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OpenTrials
Completed

NCT Number: NCT06667843

Smart Nutrition, Healthier Communities

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frisklivssentralen Værnesregionen, Stjørdal, Trøndelag, Norway

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lifestyle Management

Behavioral

Behavioral intervention for lifestyle change

Intervention

Device

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

Control

Device

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

Primary outcomes

  1. Body weight

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Eating behavior and hedonic appetite

    Time frame: 12 weeks

    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).

  2. Weight related quality of life

    Time frame: 12 weeks

    A validated quistionaire assessing weight-related quality of life (IWQOL-Lite) will be handed out at baseline and after 12 weeks

Other outcomes

  1. Feasability

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Lifeness AS
  • National patient organization (LFO)
  • Stjørdal Municipally

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Jun 22, 2025

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.

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