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临床试验/NCT02677792
NCT02677792已完成不适用

Wellness and Weight Family Group Project

University of Mississippi Medical Center2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in Child Weight Status (BMIz)

研究概览

简要总结

The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit
  • child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender)
  • child or adolescent is accompanied by a parent or legal guardian
  • participating child and parent speak and read English
  • family agrees to attend group meetings at a medical clinic over a 3 month period

排除标准

  • participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma)
  • child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)
  • child or parent, according to parent report, in commercial weight loss program
  • child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report
  • parent and child do not speak and read English

结局指标

主要结局

Change in Child Weight Status (BMIz)

时间窗: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

BMIz calculated from measured child height and weight

次要结局

  • Change in Child A1C Values(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Child Glucose Values(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Child Dietary Intake Total kcals from 24-hour dietary recall(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Parent Dietary Intake Total kcals from 24-hour dietary recall(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Parent Weight(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))

研究者

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

Crystal Stack Lim

Assistant Professor

University of Mississippi Medical Center

研究点 (2)

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