Monitoring Nutritional Consequences of Obesity Treatment on Women's Health
MONUCO
MOnitoring NUtritional COnsequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study
1 other identifier
observational
1,150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2025
CompletedFirst Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
April 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 28, 2040
July 10, 2025
April 1, 2025
15 years
February 12, 2025
July 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (25)
Body composition analysis
The analysis of body composition parameters using bioelectrical impedance analysis (BIA). Raw BIA parameters such as reactance, resistance and phase angle as well as derived parameters including fat-free mass, fat mass and total body water are recorded.
Assessed at baseline, and at 3 months, 6 months 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation. In the birth cohort it is additionally assessed at 1 year post-partum.
Handgrip strength
Maximal handgrip strength out of three repetitions with both the dominant and non-dominant hand.
Assessed at baseline, and at 3 months, 6 months 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation. In the birth cohort it is additionally assessed at 1 year post-partum.
Timed Chair-stand-test/Five Times Sit to Stand test
The time in seconds it takes a participant to stand-up from a seated position and sit-down 5 times without using their hands.
Assessed at baseline, and at 3 months, 6 months 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation. In the birth cohort it is additionally assessed at 1 year post-partum.
Bone mineral density
Total body and hip bone mineral density measured with a DEXA scan.
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation.
Lean mass
Total lean mass and appendicular lean mass assessed with a DEXA scan.
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation.
Peak torque of knee extensors and flexors
The maximum of 5 repetitions at a constant angle speeds of 60 degrees per second in an isokinetic dynamometer.
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation.
Total work of knee extensors and flexors
The work accomplished during 15 repetitions at 180 degrees/second in a isokinetic dynamometer.
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation.
Bone formation
P1NP (Total procollagen type 1-teriminal propeptide) measured in a venous blood sample.
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation. In the birth cohort additionally during first and third trimester and at 1 year post-partum.
Bone resorption
CTX (type-1 collagen) measured in a venous blood sample.
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation. In the birth cohort additionally during first and third trimester and at 1 year post-partum.
Proton density fraction in the bone marrow
The proton density fat fraction of the bone marrow obtained through an MRI scan.
Assessed at baseline, and at 6 months, 2 years, 4 years post surgery or pharmacological treatment initiation.
Proton density fraction in the muscles of the thigh and back
The proton density fat fraction of the muscle in the low back and upper thigh obtained through an MRI scan.
Assessed at baseline, and at 6 months, 2 years, 4 years post surgery or pharmacological treatment initiation.
Habitual dietary intake
Assessed through a food-frequency questionnaire.
Assessed at baseline, and 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation.
Actual dietary intake
Assessed with the TRAQQ app, a mobile phone application that performs 9 2 -h recalls on 3 days.
At 3 months and 6 months post surgery or pharmacological treatment initiation. In the birth cohort additionally during first and third trimester and at 2 months post-partum.
Nutrient status
Presence of nutrient deficiencies.
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation. In the birth cohort during first, second and third trimester and at 2 months and 1 year post-partum.
Neonatal birth weight
Neonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.
Directly after birth
Calcaneal Speed of Sound
Speed of Sound in measured in the calcaneus with a quantitative ultrasound machine.
Assessed during first trimester, third trimester and 1 year post-partum.
Calcaneal Broadband Ultrasound Attenuation
Broadband ultrasound attenuation in measured in the calcaneus with a quantitative ultrasound machine.
Assessed during first trimester, third trimester and 1 year post-partum.
Diet quality
Assessed through the Eetscore, a brief food-frequency questionnaire.
Assessed in the birth cohort during the second trimester and at 1 years and 4 years post-partum.
Neonatal nutrient status
Presence of nutrient deficiencies measured in cord blood collected after birth.
Assessed in the birth cohort at birth.
Fetal growth: biparietal diameter
Biparietal diameter measured during prenatal ultrasounds.
Assessed in first trimester, second trimester and third trimester.
Fetal growth: abdominal circumference
Abdominal circumference measured during the prenatal ultrasounds.
Assessed in first trimester, second trimester and third trimester.
Fetal growth: femur length
Femur length measured during the prenatal ultrasounds.
Assessed in first trimester, second trimester and third trimester.
Fetal growth: head circumference
Head circumference measured during the prenatal ultrasounds.
Assessed in first trimester, second trimester and third trimester.
Fetal growth: frontal occipital diameter
Frontal occipital diameter measured during the prenatal ultrasounds.
Assessed in first trimester, second trimester and third trimester.
Estimated fetal weight
Estimated based on prenatal ultrasounds.
Assessed in first trimester, second trimester and third trimester.
Secondary Outcomes (20)
General information on child growth and development
Assessed at 2 months, 1 year and 4 years post-partum.
Sleep quality
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation. In the birth cohort it is assessed during second trimester and at 1 year post-partum.
Physical activity
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation. In the birth cohort it is assessed during second trimester and at 1 year post-partum.
Sleep time
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation.
Energy expenditure (kcals)
Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years post surgery or pharmacological treatment initiation.
- +15 more secondary outcomes
Other Outcomes (16)
Obesity related quality of life
Assessed at baseline, and at 3 months, 6 months 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation.
Depression symptoms
Assessed at baseline, and at 3 months, 6 months 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation.
Self-esteem
Assessed at baseline, and at 3 months, 6 months 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation.
- +13 more other outcomes
Study Arms (2)
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)
Eligibility Criteria
The study population of the MONUCO study consists of women undergoing either surgical or pharmacological obesity treatment. Participants who become pregnant during the general cohort will be asked to participate within the birth cohort. Additionally, all other women with a history of obesity treatment and who are pregnant are eligible to participate in the birth cohort as well. Patient recruitment will start at Vitalys, a clinic for obesity treatment, part of Rijnstate hospital, with locations in Arnhem/Elst and Ede (Ziekenhuis Gelderse Vallei). Recruitment will be expanded to other high-volume obesity centres in the Netherlands.
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen University and Researchlead
- Rijnstate Hospitalcollaborator
Study Sites (1)
Rijnstate Elst, Vitalys
Elst, Gelderland, 6662 NC, Netherlands
Biospecimen
The following samples will be retained: urine, stool, venous blood (serum, plasma and full blood), cord blood and breastmilk.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Agnes Berendsen, PhD
Wageningen University and Research
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 12, 2025
First Posted
April 25, 2025
Study Start
January 28, 2025
Primary Completion (Estimated)
January 28, 2040
Study Completion (Estimated)
January 28, 2040
Last Updated
July 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
In due time, we plan to share all IPD that underlie results in a publication. However, as we have just started recruitment, no specific plans have been made yet. Once this is clear, we will update this registration.