Monitoring Nutritional Consequences of Obesity Treatment on Women's Health
Recruiting · NCT06945016 · Observational (researchers observe without assigning treatment) · Lead sponsor: Wageningen University and Research
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Rijnstate Elst, Vitalys - Elst, Gelderland, Netherlands