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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-6149 | Other Identifier | WHO |
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The purpose of this study is to collect information for scientific research and to better understand the experiences of participants managing their weight. The study aims to collect valid responses through online interviews from participants. This study is a survey-based study without collection of laboratory data. Duration of the study will be about 14 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline | 0 - 8 weeks post-initiation, individuals who self-reported an initiation date as day, month and year combination that is no more than eight weeks prior to the date that they complete the screener to participate in the study. |
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| End of Escalation Phase | 16 - 24 weeks post-initiation, individuals who self-reported an initiation date as day, month and year combination that is at least 16 weeks but no more than 24 weeks prior to the date that they complete the screener to participate in the study. |
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| Weight Loss Phase | 48 - 56 weeks post-initiation, individuals who self-reported an initiation date as day, month and year combination that is at least 48 weeks but no more than 56 weeks prior to the date that they complete the screener to participate in the study |
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| Stable Weight Phase | More than or equal to (≥) 68 weeks post-initiation, individuals who self-reported an initiation date as day, month and year combination that is at least 68 weeks prior to the date that they complete the screener to participate in the study. |
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| Healthcare Providers (HCP)s | HCPs will be recruited from an opt-in panel available in each country which includes the practitioners representing different settings of obesity care. Qualified HCPs will be invited to participate in a one-on-one IDI with a moderator from each of the participating countries. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | No treatment given |
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| Measure | Description | Time Frame |
|---|---|---|
| Description of characteristics, including clinical, demographic and physical characteristics, among individuals initiated on injectable semaglutide for weight management | Patient Quantitative Segment Multi select from a defined list Single select from a defined list Numeric entry Open-ended type-in Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Description of the experience of individuals initiated on injectable semaglutide for weight management through personal perception of physical and mental health and self-reported QoL | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates extremely dissatisfied and 7 indicates extremely satisfied) Single select from a defined list EQ-5D-5L Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Individual-reported change in BMI since initiation | Patient Quantitative Segment Numeric entry (BMI calculated based on self-reported height and weight) | At the time of survey response (Day 1) |
| Individual-reported achievement of weight loss goal | Patient Quantitative Segment Yes/No; percentage of weight loss goal achieved Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Individual-reported change in weight since initiation | Patient Quantitative Segment Numeric entry in (kgs); percentage of weight change Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Individual-reported changes in daily life since initiation on injectable semaglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment expectation of individuals initiated on injectable semaglutide of ability to achieve weight loss goal using injectable semaglutide | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates not at all confident and 7 indicates extremely confident) Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
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Inclusion Criteria:
For an eligible participant (individuals initiated on injectable semaglutide for weight management), all inclusion criteria must be answered "yes".
For an eligible participant (HCPs), all inclusion criteria must be answered "yes".
Exclusion Criteria:
For an eligible participant (individuals initiated on injectable semaglutide for weight management), all exclusion criteria must be answered "no".
For an eligible participant (HCPs), all exclusion criteria must be answered "no".
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This study will collect quantitative and qualitative data from individuals treated with injectable semaglutide for weight management in real-world settings.
