MOnitoring NUtritional COnsequences of Obesity Treatment on women*s health and transgenerational effects for healthier future generations.

Conditions: Muscle qualtiy
bone mineral density
10025477
10047635
10028393

Registration Number: NL-OMON56975

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 1150

Inclusion Criteria

Inclusion criteria for the cohort:
- Female at birth
- Aged 18-55 years of age
- Living with obesity (BMI => 30kg/m^2)
- Approved for obesity treatment in one of the participating hospitals.
- Undergoing bariatric surgery (RYGB OAGB, or SG)
- Receiving obesity medication (any type) under medical supervision with
BMI => 30kg/m^2)
- 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 criteria for the (integrated) birth cohort:
- Being pregnant, or having pregnancy wish
- Age 18-45 years of age
- Having received prior obesity treatment (either surgical (RYGB, SG) or
pharmacological, at least 4 months)

Exclusion Criteria

Exclusion criteria for the cohort:
- Male sex at birth
- Aged <18 or >55 years of age
- BMI <30 kg/m^2
- Not able to read and/or write 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.

Additional criteria for the (integrated) birth cohort:
- Aged <18 or >45 years of age
- >25 weeks of gestation
- Multiple pregnancy
- Reversal of the bariatric procedure

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main parameters are changes in nutrient intake and status as well as muscle<br /><br>mass and bone mineral density. Muscle strength, muscle fat infiltration and<br /><br>bone marrow adipose tissue are main outcomes of the subgroup. Main endpoints of<br /><br>the birth cohort are foetal growth and child development. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are lifestyle factors and parameters of the endocrine and<br /><br>reproductive systems (i.e., menstrual complaints, thyroid function and hormonal<br /><br>changes).</p><br>