Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention: INSTANT Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Weight (kg)
研究概览
简要总结
Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in a community-based weight loss program centered in a metropolitan area of a Midwest state. Based on this criteria, we will anticipate participants are greater than 18 years of age, and have obesity.
- •Must own a smart phone and be willing to download the mobile application to receive text messages
排除标准
- •Report a current medical condition or treatment for a medical condition that could affect body weight.
- •Current psychological condition (including clinically diagnosed depression) that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
- •Is not fluent in writing or speaking the English language.
- •Mobility limitations so they are unable to perform physical activity.
- •Family member currently enrolled in the study or has a family member that previously participated in the study.
结局指标
主要结局
Weight (kg)
时间窗: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Weight will be measured using a digital scale in kg to the nearest 0.1 kg.
Physical Activity
时间窗: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Physical activity will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive days. Accelerometer will only be removed for water-based activities.
Sleep
时间窗: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Sleep will be device-measured using an ActiGraph accelerometer. Participants will wear the accelerometer on their wrist for 14 consecutive nights.
Stress-related Concepts (EMA)
时间窗: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Stress-related concepts are measured by surveys of daily coping ability, stress, and affect assessed by Ecological Momentary Assessments (EMA). For daily coping, participants will be asked about their ability to cope with stress, on a scale from 0-10 with 10 indicating completely able to cope. For stress participants will be asked about their current stress level, on a scale from 0-10 with 10 indicating the highest stress. Affect will be assessed through 5 questions related to their current feeling of happiness, frustration, stress, anger, sadness, and calm/relaxed.
次要结局
- Cortisol (mg/mL)(0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks)
研究者
Chelsea L. Kracht, PhD
Assistant Professor
University of Kansas Medical Center