A Study Collecting Remote Data in People With an Overweight Condition or Obesity on a Weight Management Program

Novo Nordisk

Status: Active, not recruiting

Conditions: Overweight, Obesity

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT06805539

U1111-1301-4301 (Other Identifier)

NN9536-7632

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

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

Trial design

200 participants in 2 patient groups

Consent video

Description:

Participants watching a pre-recorded consent video.

Treatment:

Other: No treatment given

Video call

Description:

Participants obtaining the information regarding the study at a video call from the study staff.

Treatment:

Other: No treatment given