Design of the FRESH-teen study: A randomized controlled trial evaluating an adapted emotion regulation weight loss program for adolescents with overweight or obesity and their parent.
Kerri N BoutelleMichael A ManzanoEllen K PasqualeRebecca S BernardDavid R StrongKyung E RheeDawn M EichenScott EngelAlec MillerCarol B PetersonPublished in: Contemporary clinical trials (2024)
Overweight and obesity affect >40% of adolescents. Family-based behavioral treatment (FBT) is the most efficacious behavioral treatment for weight management among youth and consists of nutrition and physical activity education, behavior change skills, and parent skills training. However, the efficacy of FBT decreases for youth as they get older. Increased emotional lability and limited emotion regulation skills may contribute to the reduced efficacy of FBT for adolescents. To date, there are no treatments for overweight or obesity specifically adapted for the needs of adolescents. We developed a treatment that integrates components from Dialectical Behavior Therapy and Emotion Focused Therapy with FBT (FBT+ER or FBT-ER) to address the specific needs of adolescents. The current study randomized 166 adolescents (BMI = 32.8; 14.3 years; 57% female; 32% Hispanic, 50% Non-Hispanic White, 18% Non-Hispanic and Non-White) and one of their parents (BMI = 32.9; 45.3 years; 85% female; 27% Hispanic, 57% Non-Hispanic White, 16% Non-Hispanic and Non-White) to 6 months of either standard FBT or FBT+ at 2 sites. Assessments were conducted at baseline, mid-treatment (month 3), post-treatment (month 6), 6-month follow-up (month 12) and 12-month follow-up (month 18). Primary outcomes are adolescent weight (BMIz/%BMIp95), emotion regulation skills, and emotional eating behaviors. Given the public health concern of adolescent obesity, FBT+ could prove extremely useful to provide more targeted and effective intervention for adolescents with overweight or obesity. CLINICAL TRIALS: # NCT03674944.
Keyphrases
- physical activity
- weight loss
- young adults
- weight gain
- bariatric surgery
- body mass index
- public health
- type diabetes
- metabolic syndrome
- clinical trial
- insulin resistance
- mental health
- roux en y gastric bypass
- randomized controlled trial
- mesenchymal stem cells
- open label
- gastric bypass
- combination therapy
- sleep quality
- depressive symptoms
- bone marrow
- drug delivery
- quality improvement
- childhood cancer
- body weight
- global health
- obese patients
- study protocol
- endoplasmic reticulum
- cancer therapy