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临床试验/NCT02192905
NCT02192905已完成不适用

Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

University of Connecticut1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年12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
45
试验地点
1
主要终点
Feasibility (Total Uses)

研究概览

简要总结

The purpose of this research was to develop and test the feasibility of Habit, a weight loss mobile application that was designed to coach patients through their weight loss challenges. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Smart Coach mobile application when paired with a shortened online-delivered (8-week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. Post-intervention focus groups discussed the feasibility and acceptability of the intervention. The investigators also performed exploratory analyses comparing conditions on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial.

详细描述

The investigators developed and tested the feasibility of Habit, a weight loss mobile app that includes common features such as self-monitoring, goal setting, and a social network, but even more importantly, an avatar-facilitated, idiographic problem solving feature that processes information intelligently to help patients identify solutions to their weight loss problems. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Habit mobile application when paired with a shortened (8 week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. The investigators also performed analyses on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial. Data will support an efficacy trial of a Habit-assisted brief behavioral weight loss intervention relative to a brief behavioral weight loss intervention alone with 1 year follow-up. The investigators overarching goal is to develop mobile technology that reduces the intensity of lifestyle interventions as far as possible while preserving weight loss outcomes, to ultimately broaden reach.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion: Participants must 1) have a BMI between 30 and 45, 2) currently uses a smartphone with Android software, 3) have connectivity to the internet at home and work, 4) have PCP written clearance, and 5) age 18 or older.

排除标准

  • •BMI <30 and >45
  • •Does not currently use a smart phone with Android software version 4.4 or later
  • •Does not use a smartphone supported by the app (will assess model and type of phone for each participant)
  • •Does not have connectivity to the internet at home and work; or wifi access at home
  • •Does not use smart phone regularly throughout the day
  • •Has not used Android smartphone for at least a year
  • •Has not used a weight loss mobile app in the last 6 months
  • •Does not have a Facebook account, uses it infrequently, or does not actively engage on Facebook
  • •Does not have a gmail account or is unwilling to create one
  • •Does not have PCP written clearance
  • •Bipolar disorder, substance abuse, psychosis, bulimia, or severe depression
  • •Pregnant or lactating
  • •Had bariatric surgery
  • •Medication affecting weight
  • •Adults unwilling to provide consent
  • •Unable to read or understand English
  • •Has type 1 or 2 diabetes
  • •Have concerns about being audiotaped
  • •Unable to walk unaided
  • •Has any medical condition that precludes lifestyle changes

研究组 & 干预措施

Behavioral Weight Loss + Habit

Experimental

Participants will receive 8 week of an online-delivered weight loss intervention adapted from the Diabetes Prevention Program Lifestyle Intervention and will use the Habit mobile app during the study.

干预措施: Diabetes Prevention Program Lifestyle Intervention (Behavioral)

结局指标

主要结局

Feasibility (Total Uses)

时间窗: 8-week follow-up

Mean total uses of the problem solving function of the mobile application

Feasibility (Total Habits Attempted)

时间窗: 8-week follow-up

Total amount of new habits attempted during the study

Feasibility (Recruitment Rates)

时间窗: Baseline

Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)

Feasibility (Retention Rates)

时间窗: 8-weeks

Total attendance at groups and total withdrawn from the study

次要结局

  • % Weight Change(16 week follow-up)
  • Problem Solving Inventory(8-week follow-up)
  • Social Problem Solving Inventory(16-week follow-up)
  • % Weight Change(8-week follow-up)

研究者

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

Sherry Pagoto

Professor

University of Connecticut

研究点 (1)

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