NCT06945016Recruiting
Monitoring Nutritional Consequences of Obesity Treatment on Women's Health
MOnitoring NUtritional COnsequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study
Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1150 (estimated)
- First submitted
- 12 Feb 2025
- Start date
- 28 Jan 2025
- Primary completion date
- 28 Jan 2040
- Lead sponsor
- Wageningen University and Research
- Diseases
- Obesity
- NCT number
- NCT06945016
What you commit to
- Study type: Observational
- Planned participants: 1150
- From 28 Jan 2025 to the primary completion date, 28 Jan 2040
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rijnstate Elst, Vitalys Coordinator of this site? Confirm its status | Elst | Netherlands | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.