Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: A Randomized Controlled Trial in a Community-Based Patient Sample
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in community well-being I COPPE Scale score between baseline and time 3.
研究概览
简要总结
Subjective well-being refers to people's level of satisfaction with life as a whole and with multiple dimensions within it. Interventions that promote subjective well-being are important because there is evidence that physical health, mental health, substance use and health care costs may be related to subjective well-being. This randomized controlled trial will evaluate an online intervention, named Fun For Wellness (FFW), designed to promote well-being skills and self-efficacy in six domains of life: interpersonal, community, occupational, physical, psychological, and economic (I COPPE). The Usual Care (UC) control group will be wait-listed. Five hundred (500) community-based adult patient participants will be enrolled. We hypothesize that compared to the UC group, intervention group participants will show greater improvement in their overall subjective well-being, domain-specific well-being, health-related quality of life, and well-being self-efficacy.
详细描述
Subjective well-being is a positive state affairs in six domains of life: interpersonal, community, occupational, physical, psychological, and economic (I COPPE). The purpose of the study is to evaluate the effectiveness, feasibility, and acceptability of an online intervention named Fun For Wellness (FFW), designed to promote skills and self-efficacy in the multidimensional I COPPE domains of life.
In designing the program we considered the pressing societal need to promote universal health and well-being and prevent stress, illness and disease. Preventable conditions related to lifestyle such as obesity and stress afflict millions of people. Therefore, we saw a need to develop a universal tool for the adult population who would be comfortable with the online platform of FFW. Universal programs have been shown to be effective, for example, in reducing mental health problems in college students.
While face-to-face interventions are effective in preventing serious conditions, they are very labor intensive and limited in reach. The ability to prevent adverse conditions and to enhance healthy behaviors through online interventions creates several opportunities: accessibility, scalability, interactivity, affordability, and fidelity of implementation. A randomized controlled trial of the FFW intervention in an employee sample, found initial evidence for the effectiveness of the FFW intervention. Participants who complied with the FFW intervention had significantly higher subjective well-being, as compared to compliers in the Usual Care group, in multiple I COPPE domains.
For the current study, well-being and self-efficacy measures will be administered at baseline (T1), 30 days-post baseline (T2) and 60 days -post baseline (T3). A maximum of 500 patients will be enrolled. Recruitment will take place on-site through IRB approved study flyers at a community medical center. All other study activities will take place entirely online at a secure website.
Hypothesis 1: Outcome effects: The online well-being program will be more effective than the usual care condition in improving: 1) overall well-being 2) domain well-being, and 3) health related quality of life (HRQOL) over time.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants who have completed the full online T1 battery will be randomly assigned in real-time by the computer to either the intervention condition or the UC control condition. Randomization, group assignment, and assessments will be conducted solely by the computer program, so researchers will be blind to participant randomization, group assignment, and participant group identity during assessment times. With regard to group size and power, experience from our prior efficacy study of FFW indicates that for the current study, the computer program will use a 2:1 randomization algorithm so that there are twice as many FFW intervention participants as UC control participants.
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
- •Individual is at least 18 years old
- •Individual is a current patient at University of Miami's UHealth Lennar Medical Center
- •Individual is not now, nor has ever participated in activities of the Fun For Wellness online program
排除标准
- •Individual less than 18 years old
- •Individuals who are not current a patient at University of Miami's UHealth Lennar Medical Center
- •Individual is now, or has ever participated in activities of the Fun For Wellness online program
结局指标
主要结局
Change in community well-being I COPPE Scale score between baseline and time 3.
时间窗: baseline (time 1), 30 days (time 2), and 60 days (time 3)
The investigators will assess the efficacy of FFW on improving community well-being as measured by the I COPPE Scale community well-being score.
Change in occupational well-being I COPPE Scale score between baseline and time 3.
