MOnitoring NUtritional COnsequences of Obesity Treatment on Women's Health and Transgenerational Effects for Healthier Future Generations: a Multicentre Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,150
- 试验地点
- 1
- 主要终点
- Body composition analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Body composition analysis
时间窗: 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.
Handgrip strength
时间窗: 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.
Timed Chair-stand-test/Five Times Sit to Stand test
时间窗: 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.
Proton density fraction in the bone marrow
时间窗: 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.
Bone mineral density
时间窗: 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.
Lean mass
时间窗: 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.
Peak torque of knee extensors and flexors
时间窗: 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.
Total work of knee extensors and flexors
时间窗: 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.
Bone formation
时间窗: 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.
Bone resorption
时间窗: 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.
Proton density fraction in the muscles of the thigh and back
时间窗: 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.
Habitual dietary intake
时间窗: 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.
Actual dietary intake
时间窗: 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.
Nutrient status
时间窗: 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.
Neonatal birth weight
时间窗: Directly after birth
Neonatal birth weight, weight-for-age percentile and classification of small-for-gestational age.
Calcaneal Speed of Sound
时间窗: Assessed during first trimester, third trimester and 1 year post-partum.
Speed of Sound in measured in the calcaneus with a quantitative ultrasound machine.
Calcaneal Broadband Ultrasound Attenuation
时间窗: Assessed during first trimester, third trimester and 1 year post-partum.
Broadband ultrasound attenuation in measured in the calcaneus with a quantitative ultrasound machine.
Diet quality
时间窗: 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.
Neonatal nutrient status
时间窗: Assessed in the birth cohort at birth.
Presence of nutrient deficiencies measured in cord blood collected after birth.
Fetal growth: biparietal diameter
时间窗: Assessed in first trimester, second trimester and third trimester.
Biparietal diameter measured during prenatal ultrasounds.
Fetal growth: abdominal circumference
时间窗: Assessed in first trimester, second trimester and third trimester.
Abdominal circumference measured during the prenatal ultrasounds.
Fetal growth: femur length
时间窗: Assessed in first trimester, second trimester and third trimester.
Femur length measured during the prenatal ultrasounds.
Fetal growth: head circumference
时间窗: Assessed in first trimester, second trimester and third trimester.
Head circumference measured during the prenatal ultrasounds.
Fetal growth: frontal occipital diameter
时间窗: Assessed in first trimester, second trimester and third trimester.
Frontal occipital diameter measured during the prenatal ultrasounds.
Estimated fetal weight
时间窗: Assessed in first trimester, second trimester and third trimester.
Estimated based on prenatal ultrasounds.
次要结局
- General information on child growth and development(Assessed at 2 months, 1 year and 4 years post-partum.)
- 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 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(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)(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(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(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(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(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(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(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 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 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 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 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 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 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 at 3 months, 6 months and 1 year post surgery or pharmacological treatment initiation.)
- Stool pattern(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 in the birth cohort during first, second and third trimester.)
研究者
Agnes Berendsen
Assistant Professor
Wageningen University and Research