MOnitoring NUtritional COnsequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Netherlands
Rijnstate Elst, Vitalys
RECRUITING
Elst
Time Frame
Start Date: 2025-01-28
Estimated Completion Date: 2040-01-28
Participants
Target number of participants: 1150
Treatments
General cohort
Women aged 18-55 years of age living with obesity (BMI =\> 30kg/m2) undergoing either surgical (RYGB, OAGB, SG) or pharmacological obesity treatment.
Birth cohort
Pregnant women aged 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)
Related Therapeutic Areas
Sponsors
Leads: Wageningen University and Research
Collaborators: Rijnstate Hospital

This content was sourced from clinicaltrials.gov