跳至主要内容
临床试验/NCT05176847
NCT05176847已完成不适用

Increasing Social Support for Weight Loss Through the Use of Social Gaming and Points: The Mobile Intervention for Food and Exercise (mLIFE) Study

University of South Carolina1 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
243
试验地点
1
主要终点
Change in body weight

研究概览

简要总结

The goal of the study is to examine long term sustained weight loss digital intervention in a diverse cohort of adults with overweight/obesity. The intervention includes social gaming (using game-like elements in nongame contexts to promote supportive social interactions and openness to positive behavioral influences) to reward behaviors, such as self-monitoring and social support.

Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

  1. Determine if the intervention plus gaming produces significantly more weight loss at 12 months than the same intervention without gaming among 240 adults with overweight or obesity and ≥3 T2DM risk factors.
  2. Examine the differences in social support provision and receipt between groups at 12 months.

详细描述

This is a 1-year behavioral intervention with standardized behavioral content that reinforces self-monitoring behavior delivered via twice-weekly podcasts, tips of the day, weight, physical activity and diet daily tracking. The mLife App will also encourage and facilitate social support among participants (to both groups).

Participants will be randomized to one of two groups: 1) a gamified mLIFE app (n=120) or 2) regular mLIFE app (n=120). Participants will attend a study orientation, complete all baseline measures, be randomized, and then attend a training session for their group. In addition, participants will complete assessment at 6 and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be between 18-65 years old
  • ≥3 T2DM risk factors (as defined by the American Diabetes Association)
  • Own and use a smartphone with a data plan
  • BMI must be between 25-49.9 kg/m2
  • Must be willing to reduce caloric intake and increase physical activity
  • Not currently participating in a weight loss study in a weight loss program
  • Be free of major health or psychiatric diseases, drug or alcohol dependency.
  • No current use of medications that may impact blood glucose

排除标准

  • Over the age of 65 years old
  • Currently participating in a weight loss program
  • Has lost more than 10 pounds in the past 6 months
  • Diagnosed with type 2 diabetes

结局指标

主要结局

Change in body weight

时间窗: 12 months

Change in body weight from baseline to 12 months as assessed digitally

Change in Body Weight

时间窗: 12 months

Difference in body weight between follow-up and baseline (follow-up - baseline); positive values indicate weight gain.

次要结局

  • Change in Kcals consumed a day(12 months)
  • Change in minutes a week of moderate to vigorous physical activity (MVPA)(12 months)
  • Change in Energy Intake(12 months)
  • Change in Weekly Moderate to Vigorous Physical Activity (MVPA)(12 months)

研究者

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

Brie Turner-McGrievy

Associate Professor

University of South Carolina

研究点 (1)

Loading locations...

相似试验