Smart Nutrition, Healthier Communities

NCT ID: NCT06667843

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity and Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

Behavioral intervention for lifestyle change

Intervention

Intervention Type DEVICE

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

Control

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

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

Behavioral intervention for lifestyle change

Control

Intervention Type DEVICE

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

Interventions

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Lifestyle Management

Behavioral intervention for lifestyle change

Intervention Type BEHAVIORAL

Intervention

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

Intervention Type DEVICE

Control

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stjørdal Municipally

UNKNOWN

Sponsor Role collaborator

Lifeness AS

UNKNOWN

Sponsor Role collaborator

National patient organization (LFO)

UNKNOWN

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Frisklivssentralen Værnesregionen

Stjørdal, Trøndelag, Norway

Site Status

Norwegian University of Science and Technology

Trondheim, Trøndelag, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 41035564 (View on PubMed)

Other Identifiers

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774938

Identifier Type: -

Identifier Source: org_study_id

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