Recruiting nowNot applicableObservational
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 55 Years
SexFemale
Healthy volunteersNot accepted
ConditionObesity and Obesity-related Medical Conditions, Bariatric Surgery, Anti-obesity Agents, Body Composition, Muscle Strength, Reproductive Health, Mental Health, Pregnancy, Nutritional Status
Full registry 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
Body composition analysisAssessed 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 strengthAssessed 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 testAssessed 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.
Bone mineral densityAssessed 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 massAssessed 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 flexorsAssessed 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 flexorsAssessed 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 formationAssessed 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.
