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Childhood Obesity Treatment - Telephone Coaching vc Usual Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02794090
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 9, 2016
Karolinska Institutet
Information provided by (Responsible Party):
Pernilla Danielsson, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Usual care, individual visits Behavioral: Telephone coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exclusive Telephone Coaching in Maintaining Weight Loss - An Randomized Controlled Trial of Childhood Obesity Treatment
Study Start Date : May 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : January 2013

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Working time required for the Health care personnel [ Time Frame: During the intervention 18 months ]
    Mean time for each group measured in minutes

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02794090

Sponsors and Collaborators
Sodertalje Hospital
Karolinska Institutet
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Principal Investigator: Pernilla Danielsson, PhD Karolinska Institutet
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Responsible Party: Pernilla Danielsson, PhD pediatric nurse, Karolinska Institutet Identifier: NCT02794090    
Other Study ID Numbers: So100
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pernilla Danielsson, Karolinska Institutet:
Behavioral treatment
Telephone coaching
Outpatient clinic
Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight