NCT06945016 Monitoring Nutritional Consequences of Obesity Treatment on Women's Health
| NCT ID | NCT06945016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wageningen University and Research |
| Condition | Obesity and Obesity-related Medical Conditions |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,150 participants |
| Start Date | 2025-01-28 |
| Primary Completion | 2040-01-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,150 participants in total. It began in 2025-01-28 with a primary completion date of 2040-01-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, nutritional status, musculoskeletal health and reproductive health. Additionally, this study will also investigate the effect of obesity treatment on pregnancy outcomes and child development. To achieve the goal of this study, participants already receiving either surgical treatment for obesity or treatment with anti-obesity medication as part of their regular medical care will fill in additional questionnaires, provide blood, urine and feces samples, and undergo additional measurements of body composition and muscle strength up to for 10 years.
Eligibility Criteria
General Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Agnes Berendsen, PhD
PRINCIPAL INVESTIGATOR
Wageningen University and Research
Frequently Asked Questions
Who can join the NCT06945016 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Obesity and Obesity-related Medical Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06945016 currently recruiting?
Yes, NCT06945016 is actively recruiting participants. Visit ClinicalTrials.gov or contact Wageningen University and Research to inquire about joining.
Where is the NCT06945016 trial being conducted?
This trial is being conducted at Elst, Netherlands.
Who is sponsoring the NCT06945016 clinical trial?
NCT06945016 is sponsored by Wageningen University and Research. The principal investigator is Agnes Berendsen, PhD at Wageningen University and Research. The trial plans to enroll 1,150 participants.
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