Childhood Obesity Treatment - Telephone Coaching vc Usual Care

June 8, 2016 updated by: Pernilla Danielsson, Sodertalje Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care, individual visits
Usual care according to regular treatment routines at the clinic during 18 months. The Child and parent(s) at regular visits to the nurse at the clinic.
Behavioral: Usual care, individual visits
Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
Active Comparator: Telephone coaching
Intervention: Telephone consultation each months except for summer holidays during 18 months. The treating nurse communicated with one of the parents.
Behavioral: Telephone coaching
Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI Standard Deviation Score (units)
Time Frame: From start of treatment, during intervention and follow-up. In total mean 3,7 years
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working time required for the Health care personnel
Time Frame: During the intervention 18 months
Mean time for each group measured in minutes
During the intervention 18 months
Families experience of the treatment
Time Frame: During the intervention 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sodertalje Hospital

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Pernilla Danielsson, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • So100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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