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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight, Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Informed electronic consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
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)
Male or female, age above or equal to 18 years at the time of signing informed consent
Body mass index (BMI) above or equal to 25 kg/m^2 self-reported in the Confirmation of Eligibility Questionnaire
About to initiate/has initiated at least one of the following weight management program(s) :

Diet regime aimed at losing weight and/or
Exercise regime aimed at losing weight and/or
Prescription of any approved anti-obesity medication (according to standard practice) as prescribed by the participant's treating physician
Willingness to follow study procedures
Willingness to, and capable of using the study devices and app
Fluent in oral and written Danish language
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

Previous participation in this study. Participation is defined as having given informed consent in this study
Participation in any study investigating an overweight condition or obesity
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Type 1 or type 2 diabetes
Currently under treatment with any GLP-1 RA with the indication of improving glycaemic control
Currently using a pacemaker, an implantable cardioverter-defibrillator (ICD) or cardiac resynchronisation therapy (CRT) due to the electrical effects of the body composition scale
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

Treatment and study plan

No treatment given

Other

No treatment given

Primary outcomes

Completion of the electronic informed consent process (e-consent)

Time frame: Week -2 to week 0

Count
Body weight measurements recorded

Time frame: From week 0 (device set-up date) to the week 24 (end of study)

Count

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Decentralised Observational Disease Area Study Exploring Remote Collection of Data in Adult Participants With Overweight Condition or Obesity Undergoing Weight Management Program

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Feb 3, 2025
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting