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临床试验/NCT01660685
NCT01660685已完成不适用

Effects of Journaling on Weight Loss

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年8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
100
试验地点
1
主要终点
Weight

研究概览

简要总结

This is a randomized controlled trial with enhanced usual care treatment control. The aim is to determine the effects of journaling and use of resource website on weight loss. There will be two groups of 55 participants each. The intervention condition will be asked to record daily weight, physical activity steps taken and pre-portioned food items and to complete two daily journaling activities. Participants will also receive weekly tracing data, a weekly blog from the principal investigator and have access to a weight control website. The control group will not have access to the tracking, journaling or website for three months. Investigators hypothesize that a website paired with tracking and journaling will be more effective in helping participants lose weight.

详细描述

Participants will call study line given on recruitment materials and be screened over the phone.

Baseline visit:

Individuals who meet the screening criteria will be invited to a one-hour training session about the website and diet plan book. During the training, a coordinator will review the consent form with the participants and ask if they have any questions. The coordinator will take consented individuals' height, weight and blood pressure measurements. Participants will be given a pedometer to use during physical activities and a meal replacement book to use as a resource.

After baseline visit:

All participants will complete surveys online (Demographics, Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire) and be randomized into one of two groups. The intervention group will be asked to record their weight, physical activity steps, pre-portioned food items and journal entries on a daily basis. The control group will be sent an email informing them they will have access to the tracking, journals and website in three months.

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
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •21 to 65 years old
  • •Body mass index between 27 and 45
  • •E-mail and Internet access
  • •Able to read, write, and understand English

排除标准

  • •Weight loss of more than 5% of current body weight in previous 6 months
  • •Participated in weight loss research in previous 6 months
  • •Current use of weight loss medication or program
  • •History of or scheduled weight loss surgery
  • •Heart, liver, or kidney failure
  • •Been told by doctor of heart trouble
  • •Frequent pains in heart and chest
  • •Often feel faint or have spells of severe dizziness
  • •Bone or joint problem that has been or might be aggravated by exercise
  • •Physical reason for not following activity program
  • •History of sever cognitive impairment or major psychiatric illness
  • •Pregnant in previous 6 months, currently or planning to become pregnant in next 3 months
  • •Moving in next 6 months

研究组 & 干预措施

Tracking + Journaling + Website

Experimental

In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.

干预措施: Tracking (Behavioral)

Tracking + Journaling + Website

Experimental

In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.

干预措施: Journaling (Behavioral)

Tracking + Journaling + Website

Experimental

In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.

干预措施: Website (Behavioral)

Tracking + Journaling + Website

Experimental

In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.

干预措施: Enhanced Usual Care (Behavioral)

Enhanced Usual Care

Active Comparator

Participants receive standard care

干预措施: Enhanced Usual Care (Behavioral)

结局指标

主要结局

Weight

时间窗: 3 months

Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.

次要结局

  • Blood Pressure(3 months)
  • Height(3 months)

研究者

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

Christopher Sciamanna, MD, MPH

Chief, Division of General Internal Medicine

Milton S. Hershey Medical Center

研究点 (1)

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