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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Nutritional Status; Body Composition; Mental Health; Muscle Strength; Bariatric Surgery; Reproductive Health; Obesity and Obesity-related Medical Conditions; Anti-obesity Agents

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 Type: Observational
• Enrollment (Estimated): 1150

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Elst, Gelderland, Netherlands, 6662 NC
      • Recruiting
      • Rijnstate Elst, Vitalys
      • Contact: Laura Heusschen, PhD; Phone Number: +31628527800; Email: lheusschen@rijnstate.nl
      • Contact: Email: lheusschen@rijnstate.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed at 2 months, 1 year and 4 years post-partum.
Sleep time	Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Irritable bowel syndrome related complaints	Assessed with the Rome VI criteria.	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.
Food intolerances	Assessed with the quality of alimentation questionnaire.	Assessed at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation.
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.	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.	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.
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.	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.	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.	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.
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).	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.	Assessed in the birth cohort during first, second and third trimester.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome composition	Assessed in by extracting DNA from collected stool samples.	Assessed at baseline, and at 3 months, 6 months 1 year, 2 years, 3 years, and 5 years post surgery or pharmacological treatment initiation. In the birth cohort additionally at birth an 2 months post-partum in both mother and child.
Nutritional composition of human milk	The macro and micronutrient content of human milk samples.	Assessed at 2 months post-partum in the birth cohort.
Urinary serotonine	Assessed in spot urine samples. The second urine of the day is collected.	Assessed at baseline, and at 6 months, 1 year, 2 years, 3 years, and 5 years post surgery or pharmacological treatment initiation. In the birth cohort additionally during first and second trimester and 2 months post-partum.
Height	Height measured in cm with a stadiometer.	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. Additionally in the birth cohort during first, second, and third trimester.
Waist circumference	Measured in cm at the midpoint between the top of the hip bone and bottom of the rib cage with a non-elastic tape measure. Average of two measurements is used.	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.
Hip circumference	Measured in cm at the height of the greater trochanter with a non-elastic tape measure. Average of two measurements is used.	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.
Weight	Weight measured in kg with calibrated scales.	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. Additionally in the birth cohort during first, second, and third trimester.
General information	Participants complete a general questionnaire to gather information on sociodemographic factors, medical conditions or complications, medications, smoking, alcohol consumption and drug use.	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.
General information pregnancy	Participants in the birth cohort complete a general questionnaire to gather information on sociodemographic factors, medical history, medications, smoking, alcohol consumption, drug use, and progression of the pregnancy.	Assessed during first, second and third trimester.
Fat mass	Total fat 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.
Obesity related quality of life	Assessed with a disease specific quality of life questionnaire called the OBESI-Q. The score ranges from 0 to 100 with higher scores indicating better 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 with the Centre of Epidemiological Studies Depression Scale (CES-D). The score ranges from 0 to 60 with higher scores indicating more severe depressive 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 with the Rosenberg self-esteem scale (RSE). The score ranges between 0 and 30 with higher scores indicating better 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.
Eating disorder symptoms	Assessed with the eating disorder examination questionnaire (EDE-Q).	Assessed at baseline, and at 3 months, 6 months 1 year and 2 years post surgery or pharmacological treatment initiation. The score ranges from 0 to 6 with higher scores indicating more severe symptoms.
Post-partum depression risk	Assessed with the Edinburg postnatal depression scale (EPDS). The score ranges from 0 to 30 with higher scores indicating more severe depression symptoms.	Assessed in the birth cohort at 2 months post-partum.
Proton density fraction in the liver	The proton density fat fraction of the muscle in the liver obtained through an MRI scan.	Assessed at baseline, and at 6 months, 2 years, 4 years post surgery or pharmacological treatment initiation.

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: Rijnstate Hospital
• Investigators: Principal Investigator: Agnes Berendsen, PhD, Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): January 28, 2040
• Study Completion (Estimated): January 28, 2040

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: obesity; nutrition; Bariatric surgery; obesity treatment; body composition; cohort; observational; anti-obesity agents
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: NL86647.091.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No