Actively Recruiting
Monitoring Nutritional Consequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study
Led by Wageningen University and Research · Updated on 2025-07-10
1150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wageningen University and Research
Lead Sponsor
R
Rijnstate Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the long-term effects of obesity treatments on women's health, focusing on nutritional intake, nutritional status, musculoskeletal health, and reproductive health. The study also examines how obesity treatments impact pregnancy outcomes and child development. This is a multicenter, 10-year observational study involving women aged 18 to 55 who are approved for either surgical or pharmacological obesity treatment at participating centers. Participants will be followed from 6 weeks before treatment through multiple time points up to 10 years after starting treatment. They will complete questionnaires about lifestyle, gastrointestinal and reproductive health, and mental health. They will also track dietary intake using a specialized app, and provide blood, urine, and feces samples. Physical measurements will include body composition, muscle strength, balance tests, and in some cases, DEXA and MRI scans. Physical activity will be monitored with accelerometers. Pregnant women who have had prior obesity treatment or become pregnant during the study will join an integrated birth cohort with additional assessments during pregnancy and up to four years after birth. Throughout the study, participants will have regular visits for questionnaires, sample collections, and various physical and imaging assessments at scheduled intervals. Key measurements include body composition, muscle strength, bone density, dietary intake, nutrient status, and pregnancy-related outcomes. Child growth and development will also be monitored in the birth cohort. Safety and health status will be tracked over the years, with data collected up to 10 years post-treatment to understand the long-term impact of obesity therapies on women and their children.
CONDITIONS
Brief Title
Monitoring Nutritional Consequences of Obesity Treatment on Women's Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex at birth
- Aged 18-55 years
- Living with obesity (BMI 260 30 kg/m2)
- Approved for obesity treatment at a participating hospital
- Undergoing primary bariatric surgery (RYGB, OAGB, or SG) or receiving obesity medication under medical supervision
- Willing to be informed about incidental findings if undergoing MRI, DEXA, or ultrasound scans
- For birth cohort: pregnant women aged 18-45 years
- For birth cohort: prior obesity treatment for at least 4 months under medical supervision
You will not qualify if you...
- Male sex at birth
- Younger than 18 or older than 55 years
- BMI less than 30 kg/m2
- Unable to read or write in Dutch
- Undergoing revisional or secondary bariatric procedure (except previous gastric banding)
- Malnutrition due to chronic conditions like malignancy or substance abuse
- Mental conditions preventing proper questionnaire completion
- Height over 196 cm or weight over 160 kg for DEXA scan
- Contraindications to MRI (e.g., pacemakers, metallic implants, claustrophobia)
- For birth cohort: older than 45 years, more than 25 weeks pregnant, multiple pregnancy, or reversal of bariatric procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants are observed over a long period to monitor nutritional and health outcomes following obesity treatment.
Study visits at 6 weeks pre-treatment, 3 months, 6 months, 1 year, and annually up to 10 years post-treatment initiation
Duration - From pregnancy through 4 years post-partum
Pregnant participants and those who become pregnant during follow-up are monitored throughout pregnancy and postpartum for up to 4 years to assess transgenerational health effects.
Visits each trimester during pregnancy and at 2 months, 6 months, 1 year, and annually up to 4 years post-partum
Trial Site Locations
Total: 1 location
1
Rijnstate Elst, Vitalys
Elst, Gelderland, Netherlands, 6662 NC
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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