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

NCT03270423 | Completed

• 1 other identifier: 2016-01965
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Randomised controlled trial in overweight adolescents using a health App.

Conditions

Obesity, Adolescent

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  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.

  12 months

Secondary Outcomes (8)

• fitness / physical capability

  12 months

• fitness / physical activity

  12 months

• stress reduction, biological measure

  12 months

• stress and arousal

  12 months

• reduction of chronic stress

  12 months

Study Arms (4)

Intervention SG

ACTIVE COMPARATOR

Therapy during 6 months with PathMate2 design. 6 therapy visits + PathMate2 over 6 months

Device: PathMate2

Control SG

NO INTERVENTION

Therapy during 6 months with usual care. 10 therapy visits over 6 months

Intervention VD

ACTIVE COMPARATOR

Adapted sport session 1h/week + PathMate-S during 6 months

Device: PathMateS

Control VD

NO INTERVENTION

Adapted sport session 1h/week during 6 months

Interventions

PathMate2 DEVICE

To improve self-regulation of overweight adolescents and subsequently their weight status, we tested, whether a biofeedback relaxation exercise decreases stress and whether relaxation services as well as sensor data integration implemented in a novel Smartphone App supported intervention have effects on stress, physical activity and weight outcomes. During the intensive phase of 6 months, patients of the intervention group (IG) are equipped with a smartphone and a specially designed chat App with game character, which encourages them through a virtual coach to achieve daily activity, healty lifestyle or relaxation challenges and earn virtual rewards, to increase adherance to the health information system.

Also known as: Mobile-coach obesity intervention in adolescents

Intervention SG

PathMateS DEVICE

Overweight or obese adolescents of the treatment as-usual group (CG) have monthly visits on site during the intensive phase. Counseling for physical activity, healthy eating and lifestyle as well as psychosocial wellbeing is provided by a pediatrician.

Also known as: controls

Intervention VD

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ostschweizer Kinderspital: lead

Study Sites (1)

Ostschweizer Kinderspital

Sankt Gallen, Canton of St. Gallen, 9006, Switzerland

Location

Related Publications (2)

• Haug S, Kowatsch T, Castro RP, Filler A, Schaub MP. Efficacy of a web- and text messaging-based intervention to reduce problem drinking in young people: study protocol of a cluster-randomised controlled trial. BMC Public Health. 2014 Aug 7;14:809. doi: 10.1186/1471-2458-14-809.

  PMID: 25099872 BACKGROUND

• Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

  PMID: 38375882 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Infection Control, Dental

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Infection Control; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Dagmar lAllemand, Prof. MD

  Ostschweizer Kinderspital, St. Gallen, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: September 1, 2017
• Study Start: January 30, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)