Program on Work Stress and Health Outcomes in a Heterogeneous University Employee Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ
研究概览
简要总结
The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition.
详细描述
The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition.
Participants assigned to the digital meditation intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. Participants assigned to the healthy eating intervention group will be asked to participate in a 50 minute motivational interviewing counseling session centered around healthy eating behaviors , three 10-minute booster phone calls at weeks 1, 4, and 8, and weekly participation in a digital mindful eating activity.
All study participants will be asked to fill out questionnaires at baseline, week 4, week 8 (post-intervention), and a 4-month follow-up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow-up assessment. Physiological assessments (body composition, blood spot) will be obtained at an in-person clinic visit at baseline and week 8. Fitness, sleep, and mood data will be gathered for seven consecutive days at baseline and week 8.
Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. Adherence in the digital meditation intervention will be tracked remotely. The goal is to recruit up to 165 participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Investigator will be blind to condition throughout data accrual
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
- •You may join if you
- •Have access to a smartphone or computer every day
- •Are fluent in English
- •Are a UCSF employee
- •Report mild to moderate levels of stress (as determined by a Perceived Stress Scale score of 15 or higher)
- •Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and have received a signed and dated copy of the informed consent form
- •Are at least 18 years of age
- •Express a willingness to be randomly assigned into the waitlist group or the intervention groups
- •Report a Body Mass Index (BMI) of 25 kg/m2 or above
排除标准
- •You may not join if you:
- •Are an experienced meditator or have participated in a formal meditation practice in the last 3 months (defined as 3 times per week or more for 10 minutes or more at each practice)
结局指标
主要结局
Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ
时间窗: Baseline to post-intervention, an anticipated average of 8 weeks
The Food Acceptance and Action Questionnaire has a total score scale range of 10 to 60, with higher scores indicating greater acceptance of motivations to eat.
Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale
时间窗: Baseline to post-intervention, an anticipated average of 8 weeks
The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress
次要结局
- Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r)(Baseline to post-intervention, an anticipated average of 8 weeks)
- Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale)(Baseline to post-intervention, an anticipated average of 8 weeks)
- Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale(Baseline to post-intervention, an anticipated average of 8 weeks)
- Change in the Intentional Use of Palatable Food to Cope With Negative Feelings, as Determined by Total Score on the Palatable Eating Motives, Coping Subscale (PEMS)(Baseline to post-intervention, an anticipated average of 8 weeks)