Rijnstate Elst, Vitalys
Elst, Gelderland, 6662 NC, Netherlands
Location status: Recruiting
NCT Number: NCT06945016
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.
Interested in participating?
Request Info18 year–55 year
Female
Observational
Elst, Gelderland, 6662 NC, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
General Inclusion Criteria:
Additional inclusion criteria for birth cohort:
General Exclusion Criteria:
Additional exclusion criteria birth cohort:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Directly after birth
Neonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.
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.
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.
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.
Time frame: Assessed in the birth cohort at birth.
Presence of nutrient deficiencies measured in cord blood collected after birth.
Time frame: Assessed in first trimester, second trimester and third trimester.
Biparietal diameter measured during prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Abdominal circumference measured during the prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Femur length measured during the prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Head circumference measured during the prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Frontal occipital diameter measured during the prenatal ultrasounds.
Time frame: Assessed in first trimester, second trimester and third trimester.
Estimated based on prenatal ultrasounds.
Time frame: Assessed at 2 months, 1 year and 4 years post-partum.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. In the birth cohort it is assessed at 1 year post-partum.
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.
Assessed using a custom made questionnaire containing questions menopausal complaints and the use of hormones.
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.
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.
Assessed with the Rome VI criteria.
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.
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.
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.
Assessed with the quality of alimentation questionnaire.
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.
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 in the birth cohort during first, second and third trimester.
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 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.
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.
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.
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.
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.
Assessed with the Rosenberg self-esteem scale (RSE). The score ranges between 0 and 30 with higher scores indicating better self-esteem.
Time frame: 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.
Assessed with the eating disorder examination questionnaire (EDE-Q).
Time frame: Assessed in the birth cohort at 2 months post-partum.
Assessed with the Edinburg postnatal depression scale (EPDS). The score ranges from 0 to 30 with higher scores indicating more severe depression symptoms.
Time frame: 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.
Assessed in by extracting DNA from collected stool samples.
Time frame: Assessed at 2 months post-partum in the birth cohort.
The macro and micronutrient content of human milk samples.
Time frame: 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.
Assessed in spot urine samples. The second urine of the day is collected.
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. Additionally in the birth cohort during first, second, and third trimester.
Height measured in cm with a stadiometer.
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.
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.
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.
Measured in cm at the height of the greater trochanter with a non-elastic tape measure. Average of two measurements is used.
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. Additionally in the birth cohort during first, second, and third trimester.
Weight measured in kg with calibrated scales.
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.
Participants complete a general questionnaire to gather information on sociodemographic factors, medical conditions or complications, medications, smoking, alcohol consumption and drug use.
Time frame: Assessed during first, second and third trimester.
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.
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 fat mass assessed with a DEXA scan.
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 liver obtained through an MRI scan.
Wageningen University and Research
Other
MOnitoring NUtritional COnsequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study
Acronym: MONUCO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06721507
Bariatric Surgery, Body Weight
Lexington, Kentucky, United States
View Trial DetailsNCT06802861
Body Weight, Diabetes Mellitus
Knoxville, Tennessee, United States
View Trial DetailsNCT07011628
Bariatric Surgery, Body Weight
Nashville, Tennessee, United States
View Trial DetailsNCT06890975
Behavior, Body Weight
Sommerville, Massachusetts, United States
View Trial Details