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临床试验/NCT02163252
NCT02163252已完成不适用

Does Early Intervention Improve Weight Loss Outcomes Among Individuals Enrolled in an Internet-based Weight Loss Program?

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Change in weight

研究概览

简要总结

The purpose of this study is to examine whether providing additional intervention support to individuals with lower than expected weight loss within the initial stages of an internet-based behavioral weight loss program improves weight loss outcomes at Week 12, compared to the internet program alone.

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

入选标准

  • •age 18-70 years
  • •BMI >=25 kg/m2
  • •No health problems that make weight loss or unsupervised exercise unsafe
  • •English speaking
  • •Access to computer/internet

排除标准

  • •report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire 62 (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 consent to participate from a health care provider
  • •are currently pregnant or intend to become pregnant in the next 12 months
  • •are planning to move outside of the state within the next 4 months

研究组 & 干预措施

Standard

Active Comparator

A 12-week internet-based weight loss program that involves weekly video lessons, a self-monitoring platform where participants submit their weight, calorie, and activity information, and weekly automated feedback.

干预措施: Standard (Behavioral)

Early intervention

Experimental

Participants randomized to Early Intervention will receive the same internet-based weight loss program compared to the Standard group. In addition, Early Intervention participants achieving less than optimal weight loss following several weeks of treatment will be given the opportunity to come to the Weight Control and Diabetes Research Center for an individual visit. At this visit, an interventionist will discuss with the participant any barriers that he or she may be experiencing and recommend alternate strategies to assist in their weight loss. One such strategy would be to recommend the use of meal replacement products or portion controlled meals. In addition to this one-time visit, the interventionist will follow up with the participant via phone weekly, for 2 weeks following this in-person visit.

干预措施: Early Intervention (Behavioral)

结局指标

主要结局

Change in weight

时间窗: 12-week

次要结局

  • exercise minutes(12 weeks)
  • frequency of self-monitoring(12 weeks)

研究者

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

Jessica Unick

Assistant Professor (Research)

The Miriam Hospital

研究点 (1)

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