时间窗: baseline (time 1), 30 days (time 2), and 60 days (time 3)
The investigators will assess the efficacy of FFW on improving occupational well-being as measured by the I COPPE Scale occupational well-being score.
Change in psychological well-being I COPPE Scale score between baseline and time 3.
时间窗: baseline (time 1), 30 days (time 2), and 60 days (time 3)
The investigators will assess the efficacy of FFW on improving psychological well-being as measured by the I COPPE Scale psychological well-being score.
Change in interpersonal well-being I COPPE Scale score between baseline and time 3.
时间窗: baseline (time 1), 30 days (time 2), and 60 days (time 3)
The investigators will assess the efficacy of FFW on improving interpersonal well-being as measured by the I COPPE Scale interpersonal well-being score
Change in economic well-being I COPPE Scale score between baseline and time 3.
时间窗: baseline (time 1), 30 days (time 2), and 60 days (time 3)
The investigators will assess the efficacy of FFW on improving economic well-being as measured by the I COPPE Scale economic well-being score.
Change in overall well-being I COPPE Scale scores between baseline and time 3.
时间窗: baseline (time 1), 30 days (time 2), and 60 days (time 3)
The primary objective of this study is to determine if FFW improves well-being as measured by change in I COPPE Scale domain scores after 60 days compared to usual care for patient well-being at the University of Miami's UHealth Lennar Medical Center. The investigators will assess the efficacy of FFW on I COPPE overall well-being as measured by the I COPPE Scale overall well-being score.
Change in physical well-being I COPPE Scale score between baseline and time 3.
时间窗: baseline (time 1), 30 days (time 2), and 60 days (time 3)
The investigators will assess the efficacy of FFW on improving physical well-being as measured by the I COPPE Scale physical well-being score.
次要结局
- Change in self-efficacy in well-being (SEWB) occupational domain score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) community score between baseline and time 3 will mediate the relationship between the effect of FFW and change in I COPPE community well-being scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) interpersonal score between baseline and time 3 will mediate the relationship between the effect of FFW and change in I COPPE interpersonal well-being scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in health-related quality of life (HRQOL)-physical component score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being (SEWB) interpersonal domain score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being (SEWB) psychological domain score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) physical score between baseline and time 3 will mediate the relationship between the effect of FFW and change in I COPPE physical well-being scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) economic score between baseline and time 3 will mediate the relationship between the effect of FFW and change in I COPPE economic well-being scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) community score between baseline and time 3 will mediate the relationship between the effect of FFW and change on HRQOL physical component (PC) scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) economic score between baseline and time 3 will mediate the relationship between the effect of FFW and change on HRQOL physical component (PC) scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being (SEWB) overall domain score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being (SEWB) community domain score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being (SEWB) physical domain score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being (SEWB) economic domain score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) overall score between baseline and time 3 will mediate the relationship between the effect of FFW and change in I COPPE overall well-being scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) physical score between baseline and time 3 will mediate the relationship between the effect of FFW and change on HRQOL physical component (PC) scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) psychological score between baseline and time 3 will mediate the relationship between the effect of FFW and change on HRQOL physical component (PC) scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) occupational score between baseline and time 3 will mediate the relationship between the effect of FFW and change in I COPPE occupational well-being scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) overall score between baseline and time 3 will mediate the relationship between the effect of FFW and change on Health Related Quality Of Life (HRQOL) physical (PC) score between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) interpersonal score between baseline and time 3 will mediate the relationship between the effect of FFW and change on HRQOL physical component (PC) scores between baseline and time 3.(baseline, 30 days, and 60 days)
- Change in self-efficacy in well-being domains (SEWB) occupational score between baseline and time 3 will mediate the relationship between the effect of FFW and change on HRQOL physical component (PC) scores between baseline and time 3.(baseline, 30 days, and 60 days)
研究者
Isaac Prilleltensky
Dean of the School of Education and Human Development; Professor; Vice Provost for Institutional Culture
University of Miami