PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03270423
• Date of registration: 26/07/2017
• Prospective Registration: No
• Primary sponsor: Ostschweizer Kinderspital
• Public title: PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers PM2
• Scientific title: PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
• Date of first enrolment: January 30, 2017
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03270423
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Dagmar lAllemand, Prof. MD
• Affiliation: Ostschweizer Kinderspital, St. Gallen, Switzerland

Key inclusion & exclusion criteria

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.



Age minimum: 11 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity, Adolescent

Intervention(s)

Device: PathMateS

Device: PathMate2

Primary Outcome(s)

Body Mass Index [Time Frame: 12 months]

Secondary Outcome(s)

stress and arousal [Time Frame: 12 months]

waist circumference [Time Frame: 12 months]

fitness / physical capability [Time Frame: 12 months]

stress and arousal, biophysical measure [Time Frame: 12 months]

fitness / physical activity [Time Frame: 12 months]

stress reduction, biological measure [Time Frame: 12 months]

reduction of chronic stress [Time Frame: 12 months]

well-being [Time Frame: 12 months]

Secondary ID(s)

2016-01965

Source(s) of Monetary Support

Please refer to primary and secondary sponsors