Smart Nutrition, Healthier Communities

NCT06667843 | Completed

• 1 other identifier: 774938
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

The project investigates the effect of the health app Lifeness as a digital therapeutic (DTx) and follow-up tool in a municipal setting at a regional Healthy Lives Center in central Norway (Frisklivssentralen Værnesregionen), targeting early intervention for overweight and obesity.

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight, and weight circumference, will be measured with standard proceduress (medically approved digital Seca scale (kg), and standard measuring band (cm)) wearing light clothing at baseline and after 12 weeks.

  12 weeks

Secondary Outcomes (2)

• Eating behavior and hedonic appetite

  12 weeks

• Weight related quality of life

  12 weeks

Other Outcomes (1)

• Feasability

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Standard follow-up at respective Healthy Lives Center with the addition of a digital therapeutic app with a full lifestyle program, including daily logging, tasks, articles and general information and possibility for digital communication with their healthcare provider.

Behavioral: Lifestyle Management; Device: Intervention

Control

EXPERIMENTAL

Standard follow-up at respective Healthy Lives Center, including daily logging in the digital therapeutic app.

Behavioral: Lifestyle Management; Device: Control

Interventions

Lifestyle Management BEHAVIORAL

Behavioral intervention for lifestyle change

Control; Intervention

Intervention DEVICE

Full access to DTx function in the app, and digital follow up/communication with helthcare professionals at the Healthy Lives Center

Intervention

Control DEVICE

Basic access to the app (daily logging functions). No digital follow up or communication with healthcare professionals at the Healthy Lives Center.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≤27kg/m2 or obesity measured by waist circumference, current weight stability, motivated to lifestyle change using mobile apps, access to smartphone with 5G. Living in the municipallies covered by the Værnes region of central Norway.

You may not qualify if:

• previous bariatric surgery, use of anti-obesity drugs, pregnancy, current or present cancer diagnosis,substance abuse or psychiatric diagnosis (such as eating disorders), or other conditions that can hinder physical activity.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Stjørdal Municipally: collaborator
• Lifeness AS: collaborator
• National patient organization (LFO): collaborator

Study Sites (2)

Frisklivssentralen Værnesregionen

Stjørdal, Trøndelag, 7500, Norway

Location

Norwegian University of Science and Technology

Trondheim, Trøndelag, 7030, Norway

Location

Related Publications (1)

• Aukan MI, Larsen MA, Melan TI, Salvesen OO. Beyond weight loss: digital therapeutic for behavioral change and psychological well-being for individuals with overweight and obesity in a primary healthcare setting-A randomized controlled pilot study. Front Digit Health. 2025 Sep 16;7:1671649. doi: 10.3389/fdgth.2025.1671649. eCollection 2025.

  PMID: 41035564 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 31, 2024
• Study Start: September 23, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

NO (2)