- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06763588
Diet Quality Before and After Metabolic Bariatric Surgery (Eetscore Study)
Changes in Diet Quality After Bariatric Surgery Measured With the 'Eetscore' Screener.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gelderland
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Elst, Gelderland, Netherlands, 6662 NC
- Vitalys/Rijnstate
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Approved for (primary) bariatric surgery
- Aged 18-65 years
- Following the standard care pathway
Exclusion Criteria:
- Previous bariatric procedure other than adjustable gastric banding
- Non-Dutch eating pattern
- Active eating disorders
- Inability to fill in questionnaires or food records
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dutch Healthy Diet index score
Time Frame: Before surgery and at 6 mo after surgery
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The DHD2015-index consists of fifteen components representing the Dutch food-based dietary guidelines of 2015: vegetables, fruit, wholegrain products, legumes, nuts, dairy, fish, tea, fats and oils, coffee, red meat, processed meat, sweetened beverages, alcohol and Na. Additionally, the component 'unhealthy food choices' was added based on the guideline of the Netherlands Nutrition Centre. For every component, the score ranges from 0 (no adherence) to 10 points (complete adherence), resulting in a total score between 0 and 160 points. Total DHD2015-index score and individual component scores were calculated from the Eetscore FFQ and 3-day food records. |
Before surgery and at 6 mo after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Macro- and micronutrient intake
Time Frame: Before surgery and at 6 mo after surgery
|
Macronutrient composition of the diet was evaluated by intake of total energy, total carbohydrates and mono- and disaccharides, total protein, plant-based and animal-based protein, total fat, saturated fat, monounsaturated fatty acids and polyunsaturated fatty acids (including alpha-linolenic acid, eicosapentaenoic acid, and docosahexaenoic acid), and dietary fibre.
Furthermore, dietary intake of a limited range of micronutrients for which bariatric patients often display low serum levels was assessed: folate, vitamin B12, vitamin D, calcium and iron.
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Before surgery and at 6 mo after surgery
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Dietary intake at 3 and 5 years post-surgery
Time Frame: 3 y and 5 y after surgery
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Dutch Healthy Diet index score + micro- and macronutrient intake.
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3 y and 5 y after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Heusschen L, Berendsen AAM, Balvers MGJ, Deden LN, de Vries JHM, Hazebroek EJ. Changes in nutrient composition and diet quality in the first 6 months following bariatric surgery: An observational cohort study. J Hum Nutr Diet. 2024 Feb;37(1):365-376. doi: 10.1111/jhn.13258. Epub 2023 Nov 14.
- Heusschen L, Berendsen AA, Balvers MG, Deden LN, de Vries JH, Hazebroek EJ. Relative validity of a short screener to assess diet quality in patients with severe obesity before and after bariatric surgery. Public Health Nutr. 2022 Jul 4;25(10):1-11. doi: 10.1017/S1368980022001501. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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