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

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Kerri N. Boutelle , Michael A. Manzano , Ellen K. Pasquale , Rebecca S. Bernard , David R. Strong , Kyung E. Rhee , Dawn M. Eichen , Scott Engel , Alec Miller , Carol B. Peterson
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引用次数: 0

Abstract

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

FRESH-teen 研究的设计:一项随机对照试验,评估针对超重或肥胖青少年及其父母的情绪调节减肥计划
40%的青少年受到超重和肥胖的影响。以家庭为基础的行为治疗(FBT)是对青少年体重管理最有效的行为治疗方法,包括营养和体育锻炼教育、行为改变技能和家长技能培训。然而,随着年龄的增长,家庭行为疗法对青少年的疗效会逐渐下降。情绪不稳定性的增加和情绪调节技能的限制可能会导致青少年的 FBT 疗效降低。迄今为止,还没有专门针对青少年超重或肥胖症的治疗方法。我们开发了一种治疗方法,将辩证行为疗法和情绪集中疗法的组成部分与FBT(FBT+ER或FBT-ER)相结合,以满足青少年的特殊需求。本研究将 166 名青少年(体重指数 = 32.8;14.3 岁;57% 女性;32% 西班牙裔、50% 非西班牙裔白人、18% 非西班牙裔和非白人)及其父母中的一人(体重指数 = 32.9;45.3 岁;85% 女性;27% 西班牙裔、57% 非西班牙裔白人、16% 非西班牙裔和非白人)随机分配到两个地点,接受为期 6 个月的标准 FBT 或 FBT+。评估在基线、治疗中期(第 3 个月)、治疗后(第 6 个月)、6 个月随访(第 12 个月)和 12 个月随访(第 18 个月)时进行。主要结果是青少年体重(BMIz/%BMIp95)、情绪调节技能和情绪化饮食行为。鉴于青少年肥胖症引起的公共卫生问题,FBT+ 将被证明非常有用,可为超重或肥胖的青少年提供更有针对性和更有效的干预。
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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