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| Name | Class |
|---|---|
| University of Barcelona | OTHER |
| Clinica Dorsia | UNKNOWN |
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All participants were weighed every week for 24 weeks, wearing light clothes to the nearest 0.1 kg, using a body composition analyzer. Height was determined during the first clinic evaluation using a fixed wall stadiometer to the nearest 0.1 cm, in standing position.
Intervention: Participants followed a liquid diet plan during the first week after the endoscopic bariatric procedure (Bioenterics Intragastric Balloon - BIB - or Primary Obesity Surgery Endoluminal - POSE -). Subsequently, subjects were randomly assigned either a Mediterranean-style or a protein diet plan. Energy intake was calculated according to the Spanish Consensus on Bariatric Endoscopy.
The hypothesis of this project is to analyze whether the Mediterranean-style diet is more effective compared with the open protein diet plans in weight loss and weight relapse in subjects with obesity who underwent endoscopic bariatric therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean-style diet plan | Mediterranean-style diet plan (6 months): 22% proteins, 53% carbohydrates, and 25% of lipids. 52 participants. |
| |
| Open protein diet plan | Open protein presents (6 months) 40% of proteins, 29% carbohydrate and 31% of lipids. 26 participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet plan | Dietary Supplement | Mediterranean style is a non-restricted diet plan compared with the open protein diet plan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weekly weight loss | Every week up to 24 weeks | |
| Weight relapse after 36 weeks | 1 time after 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic. Patients of Dorsia Clinics Surgery and Aesthetic Medicine
By email: antonio.egea@upc.edu
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 25, 2020 | Jan 29, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |