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临床试验/NCT00381160
NCT00381160已完成不适用

Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2006年9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
224
试验地点
2
主要终点
Body mass index (BMI)

研究概览

简要总结

The primary aim of this study is to examine the effect of a multi-component intervention, designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of the intervention differ between adolescents for whom 100% fruit juice vs. other products (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks) constitutes the primary source of sugar from beverages.

详细描述

We are partnering with community organizations (including high schools) in the greater Boston area and a major regional supermarket. Participants will be 240 high school students who drink at least 1 serving of sugar-sweetened beverage (including 100% fruit juices) per day and who have a BMI ≥ 85th percentile. They will be randomly assigned to an intervention or control group. The intervention, of 1-year duration, will target the home/family environment in combination with a behavioral intervention provided during brief check-in visits. The environment will be changed by delivering non-caloric beverages to the homes of adolescents who regularly consume sugar-sweetened beverages. Parents will be counseled by telephone to serve as role models in consuming non-caloric beverages. The behavioral intervention for the adolescents will include didactic and experiential components during the check-in visits. Study outcomes will be assessed at baseline, 1 year (end of intervention period), and 2 years (end of follow-up period).

Additional relevant material based on the original proposal (NIH grant application) is provided below:

Each outcome will be compared between groups using a general linear model, adjusted for baseline covariates that could affect body weight: sex, race, ethnicity (Hispanic vs non-Hispanic), household income, parents' education, BMI, beverage consumption (sugar-sweetened, artificially sweetened, unsweetened), energy intake (total, sugar-sweetened beverages, fruit juice), physical activity level, and daily television viewing. Each covariate will be tested for confounding, mediation, and interaction effects on the primary outcome. Stratum-specific estimates of the group difference will be constructed for any covariates showing significant interaction.

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

  • Enrolled in grade 9 or 10
  • BMI ≥ 85th percentile for age and gender
  • Residing in predominately one household, with access to a working telephone
  • Consumption of 12 fluid ounces sugar-sweetened beverages (including 100% fruit juices) per day

排除标准

  • Sibling participating in the study
  • Intention to change location of residence during the 2 years post-randomization
  • Plans to be away from home for 5 weeks or longer during the study period
  • Physician diagnosis of a major medical illness or eating disorder
  • Chronic use of any medication that may affect body weight or composition
  • Current smoking
  • Physical, mental, or cognitive handicaps that prevent participation

结局指标

主要结局

Body mass index (BMI)

时间窗: Change through 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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