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.
Study Type
OBSERVATIONAL
Enrollment
1,150
Rijnstate Elst, Vitalys
Elst, Gelderland, Netherlands
RECRUITINGBody 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.
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.
Handgrip strength
Maximal handgrip strength out of three repetitions with both the dominant and non-dominant hand.
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.
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.
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.
Bone mineral density
Total body and hip bone mineral density measured with a DEXA scan.
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.
Lean mass
Total lean mass and appendicular lean mass assessed with a DEXA scan.
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.
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.
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 work of knee extensors and flexors
The work accomplished during 15 repetitions at 180 degrees/second in a isokinetic dynamometer.
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.
Bone formation
P1NP (Total procollagen type 1-teriminal propeptide) measured in a venous blood sample.
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.
Bone resorption
CTX (type-1 collagen) measured in a venous blood sample.
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.
Proton density fraction in the bone marrow
The proton density fat fraction of the bone marrow obtained through an MRI scan.
Time frame: 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.
Time frame: 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.
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.
Actual dietary intake
Assessed with the TRAQQ app, a mobile phone application that performs 9 2 -h recalls on 3 days.
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.
Nutrient status
Presence of nutrient deficiencies.
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.
Neonatal birth weight
Neonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.
Time frame: Directly after birth
Calcaneal Speed of Sound
Speed of Sound in measured in the calcaneus with a quantitative ultrasound machine.
Time frame: 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.
Time frame: Assessed during first trimester, third trimester and 1 year post-partum.
Diet quality
Assessed through the Eetscore, a brief food-frequency questionnaire.
Time frame: 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.
Time frame: Assessed in the birth cohort at birth.
Fetal growth: biparietal diameter
Biparietal diameter measured during prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Fetal growth: abdominal circumference
Abdominal circumference measured during the prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Fetal growth: femur length
Femur length measured during the prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Fetal growth: head circumference
Head circumference measured during the prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Fetal growth: frontal occipital diameter
Frontal occipital diameter measured during the prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Estimated fetal weight
Estimated based on prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
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.
Time frame: 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.
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
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.
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
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
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)
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
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
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Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
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
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
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
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
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
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
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
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
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
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
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
Assessed using a custom made questionnaire containing questions about menstrual history, dysmenorrhoea, menstrual complaints, bleeding and choice of contraceptives.
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
Assessed using a custom made questionnaire containing questions menopausal complaints and the use of hormones.
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
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.
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
Assessed with the Rome VI criteria.
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
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.
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
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.
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
Assessed with the quality of alimentation questionnaire.
Time frame: 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).
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
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.
Time frame: Assessed in the birth cohort during first, second and third trimester.