Obesity and Overweight
Conditions
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.
Interventions
BEHAVIORALLifestyle Management
Behavioral intervention for lifestyle change
DEVICEIntervention
Full access to DTx function in the app, and digital follow up/communication with helthcare professionals at the Healthy Lives Center
DEVICEControl
Basic access to the app (daily logging functions). No digital follow up or communication with healthcare professionals at the Healthy Lives Center.
Sponsors
Stjørdal Municipally
Lifeness AS
National patient organization (LFO)
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 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
| Measure | Time frame | Description |
|---|---|---|
| Eating behavior and hedonic appetite | 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). |
| Weight related quality of life | 12 weeks | A validated quistionaire assessing weight-related quality of life (IWQOL-Lite) will be handed out at baseline and after 12 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasability | 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. |
Countries
Norway
Outcome results
None listed