Monitoring Nutritional Consequences of Obesity Treatment on Women's Health

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorWageningen University and Research

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,150 Participants
are grouped into 2 trial groups
Group A: General cohort
Group B: Birth cohort

Trial outcomes

Primary outcomes

1

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.

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.
2

Handgrip strength

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.
3

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.

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.
4

Bone mineral density

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.

Secondary outcomes

1

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.

Time frame
Assessed at 2 months, 1 year and 4 years post-partum.
2

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.

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.
3

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.

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.
4

Sleep time

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.

Other outcomes

1

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.

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.
2

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.

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.
3

Self-esteem

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, 2 years, 3 years, 4 years, 5 years and 10 years post surgery or pharmacological treatment initiation.
4

Eating disorder symptoms

Assessed with the eating disorder examination questionnaire (EDE-Q).

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.

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