Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
217 participants
OBSERVATIONAL
2022-09-30
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Low Energy Diet Group
A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
70 Years
ALL
No
Sponsors
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Changing Health
UNKNOWN
National Health Service, United Kingdom
OTHER_GOV
Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Camprubi, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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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, , United Kingdom
Countries
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Other Identifiers
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HA55
Identifier Type: -
Identifier Source: org_study_id
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