Obesity and Obesity-related Medical ConditionsMONUCONCT06945016
Monitoring Nutritional Consequences of Obesity Treatment on Women's Health
An observational study of Obesity and Obesity-related Medical Conditions and Bariatric Surgery, run by Wageningen University and Research at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Bariatric Surgery, Anti-obesity Agents
- How many people
- 1,150 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jan 2025to 28 Jan 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
General Inclusion Criteria:
- 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).
General Exclusion Criteria:
- 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.
Additional exclusion criteria birth cohort:
- Aged <18 or >45 years of age
- >25 weeks of gestation
- Multiple pregnancy
- Reversal of the bariatric procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Rijnstate Elst, Vitalys
Elst, Gelderland, 6662 NC
Laura Heusschen, PhD, +31628527800, lheusschen@rijnstate.nl
lheusschen@rijnstate.nl
About this study
Official title: MOnitoring NUtritional COnsequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study
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.
Read the detailed description
The MONUCO study is a multicenter 10-year prospective observational cohort study with an integrated birth cohort. Women between the ages of 18-55 years approved for either surgical or pharmacological obesity treatment at one of the participating centers are invited. Follow-up data will be collected at 6-weeks pre-treatment, three months, six months and one year up to ten years post-surgery. At each time point, participants fill in questionnaires on lifestyle factors, gastrointestinal complaints, menstrual and postmenopausal complaints, and mental health. They also record their dietary intake using FFQ's and a 2h-recall method via the Traqq application. Additionally, they provide blood, urine and feces samples which are stored at -80 degrees Celsius for future analysis. During a study visit at each time point, height, weight, hip and waist circumference is measured as well as body composition with BIA and muscle strength and balance with handgrip strength and a timed chair-stand test. In a subgroup of the study population, a DEXA scan and/or MRI scan is performed and physical activity is tracked with an accelerometer.
Women who become pregnant during the follow-up period will be included in the integrated birth cohort. To supplement this number, pregnant women who have had obesity treatment who are not a part of the overall cohort are also invited. Within the integrated birth cohort, measurements are collected at each trimester during pregnancy and two months post-partum, six months post-partum, after one year up to four years after pregnancy. During pregnancy, the participant fill in questionnaire on lifestyle factors, gastrointestinal complaints and pregnancy-related complaints as well as record dietary intake with an FFQ and 2h-recall method. In this group also provides blood, urine, stool and human milk samples.
- Conditions
- Obesity and Obesity-related Medical Conditions, Bariatric Surgery, Anti-obesity Agents, Body Composition, Muscle Strength, Reproductive Health
- Keywords
- cohort, obesity treatment, obesity, Bariatric surgery, anti-obesity agents, body composition, nutrition, observational
- Medical subject headings
- Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Directly after birth
Calcaneal Speed of Sound
Speed of Sound in measured in the calcaneus with a quantitative ultrasound machine.
Measured: 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.
Measured: Assessed during first trimester, third trimester and 1 year post-partum.
Diet quality
Assessed through the Eetscore, a brief food-frequency questionnaire.
Measured: 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.
Measured: Assessed in the birth cohort at birth.
Fetal growth: biparietal diameter
Biparietal diameter measured during prenatal ultrasounds.
Measured: Assessed in first trimester, second trimester and third trimester.
Fetal growth: abdominal circumference
Abdominal circumference measured during the prenatal ultrasounds.
Measured: Assessed in first trimester, second trimester and third trimester.
Fetal growth: femur length
Femur length measured during the prenatal ultrasounds.
Measured: Assessed in first trimester, second trimester and third trimester.
Fetal growth: head circumference
Head circumference measured during the prenatal ultrasounds.
Measured: Assessed in first trimester, second trimester and third trimester.
Fetal growth: frontal occipital diameter
Frontal occipital diameter measured during the prenatal ultrasounds.
Measured: Assessed in first trimester, second trimester and third trimester.
Estimated fetal weight
Estimated based on prenatal ultrasounds.
Measured: Assessed in first trimester, second trimester and third trimester.
Secondary outcomes (20)
General information on child growth and development
Participants in the birth cohort will fill in a general questionnaire with questions about body length, height and weight as well as other developmental aspects.
Measured: Assessed at 2 months, 1 year and 4 years post-partum.
Sleep quality
Assessed using the Pitsburg Sleep Quality Index (PSQI). The minimum and maximum values of this index are 0 and 21 respectively. Higher scores indicate poorer sleep quality.
Measured: 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 using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). The results can be expressed as minutes per week spend on physical activity or a metabolic equivalent task (MET) score. A higher MET score indicates more intense physical activity. The minimum MET score is 1. There is no official upper limit of the MET score.
Measured: 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
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Measured: 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)
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Measured: 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.
Steps
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Measured: 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.
Metabolic Equivalent of Task (MET) rate
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Measured: 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 sedentary time
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Measured: 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 time doing light physical activity
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Measured: 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 time doing moderate physical activity
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Measured: 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 time doing vigorous physical activity
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Measured: 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.
