NCT06763588

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

January 2, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

ScreenerDiet qualityObesityMetabolic bariatric surgeryWeight loss surgeryValidity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before surgery and at 6 mo after surgery

Secondary Outcomes (2)

  • Macro- and micronutrient intake

    Before surgery and at 6 mo after surgery

  • Dietary intake at 3 and 5 years post-surgery

    3 y and 5 y after surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Approved for (primary) bariatric surgery
  • Aged 18-65 years
  • Following the standard care pathway

You may not qualify if:

  • Previous bariatric procedure other than adjustable gastric banding
  • Non-Dutch eating pattern
  • Active eating disorders
  • Inability to fill in questionnaires or food records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitalys/Rijnstate

Elst, Gelderland, 6662 NC, Netherlands

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

October 1, 2018

Primary Completion

June 10, 2020

Study Completion

October 2, 2024

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations