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临床试验/NCT00807560
NCT00807560已完成1 期

Parent-Based Treatment for Pediatric Overweight

Icahn School of Medicine at Mount Sinai4 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
77
试验地点
4
主要终点
BMI Z Score

研究概览

简要总结

The purpose of this study is to determine whether a parent/guardian intervention for adolescent overweight/obesity more effective than a nutritional counseling education curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.

详细描述

Rates of pediatric overweight (PO) among Americans are increasing and associated with significant psychological, social, quality of life, and health related outcomes. Because of the broad mental and physical health implications of PO and the difficulty in sustaining weight loss as an adult, it is of interest to find successful methods of weight loss and/or prevention of weight gain for obese children and adolescents. The family unit is a logical and empirically supported point of intervention for PO. Interventions on this level have shown good long term efficacy in young children, but there is very little research on adolescent family intervention. Within the eating disorder literature, there is growing support for the efficacy of family-based interventions (FBI) for adolescents. Given its trans-developmental applicability, focus on family as the unit of intervention, and utility in creating a healthy eating environment, FBI is a logical candidate for adaptation to intervention for PO and intervention for at-risk for overweight youth (FBI-PO). The core of the current project is to test the feasibility and efficacy of an adapted FBI manual for adolescent overweight and at-risk for overweight in an outpatient eating and weight disorders clinic and compare this modality to a minimal nutritional educational control (NEC) condition.

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
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 13-17
  • Male and female
  • Living with at least one parent or guardian who is willing to participate in treatment
  • A BMI percentile >85% for gender and age (e.g., overweight or at risk for overweight)

排除标准

  • Current psychotic illness
  • Current alcohol/drug dependence
  • Active suicidality
  • Eating disorders (e.g., binge eating disorder)
  • History of bariatric surgery
  • Medication associated with significant weight changes (e.g., antipsychotics)
  • Serious medical or physical conditions resulting in significant weight changes (e.g., pregnancy, genetic disorders).
  • Complications of obesity that contraindicate moderate physical activity (e.g. orthopedic disorders)

结局指标

主要结局

BMI Z Score

时间窗: up to 44 weeks

Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)

次要结局

  • Waist Measurement(up to 44 weeks)
  • Weight(up to 44 weeks)
  • BMI(up to 44 weeks)
  • Percent Completion(at 44 weeks)
  • Hip Measurement(up to 44 weeks)
  • Height(up to 44 weeks)
  • BMI Percentile(up to 44 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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