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
NA
63 participants
INTERVENTIONAL
2016-04-12
2019-11-22
Brief Summary
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Detailed Description
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Methods: 80 patients and 10 practitioners will be recruited into the study. Main inclusion criteria for patients are:
Completed Counterweight Plus, which includes 12-20 weeks total diet replacement (TDR), 8 weeks food reintroduction (FR) and achieved \>10kg weight loss. All participants will be followed up for 18 months in total.
Results: The primary outcome of this study is the difference in weight change between the two groups at 6 months. Frequency of use of behavioural strategy will be quantified for both practitioners and patients during voice recorded consultations. The relationship between weight change and the use of behavioural strategy will be assessed.
Hypothesis: This study will establish if the novel intermittent use of formula diet strategy is more effective at preventing weight regain in comparison to usual care. It will also provide evidence of the frequency of use of behavioural strategies within routine Counterweight Plus delivery, as well as establishing the cost of the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
Intermittent energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Intermittent energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Interventions
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Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
Intermittent energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
65 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Michael Lean, FRCPS
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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NHS Lothian
Edinburgh, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
NHS Highland
Inverness, , United Kingdom
Countries
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References
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Brosnahan N, Hankey C, Leeds A, Leslie W, Thom G, Hutchison L, Govan L, Ross H, Lean MEJ. Diet strategies for maintaining substantial therapeutic weight loss: 78-week mixed methods randomised trial. Clin Nutr. 2025 Oct;53:188-198. doi: 10.1016/j.clnu.2025.08.009. Epub 2025 Aug 12.
Other Identifiers
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GN15HN592
Identifier Type: -
Identifier Source: org_study_id
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