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

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

doi:10.1186/s12889-016-3755-9

Abstract

BackgroundThe 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.MethodsRandomized 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.DiscussionThis 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 registrationClinicalTrails.gov NCT02687516. Registered 16th of February, 2016Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-3755-9) contains supplementary material, which is available to authorized users.

Highlights

The purpose of the Family-based behavioral treatment of childhood obesity (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 given to children and adolescents with obesity in a routine clinical practice
A recent study [9] with 2.3 million participants between the ages of 16 and 19 years found that a graded increased risk for cardiovascular and all-cause mortality during 40 years of follow-up started among participants with a body mass index (BMI; kg/m2) currently accepted within the normal range
The aim of this paper is to describe and explain the design and evaluation of the Family-based behavioral treatment of childhood obesity (FABO)−study targeting children and adolescents with obesity and their families

Summary

Introduction

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. There has been a global increase in the prevalence and severity of overweight and obesity amongst both adults and children [1, 2]. A recent study [9] with 2.3 million participants between the ages of 16 and 19 years found that a graded increased risk for cardiovascular and all-cause mortality during 40 years of follow-up started among participants with a body mass index (BMI; kg/m2) currently accepted within the normal range (from 50th to 74th percentiles). There is substantial evidence indicating that it is difficult to get more than modest weight loss when treating adolescents with severe obesity [13, 14]

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