Long-term Results of an Interactive Mobile Health Support System and Daily Home-weighing as an add-on to Pediatric Obesity Lifestyle Treatment: A 3-year Pragmatic Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Childhood Obesity
- Sponsor
- Karolinska Institutet
- Enrollment
- 428
- Locations
- 1
- Primary Endpoint
- Change in degree of obesity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.
Detailed Description
Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment. In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app. The present study is a continuation of the investigators previous one-year study, Clinicaltrials.gov ID: NCT04323215. In this follow-up study, the investigators aim to assess the treatment outcomes over a three-year period. The evaluation will be carried out on 107 children who underwent digi-physical treatment for three years. The results will be compared with a matched control group (n=321) from the Swedish childhood obesity treatment register, BORIS.
Investigators
Pernilla Danielsson
Principal Investigator
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •Obesity according to International Obesity Task Force (IOTF)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in degree of obesity
Time Frame: From start of treatment to three years follow-up
Measured by BMI standard deviation score. Digi-physical group vs. control group
Secondary Outcomes
- Number of physical visits(From start of treatment to three years follow-up)
- The use of the support system - weighings(From start of treatment to three years follow-up)
- The use of the support system - text messages(From start of treatment to three years follow-up)
- Number of cancelation of physical visits(From start of treatment to three years follow-up)
- Number of patients not showing up to physical visit(From start of treatment to three years follow-up)