Smart Nutrition, Healthier Communities

Smart Nutrition, Healthier Communities: A Digital Therapeutic Strategy for Early Obesity Intervention

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.

Study Overview

• Status: Completed
• Conditions: Obesity and Overweight
• Intervention / Treatment: Behavioral: Lifestyle Management; Device: Intervention; Device: Control

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trøndelag
    • Stjørdal, Trøndelag, Norway, 7500
      • Frisklivssentralen Værnesregionen
    • Trondheim, Trøndelag, Norway, 7030
      • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Behavioral intervention for lifestyle change; Device: Intervention; Full access to DTx function in the app, and digital follow up/communication with helthcare professionals at the Healthy Lives Center
Experimental: Control; Standard follow-up at respective Healthy Lives Center, including daily logging in the digital therapeutic app.	Behavioral: Lifestyle Management; Behavioral intervention for lifestyle change; Device: Control; Basic access to the app (daily logging functions). No digital follow up or communication with healthcare professionals at the Healthy Lives Center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating behavior and hedonic appetite	Validated quistionaires assessing hedonic appetite and eating behavior will be measured at baseline and after 12 weeks: Dutch Eating Behavior Questionnaire (DEBQ), Three Factor Eating Questonnaire (TFEQ), and the Power of Food Scale (PFS).	12 weeks
Weight related quality of life	A validated quistionaire assessing weight-related quality of life (IWQOL-Lite) will be handed out at baseline and after 12 weeks	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasability	Engagement in the app will be evaluated by monitoring the participants check-in streaks and progress in the DTx programme during the intervention. Usability and feasbility for both study participants and healthcare professionals will be evaluted through a standardized validation form at the end of the 12 week intervention.	12 weeks

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Stjørdal Municipally; Lifeness AS; National patient organization (LFO)

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 774938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Collected data at baseline and w12 (anthropometrics, BMI, eating behavior and quality of life) can be shared upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No