Clinical trial NCT06805539: A Study Collecting Remote Data in People With an Overweight Condition or Obesity on a Weight Management Program
Official title: Decentralised Observational Disease Area Study Exploring Remote Collection of Data in Adult Participants With Overweight Condition or Obesity Undergoing Weight Management Program
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Overweight, Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with an overweight condition or obesity undergoing weight management prescribed by a general practitioner

Brief summary: The purpose of this study is to collect health data related from participants living with an overweight condition in a decentralised clinical study set-up. All data will be collected remotely using an app downloaded on your personal smartphone and devices (watch and scale).

Participants will participate in this study for 24 weeks. The study does not include any study medicine.


Eligibility criteria: Inclusion Criteria:

1. Informed electronic consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
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
5. Undergoing at least one of the following weight management program(s) as prescribed/ agreed upon by the treating physician:

   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)
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:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
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

Primary outcomes:
measure: Completion of the electronic informed consent process (e-consent)
timeFrame: Week -2 to week 0
measure: Body weight measurements recorded
timeFrame: From week 0 (device set-up date) to the week 24 (end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Steno Diabetes Center Aarhus
city: Søborg
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: