RELAX: A Mobile Application Suite Targeting Obesity and Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Usability
研究概览
简要总结
This research is being done is to evaluate the feasibility and acceptability of a novel weight loss mobile app that was designed to be less burdensome than traditional weight loss apps.
详细描述
Obesity and stress are highly comorbid and both increase risk for cardiovascular disease (CVD). Stress is associated with disinhibited eating, junk food consumption and low consumption of produce and whole grains. Both stress and stress-induced eating are not only associated with obesity but also predict worst outcomes in lifestyle interventions. Stress and stress-induced eating should be targeted in interventions to maximize weight loss; however, this makes for a very intensive intervention. Technology could be leveraged to reduce intervention burden.
In this trial investigators propose to compare the feasibility, usability, acceptability, and burden of an traditional weight loss app that includes diet and physical activity self-monitoring features to an app (Slip Buddy) we developed that focuses on self-monitoring of stress eating. With Slip Buddy, the user is just asked to track overeating episodes, indicating when they are triggered by stress. The majority of weight loss apps are burdensome to users by requiring them to self-monitor diet and exercise. They also ignore major barriers to weight loss, such as stress. This work moves the field forward by addressing user burden and an important barrier to 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a BMI of 27-45
- •Currently use an Android smartphone
- •Have cell phone connectivity at home and work
- •Uses a smartphone every day
排除标准
- •Under the age of 18 and over the age of 65;
- •BMI under 27 or over 45;
- •Not interested in losing weight;
- •Does not currently own a smartphone;
- •Smartphone type and/or version not meeting app requirements;
- •No phone connectivity at home and work;
- •Unable to walk unaided for ¼ mile without stopping;
- •Has a condition that precludes dietary changes (i.e. ulcerative colitis, Crohn's disease, active diverticulitis, renal disease);
- •On a medication affecting weight;
- •Type 1 or 2 diabetes;
- •Had gastric bypass surgery;
- •Had or plans to have gastric bypass surgery during the study period;
- •Pregnant/lactating;
- •Has bipolar disorder, substance abuse, bulimia, or severe depression;
- •Lost 5% or more body weight in the last 3 months;
- •Has not experienced emotional eating over the last week;
- •On medication affecting weight;
- •Has concerns about being audiotaped;
- •Prisoner;
- •Unable to provide consent; or
- •Non-English speaking
结局指标
主要结局
Usability
时间窗: 12 weeks
Usability will be assessed using the System Usability Scale (SUS), a 10-item measure with 5-point Likert scale response options (Strongly Agree to Strongly Disagree). Scores are summed (0-40) then converted to a 0-100 scale, with higher scores indicating higher usability. Scores above 58 are considered above average, and scores above 80 are considered to indicate high usability where participants are likely to recommend the product to friends.
Burden
时间窗: 12 weeks
At 12 weeks, participants were asked how burdensome the task of using their assigned application was on a scale of 0-100, 0 being not at all burdensome and 100 being very burdensome.
Percentage of Days App Used Over 12 Weeks
时间窗: 12 weeks
App use was measured for each condition using either backend data from Slip Buddy or reviewing MyFitnessPal entries indicating use over each 24-hour period.
Acceptability
时间窗: 12 weeks
Acceptability was assessed with a single item at 12 weeks assessing perceived helpfulness of the assigned app: "Tracking my diet and exercise with MFP/slips with Slip Buddy was helpful" (responses on a 5-point Likert scale from strongly disagree to strongly agree). Acceptability was indicated by responses of agree or strongly agree.
次要结局
- Percent Weight Change From Baseline to 12-Week Follow-Up(12 weeks)
- Change in Emotional Eating From Baseline to 12-Week Follow-Up(12 weeks)
- Change in Perceived Stress From Baseline to 12-Week Follow-Up(12 weeks)
研究者
Sherry Pagoto
Professor
University of Connecticut