Menstrual complaints
Assessed using a custom made questionnaire containing questions about menstrual history, dysmenorrhoea, menstrual complaints, bleeding and choice of contraceptives.
Measured: 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 at 1 year post-partum.
Menopausal complaints
Assessed using a custom made questionnaire containing questions menopausal complaints and the use of hormones.
Measured: 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 at 1 year post-partum.
Gastrointestinal complaints
Assessed with the gastrointestinal symptom rating scale (GSRS). The minimum score is 15 and the maximum score is 105. Higher score indicate worse gastrointestinal symptoms.
Measured: 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 assessed during the second trimester.
Irritable bowel syndrome related complaints
Assessed with the Rome VI criteria.
Measured: 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 assessed during the second trimester.
Early dumping syndrome complaints
Assessed with the Sigstad score. The mimimum and maximum values of the score are -5 and 25 respectively. Scores greater or equal to 7 indicate that dumping syndrome is likely. Higher scores indicates more and more severe dumping syndrome symptoms.
Measured: Assessed at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation. In the birth cohort it is assessed during the first and third trimester.
Dumping syndrome complaints
Assessed with the Arts dumping score questionnaire. The minimum and maximum score of the score are 0 and 26 respectively. Higher scores indicate more severe dumping syndrome symptoms.
Measured: Assessed at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation. In the birth cohort it is assessed during the first and third trimester.
Food intolerances
Assessed with the quality of alimentation questionnaire.
Measured: Assessed at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation.
Stool pattern
Assessed with the Bristol stool chart. The chart indicates the form and consistency of the stool with 7 distinct types. From hard lumps (type 1) to watery stools (type 7).
Measured: 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 assessed during the second trimester.
Pregnancy related symptomes
Assessed with the pregnancy symptoms inventory (PSI). This inventory include two subscales. The Frequency of Pregnancy Symptoms score ranges from 0 to 126, and the Limitation of Daily Activities score ranges from 42 to 126. Higher scores indicate more frequent symptoms and more severe limitation of daily activities.
Measured: Assessed in the birth cohort during first, second and third trimester.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start28 Jan 2025
- Primary completion28 Jan 2040 (estimated)
- Study completion28 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Principal investigator, Agnes Berendsen, Wageningen University and Research
- Investigators
- Agnes Berendsen, PhD, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945016
- Sponsor's protocol ID
- NL86647.091.24
- Acronym
- MONUCO
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Schipper RM, Heusschen L, Schepers L, Verstraete FF, Hazebroek EJ, Kampman E, Berendsen AAM. Monitoring nutritional consequences of obesity treatment on long-term health of women and their offspring: protocol of a multicentre prospective cohort study. BMJ Open. 2026 Sep 18;16(9):e119119. doi: 10.1136/bmjopen-2026-119119.
PubMed 42760085
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOnitoring NUtritional COnsequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06945016
- Acronym / sponsor ID
- MONUCO / NL86647.091.24
- Conditions
- Obesity and Obesity-related Medical Conditions, Bariatric Surgery, Anti-obesity Agents, Body Composition, Muscle Strength, Reproductive Health
- Keywords
- cohort, obesity treatment, obesity, Bariatric surgery, anti-obesity agents, body composition, nutrition, observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 28 Jan 2040 (estimated)
- Study completion
- 28 Jan 2040 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The MONUCO study is a multicenter 10-year prospective observational cohort study with an integrated birth cohort. Women between the ages of 18-55 years approved for either surgical or pharmacological obesity treatment at one of the participating centers are invited. Follow-up data will be collected at 6-weeks pre-treatment, three months, six months and one year up to ten years post-surgery. At each time point, participants fill in questionnaires on lifestyle factors, gastrointestinal complaints, menstrual and postmenopausal complaints, and mental health. They also record their dietary intake using FFQ's and a 2h-recall method via the Traqq application. Additionally, they provide blood, urine and feces samples which are stored at -80 degrees Celsius for future analysis. During a study visit at each time point, height, weight, hip and waist circumference is measured as well as body composition with BIA and muscle strength and balance with handgrip strength and a timed chair-stand test. In a subgroup of the study population, a DEXA scan and/or MRI scan is performed and physical activity is tracked with an accelerometer.
Women who become pregnant during the follow-up period will be included in the integrated birth cohort. To supplement this number, pregnant women who have had obesity treatment who are not a part of the overall cohort are also invited. Within the integrated birth cohort, measurements are collected at each trimester during pregnancy and two months post-partum, six months post-partum, after one year up to four years after pregnancy. During pregnancy, the participant fill in questionnaire on lifestyle factors, gastrointestinal complaints and pregnancy-related complaints as well as record dietary intake with an FFQ and 2h-recall method. In this group also provides blood, urine, stool and human milk samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body composition analysis
Time frame: 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.
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.
Handgrip strength
Time frame: 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.
Maximal handgrip strength out of three repetitions with both the dominant and non-dominant hand.
Timed Chair-stand-test/Five Times Sit to Stand test
Time frame: 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.
The time in seconds it takes a participant to stand-up from a seated position and sit-down 5 times without using their hands.
