An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment

NCT03380598 | Completed

• 1 other identifier: CLOSS100
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

This study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. Changes in BMI standard deviation score are compared between usual care (control) and usual care with complementary web-based support system (intervention).

Conditions

Childhood Obesity

Keywords

Mobile Health, Self-Monitoring, Behavioural Treatment

Outcome Measures

Primary Outcomes (1)

• Familie's experience and feasibility of the treatment

  CLOSS specific questionnaire, control vs intervention

  6 months after baseline

Secondary Outcomes (2)

• Health care professional's required working time for control vs intervention

  During the intervention 6 months

• Health care professional's experience using the web based support system

  During the intervention 3 and 6 months

Other Outcomes (2)

• Change in BMI Standard Deviation Score

  During the intervention 3 and 6 months

• Familie's compliance

  During the intervention 6 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care according to regular treatment routines at the clinic during 6 months.

Behavioral: Usual care

CLOSS

ACTIVE COMPARATOR

Usual care plus using a web based support system for self-monitoring weight at physical activity.

Behavioral: CLOSS

Interventions

CLOSS BEHAVIORAL

Usual care plus using mobile application's to register weight and physical activity as well as for communication with the clinic. A web-based system enables health care professionals to follow the the patient's daily weight registration online.

CLOSS

Usual care BEHAVIORAL

Usual care. The child and parent(s) at regular visits to the nurse at the clinic

Usual care

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Obesity according to International Obesity Task Force (IOTF)
• Swedish speaking parents
• Parents able to use a smart phone
• No pharmacological treatment that could intervene the obesity treatment

You may not qualify if:

• Diagnosed with or undergoing assessment of neuropsychiatric disorder
• Structured obesity treatment the past 6 months
• Hypothalamic obesity

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (3)

National Childhood Obesity Center, Karolinska University hospital

Huddinge, Sweden

Location

Outpatient paediatric clinic at Norrtälje Hospital

Norrtälje, Sweden

Location

Outpatient paediatric clinic at Södertälje Hospital

Södertälje, Sweden

Location

Related Publications (1)

• Johansson L, Hagman E, Danielsson P. A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. BMC Pediatr. 2020 Sep 23;20(1):447. doi: 10.1186/s12887-020-02338-9.

  PMID: 32967638 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Pernilla Danielsson, PhD

  Karolinska Institutet

  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: PhD Pediatric Nurse

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 21, 2017
• Study Start: September 20, 2017
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

SE (3)