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临床试验/NCT03674944
NCT03674944已完成不适用

Targeting Emotional Eating and Weight Loss in Adolescents

University of California, San Diego4 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2019年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
332
试验地点
4
主要终点
Emotional Eating as measured by Emotional Eating Scale for children (EES-C)

研究概览

简要总结

The objective of this proposed study is to collect initial efficacy data on a behavioral weight loss (BWL) program for teens, which also includes emotion regulation strategies (ER), to standard BWL.

详细描述

The study will compare the efficacy of BWL + ER and BWL. Investigators will provide 6 months of treatment (BWL + ER or BWL) and will follow participants at 12-months post-treatment (total time = 18 months). Investigators will recruit adolescents with overweight and obesity and their parents. Dyads will be assessed at 5 timepoints: baseline (2 visits), mid-treatment (1 visit), post-treatment (2 visits), 6-month follow-up (2 visits), and 12-month follow-up (2 visits). Assessments will include the following for the adolescent and parent: anthropometry, emotion regulation, emotional inhibition, emotional eating, and adolescent-parent relationship measures. This program of research has the potential to advance the standard of practice for adolescents who are overweight or obese by providing alternative interventions.

We are currently offering online treatment groups to accommodate the CDC health and safety guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescent age 13-16 years
  • BMI percentile 85%85%-99.9% (adolescent only)
  • Ability to read English at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent)

排除标准

  • Current enrollment in a weight management program (Child and Parent);
  • Medication that is specifically prescribed for weight loss (Child and Parent);
  • Medical or psychiatric condition that may interfere with treatment participation (Child and Parent);
  • Regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (Child and Parent);
  • Current pregnancy or lactating (Child and Parent);
  • Change in psychotropic medication during the previous three months (Child and Parent).

结局指标

主要结局

Emotional Eating as measured by Emotional Eating Scale for children (EES-C)

时间窗: Change from baseline to month 3, 6, 12, and 18.

Adolescent weight loss as measured by BMI, BMIz

时间窗: Change from baseline to month 3, 6, 12, and 18.

Emotion Regulation Skills as measured by Ecological Momentary Assessment using State Difficulties in Emotion Regulation and International Positive and Negative Affect Schedule- Short form

时间窗: Change from baseline to month 3, 6, 12, and 18.

次要结局

  • Parent-adolescent relationship as measured by using: Inventory of Parents and Peer Attachment and Parental bonding assessment(Change from baseline to month 3, 6, 12, and 18.)
  • Parent BMI as measured by height and weight(Change from baseline to month 3, 6, 12, and 18.)
  • Parent emotion regulation measured by Difficulties in Emotion Regulation Scale (DERS)(Change from baseline to month 3, 6, 12, and 18.)
  • Parent emotional eating as measured by Emotional Eating Scale (EES)(Change from baseline to month 3, 6, 12, and 18.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kerri Boutelle

Kerri Boutelle, Ph.D., Professor, Departments of Pediatrics and Psychiatry

University of California, San Diego

研究点 (4)

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