Bone mineral density
Time frame: 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 body and hip bone mineral density measured with a DEXA scan.
Lean mass
Time frame: 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 lean mass and appendicular lean mass assessed with a DEXA scan.
Peak torque of knee extensors and flexors
Time frame: 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.
The maximum of 5 repetitions at a constant angle speeds of 60 degrees per second in an isokinetic dynamometer.
Total work of knee extensors and flexors
Time frame: 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.
The work accomplished during 15 repetitions at 180 degrees/second in a isokinetic dynamometer.
Bone formation
Time frame: 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.
P1NP (Total procollagen type 1-teriminal propeptide) measured in a venous blood sample.
Bone resorption
Time frame: 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.
CTX (type-1 collagen) measured in a venous blood sample.
Proton density fraction in the bone marrow
Time frame: Assessed at baseline, and at 6 months, 2 years, 4 years post surgery or pharmacological treatment initiation.
The proton density fat fraction of the bone marrow obtained through an MRI scan.
Proton density fraction in the muscles of the thigh and back
Time frame: Assessed at baseline, and at 6 months, 2 years, 4 years post surgery or pharmacological treatment initiation.
The proton density fat fraction of the muscle in the low back and upper thigh obtained through an MRI scan.
Habitual dietary intake
Time frame: Assessed at baseline, and 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation.
Assessed through a food-frequency questionnaire.
Actual dietary intake
Time frame: 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.
Assessed with the TRAQQ app, a mobile phone application that performs 9 2 -h recalls on 3 days.
Nutrient status
Time frame: 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.
Presence of nutrient deficiencies.
Neonatal birth weight
Time frame: Directly after birth
Neonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.
Calcaneal Speed of Sound
Time frame: Assessed during first trimester, third trimester and 1 year post-partum.
Speed of Sound in measured in the calcaneus with a quantitative ultrasound machine.
Calcaneal Broadband Ultrasound Attenuation
Time frame: Assessed during first trimester, third trimester and 1 year post-partum.
Broadband ultrasound attenuation in measured in the calcaneus with a quantitative ultrasound machine.
Diet quality
Time frame: Assessed in the birth cohort during the second trimester and at 1 years and 4 years post-partum.
Assessed through the Eetscore, a brief food-frequency questionnaire.
Neonatal nutrient status
Time frame: Assessed in the birth cohort at birth.
Presence of nutrient deficiencies measured in cord blood collected after birth.
Fetal growth: biparietal diameter
Time frame: Assessed in first trimester, second trimester and third trimester.
Biparietal diameter measured during prenatal ultrasounds.
Fetal growth: abdominal circumference
Time frame: Assessed in first trimester, second trimester and third trimester.
Abdominal circumference measured during the prenatal ultrasounds.
Fetal growth: femur length
Time frame: Assessed in first trimester, second trimester and third trimester.
Femur length measured during the prenatal ultrasounds.
Fetal growth: head circumference
Time frame: Assessed in first trimester, second trimester and third trimester.
Head circumference measured during the prenatal ultrasounds.
Fetal growth: frontal occipital diameter
Time frame: Assessed in first trimester, second trimester and third trimester.
Frontal occipital diameter measured during the prenatal ultrasounds.
Estimated fetal weight
Time frame: Assessed in first trimester, second trimester and third trimester.
Estimated based on prenatal ultrasounds.
20 secondary outcomes
General information on child growth and development
Time frame: Assessed at 2 months, 1 year and 4 years post-partum.
Sleep quality
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Steps
Time frame: 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.
Metabolic Equivalent of Task (MET) rate
Time frame: 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 sedentary time
Time frame: 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 time doing light physical activity
Time frame: 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 time doing moderate physical activity
Time frame: 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 time doing vigorous physical activity
Time frame: 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.
Menstrual complaints
Time frame: 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 at 1 year post-partum.
Menopausal complaints
Time frame: 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 at 1 year post-partum.
Gastrointestinal complaints
Time frame: 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 assessed during the second trimester.
Irritable bowel syndrome related complaints
Time frame: 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 assessed during the second trimester.
Early dumping syndrome complaints
Time frame: Assessed at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation. In the birth cohort it is assessed during the first and third trimester.
Dumping syndrome complaints
Time frame: Assessed at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation. In the birth cohort it is assessed during the first and third trimester.
Food intolerances
Time frame: Assessed at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation.
Stool pattern
Time frame: 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 assessed during the second trimester.
Pregnancy related symptomes
Time frame: Assessed in the birth cohort during first, second and third trimester.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 42760085Schipper RM, Heusschen L, Schepers L, Verstraete FF, Hazebroek EJ, Kampman E, Berendsen AAM. Monitoring nutritional consequences of obesity treatment on long-term health of women and their offspring: protocol of a multicentre prospective cohort study. BMJ Open. 2026 Sep 18;16(9):e119119. doi: 10.1136/bmjopen-2026-119119.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnes Berendsen, PhD principal investigator
Wageningen University and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity-related Medical Conditions and Bariatric Surgery, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition analysis (time frame: 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.). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06945016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.