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| Name | Class |
|---|---|
| Rijnstate Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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. |
| 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 quality |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
General Inclusion Criteria:
Additional inclusion criteria for birth cohort:
General Exclusion Criteria:
Additional exclusion criteria birth cohort:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Berendsen, PhD | Wageningen University and Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Elst, Vitalys | Recruiting | Elst | Gelderland | 6662 NC | Netherlands |
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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The following samples will be retained: urine, stool, venous blood (serum, plasma and full blood), cord blood and breastmilk.
| 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. |
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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Food intolerances | Assessed with the quality of alimentation questionnaire. | 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). | 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. |
| 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. |
| 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. |
| 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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