PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Body Mass Index
Study Overview
Brief Summary
Randomised controlled trial in overweight adolescents using a health App.
Detailed Description
Problem In Switzerland, 20% of children are overweight and novel methods are urgently needed to control the epidemic. Foundations of chronic diseases develop during childhood and track into adulthood obesity in more than 75% of patients, contributing to a significant increase in public health costs.
Multi-professional programs combining physical activity, nutritional and behavioral components have positive effects on therapy outcomes and co-morbidities, but these interventions induce high costs and are time-consuming for health providers, patients and families, in particular those living in rural regions. In fact, less than 0.2% of overweight children can participate in these programs. Thus, health information systems (HIS) have not only the potential to improve outcomes of obesity therapy but also to reduce health costs and increase access to health care in remote regions. Most HIS have indeed not been evaluated in this regard.
Preparation work In the PathMate project (SNF grant #135552), a mobile HIS has been developed for teenagers to support therapy and to prevent obesity in accordance with state-of-the-art multiprofessional programs and, in contrast to commercially available IT applications, with a high standard of data protection and safety. The IS effects of this HIS have been successfully evaluated in first longitudinal studies. In parallel, the impact of multi-professional therapies in Swiss children as well as potential confounders have been established in several longitudinal cohort studies with up to two-years follow-up.
Objectives
The overall goal of PathMate2 is to assess the impact of HIS services on the degree of obesity measured by the body mass index (BMI) incl. other health outcomes. Individual and shared understanding between patients and therapists are assessed as mediating factors. Specific goals are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •obesity, BMI > P. 97 (Jenni et al., 2011) or overweight, BMI >P.90, plus risk factors or co-morbidity
- •ability and parent's permission to use pre-configured study smartphones handed out to the children
- •readiness to use the personal smartphone number and to spend the sum allocated exclusively for the study SMS during the 6 months of intervention
Exclusion Criteria
- •major somatic or psychiatric disease without adequate treatment,
- •weight-relevant medication (antiepileptic drugs, methylphenhydate and similar medication),
- •inability or lack of parent's or caregivers' permission to use a study smartphone with a mobile phone contract,
- •lack of informed consent from children and parents and
- •undue consumption of the amount allocated for study SMS for non-study purposes,
- •overuse of smartphone e.g. without night beak for at least 8 hours.
Arms & Interventions
Control SG
Therapy during 6 months with usual care. 10 therapy visits over 6 months
Intervention SG
Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months
Intervention: PathMate2 (Device)
Intervention VD
Adapted sport session 1h/week + PathMate-S during 6 months
Intervention: PathMateS (Device)
Control VD
Adapted sport session 1h/week during 6 months
Outcomes
Primary Outcomes
Body Mass Index
Time Frame: 12 months
Main outcome parameter is Body Mass Index, as BMI-SDS adjusted for gender \& age. Group size of 4\*20 was based on an expected decrease by -0.23±0.02 (SDS, Mean±SD) after 1 year, from initially 2.88±0.7.
Secondary Outcomes
- stress and arousal(12 months)
- stress and arousal, biophysical measure(12 months)
- well-being(12 months)
- waist circumference(12 months)
- fitness / physical activity(12 months)
- stress reduction, biological measure(12 months)
- reduction of chronic stress(12 months)
- fitness / physical capability(12 months)
Investigators
Dagmar l'Allemand
Prof. Dr. med.
Ostschweizer Kinderspital