Treatment of Severely Obese Children and Adolescents Employing "Family-based Behavioral Social Facilitation Treatment"
- Conditions
- Childhood Obesity
- Interventions
- Behavioral: Family-based behavioral social facilitation therapyBehavioral: TAU - Treatment as usual
- Registration Number
- NCT02687516
- Lead Sponsor
- University of Bergen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- The sample will consist of children and adolescents (aged 6-18) referred to the Obesity Outpatient Clinic at Haukeland University Hospital by their general practitioner.
- Criteria for admission to the clinic is an (IOTF) isoBMI of > 35, or a isoBMI > 30 with obesity related co-morbidity.
- Both the child and at least one of the parents agrees to actively participate in the treatment.
- Severe somatic or psychiatric illness that makes adherence to the treatment program impossible.
- Somatic conditions, syndromes or medications that lead to pathological weight gain.
- Participation in other obesity treatment programs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Family-based behavioral social facilitation therapy. Family-based behavioral social facilitation therapy 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 systematically 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. Treatment as usual TAU - Treatment as usual 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 12 months. After 12 months they will be offered treatment by family-based behavioral social facilitation therapy (as in the other treatment arm).
- Primary Outcome Measures
Name Time Method Change in weight status, assessed as BMI, BMI standard deviation scores (SDSs) and percentages above the IOTF cut-off for overweight (%IOTF-25) BMI will be measured at baseline and after 3, 6, 9, 12, 15, 18 and 24 months. Height, weight will be measured by trained assessors at the Obesity Outpatient Clinic.
- Secondary Outcome Measures
Name Time Method Changes in eating habits - Food diary Measurements will be obtained at baseline, 6 months, 12, months, 18 months and 24 months The parents will be instructed to help their children to keep a diary of food and beverage intake for five days including two weekend days. They will use an electronic kitchen scale to weigh the food.
Change in %body fat assessed by Bio-impedance Measurements will be done at baseline, 6 months, 12 months, 18 months and 24 months Bio-impedance measurements of body composition will be conducted at the Obesity Outpatient Clinic using InBody 720.
Changes in psychological parameters - Children's Depression Inventory (CDI) Assessments at baseline, at 6 months, 12 months, 18 months and 24 months Children's Depression Inventory (CDI). CDI is a 27-item self-report test assessing the cognitive, affective and behavioural symptoms of depression in children (7-17 years).
Change in Blood samples and cortisol measurements measurements will be done at baseline, 6 months, 12 months, 18 months and 24 months 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. A bio-bank for the storing and registering of biological materials is approved.
Changes in eating habits - The Dutch Eating Behavior Questionnaire Child version (DEBQ) Assessments at baseline, at 6 months, 12 months, 18 months and 24 months The Dutch Eating Behavior Questionnaire Child version (DEBQ) is a measure of disturbed eating patterns in children and youth (41). DEBQ consists of 3 sub-scales: emotional eating, external eating and restrained eating.
Changes in eating habits - The Youth Eating Disorder Examination-Questionnaire (YEDE-Q) Assessments at baseline, at 6 months, 12 months, 18 months and 24 months The Youth Eating Disorder Examination-Questionnaire (YEDE-Q) is a self-reported measure of eating patterns and eating disorder psychopathology. The YEDE-Q was designed to include measurements of binge eating in youth which have been poorly covered in other self-report measures of eating pathology.
Change in waist circumference Will be measured at baseline and after 3, 6, 9, 12, 15, 18 and 24 months. Will be measured by trained assessors at the Obesity Outpatient Clinic
Change in blood pressure Will be measured at baseline, 6 months, 12 months, 18 months and 24 months Blood pressure will be measured by the pediatrician at the obesity clinic
Changes in physical activity and sleep patterns - Accelerometers Measurements will be made at baseline, 6 months, 12 months, 18 months and 24 months Physical activity and sleep patterns will be measured by using accelerometers. Accelerometers are small devices that register movement. The accelerometers that will be used in this study are worn on the non-dominant wrist and resemble a watch. The accelerometers record all uni-axial movement over 0.05G in one-minute epochs
Change in % body fat assessed by DXA Measurements will be made at baseline, at 6 months, at 12 months, at 18 months and at 24 months. DXA-scans for determining the distribution of fat and muscle tissue will be conducted at the Department of Rheumathology at Haukeland University Hospital.
Changes in psychological parameters - Self-Perception Profile for Children (SPPC). Assessments at baseline, at 6 months, 12 months, 18 months and 24 months Self-Perception Profile for Children (SPPC). SPPC is a self-report measure of self-perception or self-esteem in children aged 8 to 14 years and is widely used for research purposes. The questionnaire includes 36 statements and the children are asked to evaluate to which degree the statement fits their thoughts about themselves.
Changes in psychological parameters - The Child Behavior Checklist (CBCL)/Youth self-report (YSR) Measurements will be obtained at baseline, at 6 months, 12 months, 18 months and 24 months The Child Behavior Checklist (CBCL) is a 138-item rating scale assessing behavioural and emotional symptoms in children that has both a child/youth and parent form.
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Norway