Investigating the long-term health effects of obesity treatments on women
MOnitoring NUtritional COnsequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study
This study is trying to see how different obesity treatments affect women's health over time, including their nutrition, bones, muscles, and pregnancy outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Wageningen University and Research Academic / other |
| Locations | 1 site (Elst, Gelderland) |
| Trial ID | NCT06945016 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the long-term impacts of obesity treatments on women's health, focusing on nutritional intake, nutritional status, musculoskeletal health, and reproductive health. Participants, aged 18-55 and approved for obesity treatment, will provide data through questionnaires, blood, urine, and feces samples, and undergo body composition and muscle strength measurements over a period of up to 10 years. The study also includes an integrated birth cohort to assess pregnancy outcomes and child development in women who become pregnant during the follow-up.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-55 with a BMI of 30 kg/m2 or higher who are approved for either surgical or pharmacological obesity treatment.
Not a fit: Patients who are male, under 18 or over 55 years of age, or have a BMI below 30 kg/m2 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how obesity treatments affect women's health and inform better care strategies.
How similar studies have performed: While there have been studies on obesity treatments, this specific long-term observational approach focusing on women's health outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Elst, Gelderland
- Rijnstate Elst, Vitalys — Elst, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Agnes Berendsen, PhD — Wageningen University and Research
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.