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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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A study to determine the effectiveness of two weight loss maintenance interventions in Counterweight Plus, a structured weight management programme.
Introduction: Long-term maintenance of non-surgical weight loss remains the most significant problem in obesity treatment. This study will compare the effectiveness of two different weight loss maintenance strategies used as part of the Counterweight Plus weight management programme. This study will also evaluate the behavioural impact of the Counterweight Plus interventions and include process evaluations and cost analysis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous energy restriction | Active Comparator | 1 x formula food (202-209kcal) meal replacement per day |
|
| Intermittent energy restriction | Experimental | 4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous energy restriction | Dietary Supplement | 1 x formula food (202-209kcal) meal replacement per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Difference between the two groups in change in body weight (kg) | Baseline, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Change in body weight (kg) | Baseline, 52 weeks, 78 weeks |
| Acceptability | Number of clinic appointments attended as a proportion of the total number offered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lean, FRCPS | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Lothian | Edinburgh | United Kingdom | ||||
| NHS Greater Glasgow and Clyde |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40934815 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Intermittent energy restriction | Dietary Supplement | 4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week |
|
| Baseline, 26 weeks, 52 weeks, 78 weeks |
| Behavioural strategies | Number of times behaviour change strategies used, assessed by qualitative analysis/coding of consultations | 78 weeks |
| Eating behaviours | Change measured using Three Factor Eating Questionnaire- R18 (TFEQ-R18) | Baseline, 26 weeks, 52 weeks, 78 weeks |
| Quality of life | Change measured using EuroQoL-5D (EQ-5D) | Baseline, 26 weeks, 52 weeks, 78 weeks |
| Cost of interventions | Difference between groups | 78 weeks |
| Glasgow |
| United Kingdom |
| NHS Highland | Inverness | United Kingdom |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |