The MOnitor the NUtritional Consequences of Obesity (MONUCO) study addresses a growing clinical need: while surgical and pharmacological obesity treatment effectively reduces body weight and obesity-related comorbidities, these interventions may impair nutrient status. Most treated patients are female and of reproductive age, raising specific concerns about long-term maternal health and potential effects on offspring born after obesity treatment. MONUCO aims to characterise nutritional changes after obesity treatment and link these changes to clinical outcomes for women and their children.
MONUCO is a multicentre prospective cohort study with an integrated pregnancy and birth cohort. The study follows participants from pretreatment through predefined post-treatment intervals up to 10 years. The principal objective is to document dietary intake and biochemical nutrient status over time after either surgical or pharmacological obesity treatment, and to evaluate associations between nutritional status and health domains including musculoskeletal, reproductive, endocrine, gastrointestinal and mental health. The nested pregnancy and birth cohort intends to assess pregnancy-specific nutrient status, foetal growth, child development and human milk composition among women with a history of obesity treatment.
The study will include at least 1,150 women living with obesity who are scheduled to undergo either surgical or pharmacological obesity treatment. Eligible participants are aged 18–55 years. The source does not report additional inclusion or exclusion criteria, nor does it describe how participants will be recruited or allocated between treatment modalities.
Assessments are scheduled pretreatment and at 3 months, 6 months and yearly thereafter for up to 10 years. This longitudinal framework enables evaluation of both short-term and long-term nutritional consequences and related health outcomes. The source does not provide exact timing windows, strategies for retention, or planned interim analyses.
Data will be collected using a combination of physical measurements, questionnaires and biological specimens. Biological samples specified include urine, blood and faeces. Questionnaire-based and objective measures will capture dietary intake, lifestyle factors and clinical parameters relevant to the study domains. The source does not list specific questionnaires, laboratory assays, or the exact panel of nutritional biomarkers to be measured.
Pregnant participants with a history of obesity treatment will be followed throughout pregnancy and after delivery as part of the integrated pregnancy and birth cohort. Additional data specific to this subcohort will include nutrient status during pregnancy, measures of foetal growth, assessments of child development and analysis of human milk composition. The source does not state the timing of pregnancy visits, the age range of offspring at follow-up, or the instruments planned for developmental assessment.
The study will evaluate associations between post-treatment dietary intake and nutrient status and multiple health domains. These include:
Musculoskeletal health
Reproductive health
Endocrine function
Gastrointestinal health
Mental health
For the pregnancy cohort, outcomes extend to foetal growth, child development and human milk composition. Specific primary and secondary endpoints, thresholds for nutrient deficiency, and analytic approaches are not detailed in the source text.
MONUCO received ethical approval from the Medical Ethical Committee Oost-Nederland, Nijmegen, the Netherlands (NL86647.091.24). The study is registered on ClinicalTrials.gov under identifier NCT06945016, with registration performed in the pre-results stage. Results are planned to be disseminated through scientific abstracts, posters, oral presentations at conferences and publications in peer-reviewed journals; findings may also be shared with study participants and the general public via other platforms. The source does not provide a detailed dissemination timeline or planned data-sharing policy.
Note: Details not reported in the source include specific inclusion/exclusion criteria beyond age and sex, recruitment methods, the precise list of nutritional biomarkers and questionnaires, statistical analysis plans, and retention strategies. These elements will be defined by the study investigators but were not described in the provided article summary.