Treatment of Severely Obese Children and Adolescents Employing "Family-based Behavioral Social Facilitation Treatment"
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of Family-based behavioral social facilitation
      therapy (FBSFT) in the treatment of severe obesity in children and adolescents compared to
      treatment as usual (TAU). The FBSFT condition includes 17 weekly family-based treatment
      sessions at the hospital obesity clinic followed by monthly follow-up sessions with their
      local nurse and follow-up sessions at the hospital every third month for 2 years. The
      treatment targets both child and parent life-style; eating habits, physical activity,
      sedentary activity and sleep habits. Behavior modification techniques are employed; such as
      self-monitoring, goal setting, reward systems, problem solving and stimulus control. In
      addition, FBSFT focuses on facilitating lifestyle change across different settings (family,
      friends, school and community) and harnessing social support for healthy habits, which is
      considered important for long-term weight control. The TAU condition involves an assessment
      day with the multidisciplinary team (pediatrician, dietician, physical therapist and
      psychologist) at the hospital obesity clinic. Further a session with the nurse at the
      hospital clinic making a plan for behavioral lifestyle changes followed by monthly follow-up
      sessions with their local nurse and follow-up sessions at the hospital clinic every third
      month for one year.

      SAMPLE AND STUDY DESIGN. The sample will consist of children and adolescents (aged 6-18)
      referred to the Obesity Outpatient Clinic at Haukeland University Hospital. Criteria for
      admission to the clinic is an (IOTF) isoBMI of > 35, or a isoBMI > 30 with obesity related
      co-morbidity. Based on current clinic data, estimations suggest that about 60 families of
      children with severe obesity will be referred to the Obesity Outpatient Clinic every year and
      be offered treatment. Recruitment will start in February 2014 and will continue in 2015 and
      2016. After consenting to participation and completion of the initial assessments the
      families will be randomized to either FBSFT or treatment as usual (TAU). After one year the
      families randomized to TAU will be offered the FBSFT treatment. Measurement points for the
      most important outcome measures will be pre-treatment, post-treatment (at approximately 6
      months), at 12 months, 18 months and 24 months.

      OUTCOME VARIABLES. Anthropometrical measures: Height, weight and waist-circumference,
      DXA-scans and bio-impedance measurements for determining the distribution of fat and muscle
      tissue. Physiological measures: Blood samples will be drawn in the morning after an overnight
      fast. Including measurements of total-cholesterol, HDL, LDL, TG, ASAT, ALAT, gamma-GT,
      bilirubin, creatinin, HbA1c and fasting insulin, c-peptide and glucose, TSH, fT4, CRP.
      Cortisol measurements from saliva and urine. Measurement of bloodpressure. Food records: The
      parents will be instructed to help their children to keep a diary of food and beverage intake
      for five days. They will use an electronic kitchen scale to weigh the food. Physical
      activity: Physical activity and sleep will be measured by using accelerometers. Psychological
      measures: The Child Behavior Checklist (CBCL) is a 138-item rating scale assessing behavioral
      and emotional symptoms in children/youth. Children's Depression Inventory (CDI). CDI is a
      27-item self-report test assessing symptoms of depression in children (7-17 years).
      Self-Perception Profile for Children (SPPC). SPPC is a self-report measure of self-perception
      in children aged 8 to 14 years. The Dutch Eating Behavior Questionnaire Child version (DEBQ)
      is a measure of disturbed eating patterns in children and youth. The Youth Eating Disorder
      Examination-Questionnaire (YEDE-Q) is a self-reported measure of eating patterns and eating
      disorder psychopathology. OTHER MEASUREMENTS INCLUDED. The Parenting Scale (PS) is a 30-item
      questionnaire designed to measure different parental disciplines with children/youth. The
      scores on three sub-scales are calculated - Laxness, Overreactivity and Verbosity. The
      Barriers to Treatment Participation Scale (BTPS). The 44-item scale is developed and
      validated to address drop-out from treatment with out-patient psychological treatment of
      children and adolescents. Child and parent acceptability of the treatment will be measured by
      the FBSFT Acceptability Questionnaire.

      STUDY AIMS:

        1. To evaluate the effect of FBSFT compared to TAU for treatment of severe childhood and
           adolescent obesity in an ordinary health care setting on BMI, BMI SDS, body composition,
           cardio-metabolic health, eating habits, physical activity as well as psychological
           well-being.

        2. To identify predictors of treatment success and treatment drop-out with a focus on
           family variables and mental health.

        3. To evaluate treatment (FBSFT) implementation and treatment acceptability for children,
           parents and health care workers and experienced barriers to treatment, and how these
           factors influence children's and parents' treatment response.
    


Intervention name(s): Family-based behavioral social facilitation therapy; TAU - Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Family-based Behavioral Social Facilitation Treatment (FBSFT) is founded on the principles of standard family-based behavioural therapy for obesity. FBSFT targets life-style behaviors (diet, physical activity and sedentary activity) in a family setting. FBSFT includes some cognitive elements that are considered important in relation to behavioural change for instance problem solving and cognitive restructuring. FBSFT has an intensive treatment phase including weekly family meetings with therapists over 17 consecutive weeks. Further monthly or bi-weekly follow-up sessions with a focus on social facilitation and maintenance of healthy habits are recommended. The dietary guidance of FBSFT is based on the "Traffic light diet" in which foods are organized into GREEN, YELLOW and RED groups. Activity guidance of FBSFT uses the same system: GREEN activities have the highest intensity and should be engaged in most often, YELLOW activities sometimes, and RED activities.; This is the default treatment at the obesity clinic. After initial evaluation by paediatrician, nurse, nutritionist and physiotherapist, a "contract" is written including weight goal, nutritional plan and activity plan. Follow up monthly in primary Health care and every 3rd month at the obesity clinic.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment; Child; Obesity; Behavioral treatment