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| Name | Class |
|---|---|
| Stjørdal Municipally | UNKNOWN |
| Lifeness AS | UNKNOWN |
| National patient organization (LFO) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Experimental | Standard follow-up at respective Healthy Lives Center, including daily logging in the digital therapeutic app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Management | Behavioral | Behavioral intervention for lifestyle change |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frisklivssentralen Værnesregionen | Stjørdal | Trøndelag | 7500 | Norway | ||
| Norwegian University of Science and Technology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41035564 | Derived | 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. |
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Collected data at baseline and w12 (anthropometrics, BMI, eating behavior and quality of life) can be shared upon request
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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RCT
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| 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. |
|
A validated quistionaire assessing weight-related quality of life (IWQOL-Lite) will be handed out at baseline and after 12 weeks |
| 12 weeks |
| Trondheim |
| Trøndelag |
| 7030 |
| Norway |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |