title: Study Protocol: A randomized controlled trial evaluating the effect of family-based behavioral treatment of childhood and adolescent obesity-The FABO-study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrails.gov NCT02687516 . Registered 16th of February, 2016.
authors: Department of Medicine, the Obesity Outpatient Clinic, Haukeland University Hospital, N-5021, Bergen, Norway. Hanna.Flekoy.Skjakodegard@hib.no.|Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway. Hanna.Flekoy.Skjakodegard@hib.no.
authors: Hanna F
authors: HF
authors: Skjåkødegård
authors: Department of Clinical Psychology, University of Bergen, Bergen, Norway.
authors: Yngvild S
authors: YS
authors: Danielsen
authors: Department of Medicine, the Obesity Outpatient Clinic, Haukeland University Hospital, N-5021, Bergen, Norway.
authors: Mette
authors: M
authors: Morken
authors: Department of Medicine, the Obesity Outpatient Clinic, Haukeland University Hospital, N-5021, Bergen, Norway.
authors: Sara-Rebekka F
authors: SF
authors: Linde
authors: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors: Rachel P
authors: RP
authors: Kolko
authors: Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.|Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.|Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, USA.|Department of Psychology, Washington University School of Medicine, St. Louis, MO, USA.
authors: Katherine N
authors: KN
authors: Balantekin
authors: Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.|Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.|Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, USA.|Department of Psychology, Washington University School of Medicine, St. Louis, MO, USA.
authors: Denise E
authors: DE
authors: Wilfley
authors: Department of Medicine, the Obesity Outpatient Clinic, Haukeland University Hospital, N-5021, Bergen, Norway.|Department of Clinical Science, University of Bergen, Bergen, Norway.
authors: Pétur B
authors: PB
authors: Júlíusson
mesh_terms: D000293:Adolescent; D001823:Body Composition; D015992:Body Mass Index; D002648:Child; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003376:Counseling / Q000379:methods*; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D009664:Norway; D009765:Obesity / Q000628:therapy; D050177:Overweight / Q000628:therapy; D010287:Parent-Child Relations; D016487:Parenting; D063766:Pediatric Obesity / Q000628:therapy*; D012944:Social Support; D011795:Surveys and Questionnaires; D055105:Waist Circumference
keywords: Childhood obesity; Family-based behavioral treatment; Randomized controlled trial