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临床试验/NCT01134874
NCT01134874已完成2 期

The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention

John M. Jakicic, PhD1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
weight

研究概览

简要总结

The primary aim of this study is to compare the changes in body weight between a technology-based system, an in-person behavioral weight loss intervention, and a combination of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy overweight and obese adults will be recruited to participate. Assessments will be conducted at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight loss plus technology (SBWL+TECH), and technology alone alone (TECH).

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
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ages of 21-55 years
  • •Body mass index (BMI) between 25-39.9 kg/m2

排除标准

  • •Currently pregnant, pregnant in the last 6 months, or plan on becoming pregnant in the next 6 months.
  • •Currently participating in regular exercise for over 60 minutes/week.
  • •Taking any medications that affect body weight or metabolism (e.g. synthroid).
  • •Have any physical limitations that would prevent exercise.
  • •Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
  • •Have a history of myocardial infarction or other heart-related surgeries.
  • •Have a resting systolic blood pressure > 150 mmHg or diastolic blood pressure of > 100 mmHg or currently taking any medications that affect blood pressure or heart rate (e.g. beta blockers).
  • •Currently enrolled in a commercial weight loss program, participating in another weight loss study, or in a weight loss study in the last 12 months.
  • •Have lost > 5% of current body weight in the past 6 months.
  • •Currently being treated for any psychological problems or taking any psychotropic medication.
  • •Currently do not have access to a computer and the Internet that can be used for this study. This requires a PC computer, the ability to load software for the technology system, an existing internet connection provided by the participant, and a dedicated USB port to allow the armband from the technology system to be connected to the computer for the download of information.

研究组 & 干预措施

Standard weight loss intervention

Experimental

干预措施: Standard weight loss intervention (Behavioral)

Standard weight loss intervention plus technology

Experimental

干预措施: Standard weight loss intervention plus technology (Behavioral)

Technology only

Experimental

干预措施: Technology only (Behavioral)

结局指标

主要结局

weight

时间窗: change from 0 to 6 months

Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.

次要结局

  • Weight change(weight at 0, 6, and 12 months)
  • physical activity(0, 6, 12 months)
  • cardiorespiratory fitness(0, 6, 12, months)
  • body composition(0, 6, 12 months)
  • dietary intake(0, 6, 12 months)
  • psychosocial and behavioral measures(0, 6, 12 months)

研究者

发起方
John M. Jakicic, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

John M. Jakicic, PhD

Professor and Chair

University of Pittsburgh

研究点 (1)

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