Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment

Not Applicable

Completed

• Conditions: Childhood Obesity
• Interventions: Behavioral: Usual care; Behavioral: CLOSS

• Registration Number: NCT03566771
• Lead Sponsor: Karolinska Institutet

Brief Summary

This study aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. Changes in BMI standard deviation score (SDS) are compared between usual care (control) and usual care with complementary web-based support system (intervention).

Detailed Description

In this study children with obesity will be randomized to either usual care according to regular routine (control) or to usual care plus a web-based support system (intervention). Based on previous reviews on mobile health and obesity in combination with the investigators' experiences of childhood obesity treatment components were identified which the researchers hypothesize are of major importance for a web-based system for childhood obesity treatment: Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback from the treatment team. The system is based on a smart phone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smart phone, where data is presented graphically. The data is further transferred to the clinic for support and communication between the clinic and the parents. The randomization will be done at the start of individual treatment and will last for 12 months. The main aim is to evaluate if use of the web-based support system will give better results on degree of obesity compared with usual care.

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-06-25
• Primary Completion: 2019-11-26
• Study Completion: 2019-11-26
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Obesity according to International Obesity Task Force (IOTF)
• Swedish speaking parents
• Parents able to use a smart phone
• Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25

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Exclusion Criteria

• Diagnosed with or undergoing assessment of neuropsychiatric disorder
• Hypothalamic obesity
• Pharmacological treatment that could intervene the obesity treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Usual care according to regular treatment routines at the clinic during 12 months
CLOSS	CLOSS	Usual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months

Primary Outcome Measures

Name	Time	Method
Changes in degree of obesity	6 and 12 months after baseline	Measured by BMI standard deviation score control vs intervention

Secondary Outcome Measures

Name	Time	Method
Physical activity level	During the intervention 12 months	Measured by time and intensity through the activity measuring wrist-band. Only intervention
Number of physical visits	During the intervention 12 months	Control vs intervention
Time consumption for the health care professionals	During the intervention 12 months	Time for physical visits, communication and documentation reported by health care professionals. Control vs intervention
Parental experience of treatment	During the intervention 3, 6 and 12 months	Measured by web-based CLOSS specific questions. Control vs intervention
Cancelation of physical visits	During the intervention 12 months	Control vs intervention
Health care professional's experiences using the web-based support system	During the intervention 3, 6 and 12 months	CLOSS specific questions regarding the application

Trial Locations

Locations (10)

Outpatient pediatric clinic at Hisingen; 🇸🇪 Göteborg, Sweden

Outpatient pediatric clinic in Kungshöjd; 🇸🇪 Göteborg, Sweden

Outpatient pediatric clinic at Hässleholm hospital; 🇸🇪 Hässleholm, Sweden

Outpatient pediatric clinic at Helsingborg hospital; 🇸🇪 Helsingborg, Sweden

Outpatient pediatric clinic at Karlstad hospital; 🇸🇪 Karlstad, Sweden

Outpatient pediatric clinic, Hälsan Barnmottagning; 🇸🇪 Jönköping, Sweden

Pediatric clinic, Umeå University Hospital; 🇸🇪 Umeå, Sweden

Outpatient pediatric clinic at Ystad hospital; 🇸🇪 Ystad, Sweden

Outpatient pediatric clinic at Västerås central hospital; 🇸🇪 Västerås, Sweden

Outpatient pediatric clinic at Nacka hospital; 🇸🇪 Stockholm, Sweden