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临床试验/NCT01264393
NCT01264393已完成3 期

Using a State-Wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
500
试验地点
2
主要终点
Weight change from the initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.

研究概览

简要总结

Behavioral weight loss programs can successfully reduce body weight, but these programs are available to limited numbers of overweight and obese individuals. This project evaluates a unique weight loss approach that combines a self-sustaining weight loss campaign (for outreach) with training in behavioral weight loss strategies and strategies to increase accountability (to improve weight loss success). This innovative combination has the potential to be a cost-effective model for disseminating weight control interventions.

详细描述

Participants will be randomly assigned to 1 of 3 treatment arms: Shape Up Rhode Island (SURI; a community-based weight loss campaign), SURI plus an Internet-based behavioral weight loss program (SURI + IBWL), or SURI + IBWL + optional group sessions (SURI + IBWL + Group). Primary outcome is weight loss at 12-weeks.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-70 years
  • Body Mass Index >25 kg/m2
  • Both genders will be recruited; it is estimated that 70% of participants will be women.
  • All ethnic groups will be recruited, with a goal of recruiting 33% minorities (see below for specific recruitment plans)
  • No health problems that make weight loss or unsupervised exercise unsafe
  • English speaking
  • Exclusion criteria:
  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4). Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
  • are currently pregnant or intend to become pregnant in the next 12 months
  • are planning to move outside of the state within the next 12 months
  • have previously participated in the Shape Up Rhode Island 2008 pilot study

排除标准

  • 未提供

结局指标

主要结局

Weight change from the initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.

时间窗: 0 to 3 months

次要结局

  • Weight change from the initial assessment to the 6-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.(0 to 6 months)
  • Weight change from the initial assessment to the 12-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram.(0 to 12-months)

研究者

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

Rena R. Wing

Professor

The Miriam Hospital

研究点 (2)

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