Childhood Obesity Treatment - Telephone Coaching vc Usual Care

Childhood Obesity Clinical Trial

Official title:

Exclusive Telephone Coaching in Maintaining Weight Loss - An Randomized Controlled Trial of Childhood Obesity Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794090
• Other study ID #: So100
• Status: Completed
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 8, 2016
• Start date: May 2007
• Est. completion date: January 2013

Study information

• Verified date: June 2016
• Source: Sodertalje Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter Telephone coaching Contacts during 18 months.

Description:

In this randomized controlled study, patients at age 5 to 14 and enrolled in obesity treatment, were randomized to either usual care according to regular routine or to telephone consultation.The randomization was done at the start of individual treatment and lasted for 18 months. We also studied working time required for the Health care, and the families' experience of the Telephone coaching.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 14 Years

Eligibility

Inclusion Criteria:

• Children 5 to 14 years old who were patients at the outpatient pediatric centre

• All families after that the parents had attended at least 4 of 7 meetings in a parental/education group.

Exclusion Criteria:

• Obesity related syndromes

• Non-Swedish speaking families

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Usual care, individual visits
Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
• Telephone coaching
Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sodertalje Hospital	Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI Standard Deviation Score (units)	BMI Standard Deviation Score units using the Swedish reference by Karlberg et al 2001.	From start of treatment, during intervention and follow-up. In total mean 3,7 years	No
Secondary	Working time required for the Health care personnel	Mean time for each group measured in minutes	During the intervention 18 months	No
Secondary	Families experience of the treatment	Experience for both the Telephone consultation and usual care by not validated anonymous questionnaires constructed by the researchers in this project	During the intervention 18 months	No