An interventional study of Withings Body Comp Pro in Obesity, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Health services research
This study involves collecting real-world data on body weight, body composition, cardiovascular parameters, and neurovegetative parameters using a connected scale in patients with severe obesity treated with Wegovy®.
Obesity is a chronic disease associated with numerous co-morbidities. New treatments for obesity, notably GLP-1 (Glucagon-like peptide 1) analogs, have led to promising advances. Semaglutide 2.4 mg weekly subcutaneous injection, marketed under the brand name Wegovy®, was recently approved in France for weight loss in patients with severe obesity and at least one comorbidity. Several real-world studies have confirmed the effectiveness of semaglutide in reducing body weight and HbA1c. However, few studies have evaluated the kinetics and interindividual variability of changes in body weight and composition as well as cardiovascular health. There appears to be a need for a comprehensive real-world assessment of patients living with severe obesity receiving Wegovy®.
The TELE-SEMA project involves collecting real-world data on body weight, body composition, cardiovascular and neurovegetative parameters via connected scales in patients with severe obesity treated with Wegovy®.
The main objectives will be to assess inter-individual weight variability and explore the determinants that may influence weight loss, body composition and possible eating disorders.
6,297 studies on the registry are indexed under Obesity; 1,693 are open to participants now.
This study's planned enrollment of 80 is close to the median of 78 across 4,879 interventional studies indexed under Obesity.
Browse Obesity studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receiving connected scale
Device: Withings Body Comp Pro
Withings Body Comp Pro from which the following features will be used: body weight, body composition (fat, muscle and bone mass, cardiovascular health (pulse wave velocity, arterial stiffness, vascular age, standing heart rate), nervous health (electrochemical skin conductance)
The relative difference in weight loss achieved at 6 months of treatment at the maximum tolerated dose ((weight after 6 months of treatment at the maximum tolerated dose - baseline weight) / baseline weight)
Body weight measured at month 0 and 6
Time frame: 6 months
The variation of body weight measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Body weight measured weekly
Time frame: 6 months
The variation of body composition (fat mass, muscle mass, and bone mass) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Body composition measured weekly
Time frame: 6 months
The variation of pulse wave velocity measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Pulse wave velocity
Time frame: 6 months
The variation of arterial stiffness measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Arterial stiffness
Time frame: 6 months
The variation of vascular age measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Vascular age
Time frame: 6 months
The variation of heart rate measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Heart rate
Time frame: 6 months
The variation of nervous system health (electrochemical skin conductance) measured by the connected scale between participants receiving semaglutide at the maximum tolerated dose
Nervous system health measured weekly
Time frame: 6 months
Difference in mean pulse wave velocity before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Pulse wave velocity at month 0 and 6
Time frame: 6 months
Difference in mean arterial stiffness before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Arterial stiffness at month 0 and 6
Time frame: 6 months
Difference in mean vascular age before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Vascular age at month 0 and 6
Time frame: 6 months
Difference in mean heart rate before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Heart rate at month 0 and 6
Time frame: 6 months
Difference in eating behavior assessed by the BES questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Eating behavior at month 0 and 6
Time frame: 6 months
Difference in the level of physical activity assessed by the IPAQ short version questionnaire before and after 6 months of treatment with semaglutide at the maximum tolerated dose
Level of physical activity at month 0 and 6
Time frame: 6 months
Percentage of missed doses compared to the total number of prescribed doses after 6 months of treatment at the maximum tolerated dose
missed doses compared to the total number of prescribed doses at month 6
Time frame: 6 months
Plan to share: Yes — Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Supporting information: Study protocol, Icf
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris