A Study to Determine the Feasibility of Online Recruitment of People Using an Anti-Obesity Medication for Weight Loss

Amgen200 enrolled

Overview

This observational study is designed to determine the feasibility of recruitment from a digital research community of people using an anti-obesity medication for weight loss to understand willingness to consent to survey research and at home self-blood testing. This study will engage an active community of people using anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss to examine the willingness of participants to engage in a digital study, provide consent, and complete various study-related tasks, including a self-collected capillary blood sample for assay testing and health related surveys.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Obesity

Interventions

TAP® Micro Select Device (Touch Activated Phlebotomy)DEVICE

The TAP Micro Select device will be used in an investigational capacity by participants for self-collection of whole capillary blood.

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Adults 18 - 80 years of age. * Living in the United States. * Consented from the Inspire online platform patient community for COSMOS-DIGITAL. * Self-Reported current use of, and intention to continue for at least 30 days, one of the following medications for the indications of weight management/obesity: * Semaglutide (wegovy) * Tirzepatide (zepbound) Exclusion Criteria: * Currently receiving treatment in another investigational device or drug study, or participation in a current clinical trial. * Self-reported sensitivity/allergy to any of the components of the self-draw collection device including stainless steel or elements commonly found in stainless steel. * Self-reported fear of blood. * Self-reported circulatory conditions causing difficulty in drawing capillary blood. * Known history of bleeding diathesis or any coagulation disorder. * History of skin disorders, abnormal skin integrity or atypical skin health within the areas to be tested in the upper arm.

Outcomes

Primary Outcomes

Number of Participants with Self-blood Draw Received by Central Laboratory

Time frame: 30 days

Secondary Outcomes

Percentage of Consented Participants with Complete Self-reported Survey for Medical History

Time frame: Day 1

Percentage of Consented Participants with Complete Self-reported Survey for Nausea and Nausea Management

Time frame: Day 1 and Day 30

Percentage of Consented Participants with Complete Self-reported Survey for Patient Reported Outcomes in Obesity

Time frame: Day 1 and Day 30

Percentage of Consented Participants with Complete Self-reported Survey for Partners in Health (PiH) Questionnaire

Time frame: Day 1 and Day 30

Percentage of Consented Participants with Complete Self-reported Survey for the Daily Diary

The daily diary will record answers about nausea symptoms.

Time frame: 30 days

Percentage of Consented Participants with Complete Self-reported Survey for the Satisfaction Survey

Participants will be asked about their satisfaction with using the device for the self-blood draw.

Time frame: Day 30

Percentage of Participants with Sufficient Volume of Blood Collected for Sampling

Time frame: 30 days

A Study to Determine the Feasibility of Online Recruitment of People Using an Anti-Obesity Medication for Weight Loss

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes