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临床试验/NCT02731768
NCT02731768已完成不适用

Using Technology to Enhance Social Support for Weight Loss in Adults: The NETworks (Nutrition, Exercise, and Technology) Pilot Randomized Controlled Trial

University of South Carolina2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年1月最近更新:
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
36
试验地点
2
主要终点
Change from Baseline Body Weight at 4 and 12 months

研究概览

简要总结

The purpose of this study is to evaluate whether a social support-enhanced, technology-based, behavioral weight control intervention can improve weight loss over existing best practices.

详细描述

This 4-month randomized controlled trial is designed to investigate the short-term efficacy and feasibility of a novel, social support-enhanced behavioral weight control intervention. Participants will be recruited via email listservs, fliers, and word of mouth. They will be randomized to a standard behavioral weight control treatment (SBT) or a social support-enhanced behavioral weight control treatment which receives the same intervention as SBT plus social support resources (specifically, additional self-monitoring technologies) for weight loss.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) between 25 kg/m2 and 55 kg/m2
  • Age 18 years or older
  • Access to a computer with an Internet connection
  • Smartphone ownership (Android or iOS)
  • Willing to be randomized to either one of the two study groups
  • Only one member of the same household eligible to participate

排除标准

  • Currently lactating, pregnant, or planning to become pregnant during the length of the study
  • Been diagnosed with type 1 or type 2 diabetes
  • Medical or physical contraindications or limitations for engaging in physical activity
  • History of major medical or psychiatric conditions
  • Recent changes in medication known to affect weight
  • Schedule that would prohibit or restrict attendance at a designated time for weekly in- person group meetings
  • Currently participating in a weight management program
  • Currently on medication that might affect weight loss

研究组 & 干预措施

Standard

Active Comparator

Participants will receive an evidence-based behavioral weight control program focused on physical activity and reducing caloric intake. They will be provided with a Fitbit Zip and digital body weight scale for self-monitoring of physical activity and body weight, respectively. They will track caloric intake via the MyFitnessPal smartphone application. They will have access to a study website and attend weekly, in-person group counseling sessions.

干预措施: Standard (Behavioral)

Standard

Active Comparator

Participants will receive an evidence-based behavioral weight control program focused on physical activity and reducing caloric intake. They will be provided with a Fitbit Zip and digital body weight scale for self-monitoring of physical activity and body weight, respectively. They will track caloric intake via the MyFitnessPal smartphone application. They will have access to a study website and attend weekly, in-person group counseling sessions.

干预措施: Fitbit Zip (Device)

Standard

Active Comparator

Participants will receive an evidence-based behavioral weight control program focused on physical activity and reducing caloric intake. They will be provided with a Fitbit Zip and digital body weight scale for self-monitoring of physical activity and body weight, respectively. They will track caloric intake via the MyFitnessPal smartphone application. They will have access to a study website and attend weekly, in-person group counseling sessions.

干预措施: Digital body weight scale (Device)

Social support-enhanced

Experimental

Participants will receive the same intervention components as the Standard group, as well as two extra Fitbit Zips and digital body weight scales to share with up to two persons in their social circle who will be invited to serve as their support partners.

干预措施: Digital body weight scale (Device)

Social support-enhanced

Experimental

Participants will receive the same intervention components as the Standard group, as well as two extra Fitbit Zips and digital body weight scales to share with up to two persons in their social circle who will be invited to serve as their support partners.

干预措施: Social support-enhanced (Behavioral)

Social support-enhanced

Experimental

Participants will receive the same intervention components as the Standard group, as well as two extra Fitbit Zips and digital body weight scales to share with up to two persons in their social circle who will be invited to serve as their support partners.

干预措施: Fitbit Zip (Device)

结局指标

主要结局

Change from Baseline Body Weight at 4 and 12 months

时间窗: 0, 4, and 12 months

次要结局

  • Change from 2-month Autonomy Support (Important Other Climate Questionnaire) at 4 and 12 months(2, 4, and 12 months)
  • Change from Baseline Motivation for Weight Control (Treatment Self-regulation Questionnaire) at 4 months(0 and 4 months)
  • Change from Baseline Average Daily Step Counts measured via BodyMedia SenseWear armband (one-week time period) at 4 and 12 months(0, 4, and 12 months)
  • Change from Baseline in Social Support for Weight Loss (Social Support for Weight Loss Scale) at 4 and 12 months(0, 4, and 12 months)
  • Change from Baseline Appropriate and Inappropriate Weight Control Practices (Weight Control Practices Checklist) at 4 and 12 months(0, 4, and 12 months)
  • Change from Baseline in Social Support for Exercise (Social Support for Exercise Scale) at 4 and 12 months(0, 4, and 12 months)
  • Change from Baseline in Social Support for Eating Habits (Social Support for Eating Habits Scale) at 4 and 12 months(0, 4, and 12 months)
  • Change from Baseline Social Support Through Technology (2-item questionnaire - level of support and type of support through technology) at 4 and 12 months(0, 4, and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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