A Study Collecting Remote Data in People With an Overweight Condition or Obesity on a Weight Management Program
NCT ID: NCT06805539
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2025-04-14
2026-04-30
Brief Summary
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Participants will participate in this study for 24 weeks. The study does not include any study medicine.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Consent video
Participants watching a pre-recorded consent video.
No treatment given
No treatment given
Video call
Participants obtaining the information regarding the study at a video call from the study staff.
No treatment given
No treatment given
Interventions
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No treatment given
No treatment given
Eligibility Criteria
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Inclusion Criteria
2. Willingness to consent via the e-consent process before any study-related activities (study- related activities are any procedure related to recording of data according to the protocol)
3. Male or female, age above or equal to 18 years at the time of signing informed consent
4. Body mass index (BMI) above or equal to 25 kg/m\^2 self-reported in the Confirmation of Eligibility Questionnaire
5. About to initiate/has initiated at least one of the following weight management program(s) :
1. Diet regime aimed at losing weight and/or
2. Exercise regime aimed at losing weight and/or
3. Prescription of any approved anti-obesity medication (according to standard practice) as prescribed by the participant's treating physician
6. Willingness to follow study procedures
7. Willingness to, and capable of using the study devices and app
8. Fluent in oral and written Danish language
9. In possession of a compatible smartphone (minimum Android 10 and iOS14) throughout the study that has a reliable internet connection, regular connection to 4G/5G network, or Wi-Fi and that has the capability of downloading the study app and connecting with the smartwatch, the body composition scale and the data hub)
Exclusion Criteria
2. Participation in any study investigating an overweight condition or obesity
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
4. Type 1 or type 2 diabetes
5. Currently under treatment with any GLP-1 RA with the indication of improving glycaemic control
6. Currently using a pacemaker, an implantable cardioverter-defibrillator (ICD) or cardiac resynchronisation therapy (CRT) due to the electrical effects of the body composition scale
7. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an effective contraceptive method during the study duration
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, , Denmark
Countries
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Other Identifiers
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U1111-1301-4301
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-7632
Identifier Type: -
Identifier Source: org_study_id
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