Investigating the long-term health effects of obesity treatments on women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rijnstate Elst, Vitalys
  Elst, Gelderland, Netherlands Recruiting

Study contacts

• Principal investigator: Agnes Berendsen, PhD — Wageningen University and Research

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.