The study will include two groups of participants:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Bad Oeynhausen | 32545 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Patient Qualitative Segment Open-ended commentary |
| At the time of survey response (Day 1) |
| Expectation for length of time of treatment to desired result from date of initiation on injectable semaglutide at baseline | Patient Quantitative Segment Numeric entry months Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Expectation of individuals initiated on injectable semaglutide for weight management who believe they will have greater success in achieving their weight loss with the use of injectable semaglutide | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Expected benefits of injectable semaglutide | Patient Quantitative Segment Multi select from a defined list | At the time of survey response (Day 1) |
| Satisfaction with weight loss since initiation | Patient Quantitative Segment 7-point Likert scale for satisfaction (where 1 indicates extremely dissatisfied all and 7 indicates extremely satisfied) Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Overall satisfaction with injectable semaglutide | Patient Quantitative Segment 7-point Likert scale for satisfaction (where 1 indicates extremely dissatisfied all and 7 indicates extremely satisfied) Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Individual-reported changes in perception of injectable semaglutide since initiation | Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Attitudes of individuals related to obesity or weight related stigmatization or discrimination prior to/since/due to initiation on injectable semaglutide | Patient Quantitative Segment Multi select from a defined list | At the time of survey response (Day 1) |
| Attitudes of individuals initiated on injectable semaglutide for weight management related to obesity as a chronic disease | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) | At the time of survey response (Day 1) |
| Attitudes of individuals initiated on injectable semaglutide for weight management related to weight loss being their responsibility | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) | At the time of survey response (Day 1) |
| Attitudes of individuals initiated on injectable semaglutide for weight management related to weight loss being more likely with use of prescription medication for weight loss (AOMs) | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) | At the time of survey response (Day 1) |
| Degree of knowledge of individuals initiated on injectable semaglutide for weight management related to how prescription weight loss medications (AOMs) work in the body | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Behaviours of individuals initiated on injectable semaglutide for weight management related to making lifestyle changes in addition to initiating on injectable semaglutide for weight loss or weight management to achieve their weight loss goals | Patient Quantitative Segment Multi select from a defined list Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Attitudes of individuals initiated injectable semaglutide for weight management related to the necessity to make lifestyle changes in addition to initiating injectable semaglutide for weight loss or weight management to achieve their weight loss goals | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Attitudes of individuals who initiated on injectable semaglutide for weight management relating to ease of maintaining lifestyle changes (e.g., eating a healthy diet and getting regular exercise) since initiating on injectable semaglutide | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) | At the time of survey response (Day 1) |
| Individual-reported change in overall knowledge of how AOMs work from initiation on injectable semaglutide to present day | Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) | At the time of survey response (Day 1) |
| Attitudes related to viewing obesity as a chronic disease | HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary | At the time of survey response (Day 1) |
| Attitudes related to belief weight loss is solely an individual's responsibility | HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary | At the time of survey response (Day 1) |
| Attitudes related to belief weight loss requires use of prescription medication for weight loss (AOMs) | HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary | At the time of survey response (Day 1) |
| Attitudes related to belief individuals must make lifestyle changes in addition to initiating on injectable semaglutide for weight loss or weight management to achieve their weight loss goals | HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary | At the time of survey response (Day 1) |
| Attitudes related to belief individuals will have greater success in achieving their weight loss goals with use of injectable semaglutide | HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary | At the time of survey response (Day 1) |
| Attitudes related to level of comfort prescribing AOMs and injectable semaglutide specifically for weight management | HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary | At the time of survey response (Day 1) |
| Reasons for length of adherence | Patient Quantitative Segment Multi select from a defined list Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Future planned use of injectable semaglutide (among current users) | Patient Quantitative Segment Multi select from a defined list; Numeric entry months Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Reasons for discontinuation (among those who discontinued) | Patient Quantitative Segment Multi select from a defined list Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Likelihood to resume injectable semaglutide (specifically for weight management) after formal discontinuation and reasons | Patient Quantitative Segment 7-point Likert scale for likelihood (where 1 indicates not at all likely and 7 indicates extremely likely) Multi select from a defined list Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Individual-reported likelihood of continuation on injectable semaglutide until achieve goal weight and reasons | Patient Quantitative Segment 7-point Likert scale for likelihood (where 1 indicates not at all likely and 7 indicates extremely likely) | At the time of survey response (Day 1) |
| Likelihood of continuation on injectable semaglutide after achieving weight loss goal and reasons | Patient Quantitative Segment 7-point Likert scale for likelihood (where 1 indicates not at all likely and 7 indicates extremely likely) | At the time of survey response (Day 1) |
| Treatment pause initiated by individual and reasons | Patient Quantitative Segment Yes/No; Numeric entry; Multi select from a defined list Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Treatment pause initiated by HCP and reasons | Patient Quantitative Segment Yes/No; Numeric entry; Multi select from a defined list Patient Qualitative Segment Open-ended commentary | At the time of survey response (Day 1) |
| Number of treatment pauses | Patient Quantitative Segment Numeric entry | At the time of survey response (Day 1) |
| Among those with low likelihood to use injectable semaglutide after discontinuation, potential use of another AOM | Patient Quantitative Segment Yes/No/Not Sure | At the time of survey response (Day 1) |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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