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临床试验/NCT01724632
NCT01724632已完成不适用

LIVE SMART: Smartphone Intervention for Weight Control

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2012年11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
276
试验地点
1
主要终点
Weight Loss

研究概览

简要总结

The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment). Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and 18 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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Body Mass Index (kg/m2) of 25-
  • •English language fluency
  • •Ability to read at a 6th grade level
  • •Availability to attend weekly treatment sessions in Providence, RI

排除标准

  • •Any heart condition that limits ability to participate in physical activity
  • •Chest Pain
  • •Any cognitive of physical limitation that would preclude use of a smartphone
  • •Serious mental illness
  • •Historical or current eating disorder
  • •Previous or planned bariatric surgery
  • •Use of weight loss medication
  • •Recent pregnancy or a plan to become pregnant in the next 6 months
  • •Participation in a study at the Weight Control and Diabetes Research Center within the last two years
  • •A weight loss of greater than 5% body weight in the last 6 months

研究组 & 干预措施

Group Treatment

Active Comparator

Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants will be weighed individually at the start of each group meeting.

干预措施: Lifestyle Counseling (Behavioral)

Individual Treatment

Active Comparator

Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.

干预措施: Lifestyle Counseling (Behavioral)

Smartphone Treatment

Experimental

Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.

干预措施: Lifestyle Counseling (Behavioral)

结局指标

主要结局

Weight Loss

时间窗: Change from baseline to 18-months.

次要结局

  • Weight-related Behaviors(Change from baseline to 18-months.)

研究者

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

John Graham Thomas

Assistant Professor (Research)

The Miriam Hospital

研究点 (1)

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