What is being tested?
- Option 1, Option 2 and Option 3
- How many people
- 217 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 30 Sep 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Nhs Tees Valley Ccg
Middlesbrough, TS3 6AL
Nhs Northumberland Ccg
Morpeth, NE61 6BL
Nhs Newcastle Gateshead Ccg
Newcastle upon Tyne, NE15 8NY
Nhs North Tyneside Ccg
North Shields, NE29 7ST
About this study
Official title: 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.
- Conditions
- Weight Change, Body, Type 2 Diabetes
- Being tested
- Option 1, Option 2, Option 3
- Medical subject headings
- Body Weight Changes, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Option 1Other
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 2Other
Partial meal replacement to achieve 900-1000 kcal/day (2 meal replacement products per day combined with one balanced meal (recipes provided))
Option 3Other
A real food low energy diet to achieve 800-1000 kcal/day (recipes provided)
| Study group | Role | What they receive |
|---|---|---|
| Low Energy Diet Group | A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program. Receives: Other: Option 1; Other: Option 2; Other: Option 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Feasibility
Participant and HCP completed program questionnaire scored from 0 to 10 where higher score is more favorable
Measured: Baseline to 12 Months
Program Effectiveness
Mean Weight Change
Measured: Baseline to 12 Months
Secondary outcomes (3)
Glycemic Control
Mean HbA1c change
Measured: Baseline to 12 Months
Diabetes Distress
Participant completed PAID5 (Problem Areas In Diabetes) diabetes-related emotional distress scale from 0 to 100 where higher rating is less favorable
Measured: Baseline to 12 Months
Medication Usage use
Medications prescribed from baseline throughout study phases
Measured: Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start30 Sep 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changing Health, National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Maria Camprubi, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483140
- Sponsor's protocol ID
- HA55
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing The Effectiveness of A Digitally Enabled Low Energy Diet on Type 2 Diabetes Management
- ClinicalTrials.gov ID
- NCT05483140
- Acronym / sponsor ID
- HA55
- Conditions
- Weight Change, Body, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Changing Health, National Health Service, United Kingdom
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Energy Diet Group | – | Other: Option 1, Other: Option 2, Other: Option 3A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Option 1Partial 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 | Low Energy Diet Group |
| Option 2Partial meal replacement to achieve 900-1000 kcal/day (2 meal replacement products per day combined with one balanced meal (recipes provided)) | Other | Low Energy Diet Group |
| Option 3A real food low energy diet to achieve 800-1000 kcal/day (recipes provided) | Other | Low Energy Diet Group |
Primary outcome
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
Program Effectiveness
Time frame: Baseline to 12 Months
Mean Weight Change
3 secondary outcomes
Glycemic Control
Time frame: Baseline to 12 Months
Diabetes Distress
Time frame: Baseline to 12 Months
Medication Usage use
Time frame: Baseline to 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Camprubi, PhD study chair
Abbott Nutrition
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Change, Body and Type 2 Diabetes, run by Abbott Nutrition at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Feasibility (time frame: Baseline to 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.