RecruitingNCT06945016

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

Sponsor

Wageningen University and Research

Enrollment

1,150 participants

Start Date

Jan 28, 2025

Study Type

OBSERVATIONAL

Conditions

Body Composition Bariatric Surgery Pregnancy Muscle Strength Mental Health Nutritional Status Obesity and Obesity-related Medical Conditions Reproductive Health Anti-obesity Agents

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

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria10

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.
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).

Exclusion Criteria13

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.
Aged \<18 or \>45 years of age
\>25 weeks of gestation
Multiple pregnancy
Reversal of the bariatric procedure