Status:
RECRUITING
Monitoring Nutritional Consequences of Obesity Treatment on Women's Health
Lead Sponsor:
Wageningen University and Research
Collaborating Sponsors:
Rijnstate Hospital
Conditions:
Obesity and Obesity-related Medical Conditions
Bariatric Surgery
Eligibility:
FEMALE
18-55 years
Brief Summary
The goal of this observational study is to investigate the long-term effect of obesity treatments on the health of women. This study will specifically focusses on the effects on nutritional intake, nu...
Detailed Description
The MONUCO study is a multicenter 10-year prospective observational cohort study with an integrated birth cohort. Women between the ages of 18-55 years approved for either surgical or pharmacological ...
Eligibility Criteria
Inclusion
- General
- Female sex at birth
- Aged 18-55 years of age
- Living with obesity (BMI ≥ 30 kg/m2)
- Approved for obesity treatment in one of the participating hospitals:
- Undergoing primary bariatric surgery (RYGB, OAGB or SG)
- Receiving obesity medication (any type) with a BMI ≥30 kg/m2 under medical supervision.
- For those undergoing MRI, DEXA and quantitative ultrasound scan: Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician.
- Additional inclusion criteria for birth cohort:
- Being pregnant
- Age 18-45 years of age
- Having received prior obesity treatment, either surgical (RYGB, OAGB, SG) or pharmacological for at least 4 months under medical supervision (any type).
- General
Exclusion
- Male sex at birth
- Aged \<18 or \>55 years of age
- BMI \<30 kg/m2
- Not able to read and/or write in Dutch
- Undergoing a revisional or secondary bariatric procedure (excluding previous gastric banding)
- Malnutrition due to other chronic condition, specifically malignancy, substance abuse
- (mental) condition that makes it impossible to fill out a questionnaire correctly.
- For those undergoing a DEXA scan: height \>196 cm or weight \>160 kg
- For those undergoing a MRI scan: having a contra-indication to MRI scanning including (but not limited to) pacemakers and defibrillators, intraorbital or intraocular metallic fragments, ferromagnetic implans or claustrophobia.
- Additional exclusion criteria birth cohort:
- Aged \<18 or \>45 years of age
- \>25 weeks of gestation
- Multiple pregnancy
- Reversal of the bariatric procedure
Key Trial Info
Start Date :
January 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 28 2040
Estimated Enrollment :
1150 Patients enrolled
Trial Details
Trial ID
NCT06945016
Start Date
January 28 2025
End Date
January 28 2040
Last Update
July 10 2025
Active Locations (1)
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1
Rijnstate Elst, Vitalys
Elst, Gelderland, Netherlands, 6662 NC