About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female sex at birth
Aged 18-55 years of age
Living with obesity (BMI ≥ 30 kg/m2)
Undergoing primary bariatric surgery (RYGB, OAGB or SG)
Disqualifiers
Male sex at birth
Aged <18 or >55 years of age
BMI <30 kg/m2
Not able to read and/or write in Dutch
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Handgrip strength
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
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 density
Total body and hip bone mineral density measured with a DEXA scan.
Secondary outcomes
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.
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.
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.
Sleep time
Assess using an accelerometer (Actigraph). The accelerometer was worn during 7 days at each follow-up measurement.
Other outcomes
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.
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.
Self-esteem
Assessed with the Rosenberg self-esteem scale (RSE). The score ranges between 0 and 30 with higher scores indicating better self-esteem.
Eating disorder symptoms
Assessed with the eating disorder examination questionnaire (EDE-Q).
Sponsors and contacts
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Wageningen University and Research
Lead sponsor
Rijnstate Hospital
Collaborator