Obesity and OverweightNCT06763588
Diet Quality Before and After Metabolic Bariatric Surgery (Eetscore Study)
An observational study of Obesity and Overweight and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The aim of this study was to learn more about the use of a short screener for diet quality (Eetscore FFQ) in bariatric patients and about changes in diet quality before and after the bariatric procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity and Overweight, Bariatric Surgery, Nutrition Assessment
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2018to 2 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe obesity who were eligible and scheduled for metabolic bariatric surgery at Vitalys Obesity Clinic, part of Rijnstate hospital (Arnhem, the Netherlands), were asked to participate in this prospective cohort study. Participants were included approximately 6 weeks pre-surgery and followed up until 5 years post-surgery.
Who may be able to join
- Approved for (primary) bariatric surgery
- Aged 18-65 years
- Following the standard care pathway
Who cannot join
- Previous bariatric procedure other than adjustable gastric banding
- Non-Dutch eating pattern
- Active eating disorders
- Inability to fill in questionnaires or food records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Diet Quality After Bariatric Surgery Measured With the 'Eetscore' Screener.
The aim of this study was to learn more about the use of a short screener for diet quality (Eetscore FFQ) in bariatric patients and about changes in diet quality before and after the bariatric procedure.
- Keywords
- Screener, Diet quality, Obesity, Metabolic bariatric surgery, Weight loss surgery, Validity
- Medical subject headings
- Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
Dutch Healthy Diet index score
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.
Measured: Before surgery and at 6 mo after surgery
Secondary outcomes (2)
Macro- and micronutrient intake
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.
Measured: Before surgery and at 6 mo after surgery
Dietary intake at 3 and 5 years post-surgery
Dutch Healthy Diet index score + micro- and macronutrient intake.
Measured: 3 y and 5 y after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Oct 2018
- Primary completion10 Jun 2020
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University & Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763588
- Sponsor's protocol ID
- 2018-1214
- Status last verified
- Apr 2025
- First submitted
- 2 Jan 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37964680Heusschen 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 Oct;25(10):2731-2741. doi: 10.1017/S1368980022001501. Epub 2022 Jul 4.
PubMed 35786490
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Diet Quality After Bariatric Surgery Measured With the 'Eetscore' Screener.
- ClinicalTrials.gov ID
- NCT06763588
- Acronym / sponsor ID
- 2018-1214
- Keywords
- Screener, Diet quality, Obesity, Metabolic bariatric surgery, Weight loss surgery, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Wageningen University & Research
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to learn more about the use of a short screener for diet quality (Eetscore FFQ) in bariatric patients and about changes in diet quality before and after the bariatric procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe obesity who were eligible and scheduled for metabolic bariatric surgery at Vitalys Obesity Clinic, part of Rijnstate hospital (Arnhem, the Netherlands), were asked to participate in this prospective cohort study. Participants were included approximately 6 weeks pre-surgery and followed up until 5 years post-surgery.
Key inclusion criteria (3 listed)
- Approved for (primary) bariatric surgery
- Aged 18-65 years
- Following the standard care pathway
Key exclusion criteria (4 listed)
- Previous bariatric procedure other than adjustable gastric banding
- Non-Dutch eating pattern
- Active eating disorders
- Inability to fill in questionnaires or food records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dutch Healthy Diet index score
Time frame: Before surgery and at 6 mo after surgery
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.
2 secondary outcomes
Macro- and micronutrient intake
Time frame: Before surgery and at 6 mo after surgery
Dietary intake at 3 and 5 years post-surgery
Time frame: 3 y and 5 y after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Results publication: PubMed 37964680Heusschen 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.
- Results publication: PubMed 35786490Heusschen 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 Oct;25(10):2731-2741. doi: 10.1017/S1368980022001501. Epub 2022 Jul 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dutch Healthy Diet index score (time frame: Before surgery and at 6 mo after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06763588, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.