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Published in: BMC Public Health 1/2016

Open Access 01-12-2016 | Study protocol

Study Protocol: A randomized controlled trial evaluating the effect of family-based behavioral treatment of childhood and adolescent obesity–The FABO-study

Authors: Hanna F. Skjåkødegård, Yngvild S. Danielsen, Mette Morken, Sara-Rebekka F. Linde, Rachel P. Kolko, Katherine N. Balantekin, Denise E. Wilfley, Pétur B. Júlíusson

Published in: BMC Public Health | Issue 1/2016

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Abstract

Background

The purpose of the FABO-study is to evaluate the effect of family-based behavioral social facilitation treatment (FBSFT), designed to target children’s family and social support networks to enhance weight loss outcomes, compared to the standard treatment (treatment as usual, TAU) given to children and adolescents with obesity in a routine clinical practice.

Methods

Randomized controlled trial (RCT), in which families (n = 120) are recruited from the children and adolescents (ages 6–18 years) referred to the Obesity Outpatient Clinic (OOC), Haukeland University Hospital, Norway. Criteria for admission to the OOC are BMI above the International Obesity Task Force (IOTF) cut-off ≥ 35, or IOTF ≥ 30 with obesity related co-morbidity. Families are randomized to receive FBSFT immediately or following one year of TAU. All participants receive a multidisciplinary assessment. For TAU this assessment results in a plan and a contract for chancing specific lifestyle behaviors. Thereafter each family participates in monthly counselling sessions with their primary health care nurse to work on implementing these goals, including measuring their weight change, and also meet every third month for sessions at the OOC. In FBSFT, following assessment, families participate in 17 weekly sessions at the OOC, in which each family works on changing lifestyle behaviors using a structured cognitive-behavioral, socio-ecological approach targeting both parents and children with strategies for behavioral maintenance and sustainable weight change.
Outcome variables include body mass index (BMI; kg/m2), BMI standard deviation score (SDS) and percentage above the IOTF definition of overweight, waist-circumference, body composition (bioelectric impedance (BIA) and dual-X-ray-absorptiometry (DXA)), blood tests, blood pressure, activity/inactivity and sleep pattern (measured by accelerometer), as well as questionnaires measuring depression, general psychological symptomatology, self-esteem, disturbed eating and eating disorder symptoms. Finally, barriers to treatment and parenting styles are measured via questionnaires.

Discussion

This is the first systematic application of FBSFT in the treatment of obesity among youth in Norway. The study gives an opportunity to evaluate the effect of FBSFT implemented in routine clinical practice across a range of youth with severe obesity.

Trial registration

ClinicalTrails.gov NCT02687516. Registered 16th of February, 2016
Appendix
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Metadata
Title
Study Protocol: A randomized controlled trial evaluating the effect of family-based behavioral treatment of childhood and adolescent obesity–The FABO-study
Authors
Hanna F. Skjåkødegård
Yngvild S. Danielsen
Mette Morken
Sara-Rebekka F. Linde
Rachel P. Kolko
Katherine N. Balantekin
Denise E. Wilfley
Pétur B. Júlíusson
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2016
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-016-3755-9

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