Clinical trial NCT06945016: Monitoring Nutritional Consequences of Obesity Treatment on Women's Health
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity and Obesity-related Medical Conditions
Bariatric Surgery
Anti-obesity Agents
Body Composition
Muscle Strength
Reproductive Health
Mental Health
Pregnancy
Nutritional Status
Keywords: cohort
obesity treatment
obesity
Bariatric surgery
anti-obesity agents
body composition
nutrition
observational
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
First posted: 2025-04-25
Enrollment: 1150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body composition analysis
timeFrame: 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.
measure: Handgrip strength
timeFrame: 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.
measure: Timed Chair-stand-test/Five Times Sit to Stand test
timeFrame: 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.
measure: Bone mineral density
timeFrame: 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.
measure: Lean mass
timeFrame: 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.
measure: Peak torque of knee extensors and flexors
timeFrame: 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.
measure: Total work of knee extensors and flexors
timeFrame: 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.
measure: Bone formation
timeFrame: 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.
measure: Bone resorption
timeFrame: 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.
measure: Proton density fraction in the bone marrow
timeFrame: Assessed at baseline, and at 6 months, 2 years, 4 years post surgery or pharmacological treatment initiation.
measure: Proton density fraction in the muscles of the thigh
timeFrame: Assessed at baseline, and at 6 months, 2 years, 4 years post surgery or pharmacological treatment initiation.
measure: Habitual dietary intake
timeFrame: Assessed at baseline, and 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation.
measure: Actual dietary intake
timeFrame: 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.
measure: Nutrient status
timeFrame: 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.
measure: Neonatal birth weight
timeFrame: Directly after birth
measure: Calcaneal Speed of Sound
timeFrame: Assessed during first trimester, third trimester and 1 year post-partum.
measure: Calcaneal Broadband Ultrasound Attenuation
timeFrame: Assessed during first trimester, third trimester and 1 year post-partum.
measure: Diet quality
timeFrame: Assessed in the birth cohort during the second trimester and at 1 years and 4 years post-partum.
measure: Neonatal nutrient status
timeFrame: Assessed in the birth cohort at birth.
measure: Fetal growth: biparietal diameter
timeFrame: Assessed in first trimester, second trimester and third trimester.
measure: Fetal growth: abdominal circumference
timeFrame: Assessed in first trimester, second trimester and third trimester.
measure: Fetal growth: femur length
timeFrame: Assessed in first trimester, second trimester and third trimester.
measure: Fetal growth: head circumference
timeFrame: Assessed in first trimester, second trimester and third trimester.
measure: Fetal growth: frontal occipital diameter
timeFrame: Assessed in first trimester, second trimester and third trimester.
measure: Estimated fetal weight
timeFrame: Assessed in first trimester, second trimester and third trimester.
Secondary outcomes:
measure: General information on child growth and development
timeFrame: Assessed at 2 months, 1 year and 4 years post-partum.
measure: Sleep quality
timeFrame: 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.
measure: Physical activity
timeFrame: 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.
measure: Sleep time
timeFrame: 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.
measure: Energy expenditure (kcals)
timeFrame: 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.
measure: Steps
timeFrame: 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.
measure: Metabolic Equivalent of Task (MET) rate
timeFrame: 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.
measure: Total sedentary time
timeFrame: 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.
measure: Total time doing light physical activity
timeFrame: 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.
measure: Total time doing moderate physical activity
timeFrame: 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.
measure: Total time doing vigorous physical activity
timeFrame: 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.
measure: Menstrual complaints
timeFrame: 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.
measure: Menopausal complaints
timeFrame: 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.
measure: Gastrointestinal complaints
timeFrame: 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.
measure: Irritable bowel syndrome related complaints
timeFrame: 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.
measure: Early dumping syndrome complaints
timeFrame: 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.
measure: Dumping syndrome complaints
timeFrame: 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.
measure: Food intolerances
timeFrame: Assessed at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation.
measure: Stool pattern
timeFrame: 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.
measure: Pregnancy related symptomes
timeFrame: Assessed in the birth cohort during first, second and third trimester.
Other outcomes:
measure: Obesity related quality of life
timeFrame: 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.
measure: Depression symptoms
timeFrame: 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.
measure: Self-esteem
timeFrame: 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.
measure: Eating disorder symptoms
timeFrame: Assessed at baseline, and at 3 months, 6 months 1 year and 2 years post surgery or pharmacological treatment initiation.
measure: Post-partum depression risk
timeFrame: Assessed in the birth cohort at 2 months post-partum.
measure: Gut microbiome composition
timeFrame: 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.
measure: Nutritional composition of human milk
timeFrame: Assessed at 2 months post-partum in the birth cohort.
measure: Urinary serotonine
timeFrame: 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.
measure: Height
timeFrame: 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.
measure: Waist circumference
timeFrame: 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.
measure: Hip circumference
timeFrame: 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.
measure: Weight
timeFrame: 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.
measure: General information
timeFrame: 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.
measure: General information pregnancy
timeFrame: Assessed during first, second and third trimester.
measure: Fat mass
timeFrame: 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.
Locations:
city: Elst
country: Netherlands
facility: Rijnstate Elst, Vitalys
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Agnes Berendsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: