Clinical trial NCT03060213: Fun For Wellness: Online Well-Being Promotion Intervention in a Patient Sample
Official title: Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: A Randomized Controlled Trial in a Community-Based Patient Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Promotion
Keywords: Well-Being
e-Health
Randomized Controlled Trial
Self-Efficacy
Interpersonal well-being
Community well-being
Occupational well-being
Physical well-being
Psychological well-being
Economic well-being
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will be compared to a usual care (UC) control group on outcomes of overall subjective well-being, domain-specific well-being, health-related quality of life, and well-being self-efficacy. The intervention group will participate in online activities for 30 days while UC control group participants will be asked to conduct their lives as usual for the same 30 day period. Both groups will complete assessments during this time period. The UC group will be given access to the intervention for 30 days after all study participants have completed the three survey battery administrations.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Hypothesis 2: Self-efficacy effect: The online well-being program will be more effective than the usual care condition in improving I COPPE well-being self-efficacy.

Hypothesis 3: Mediating effect: The effect of the online well-being program on- 1) overall well-being, 2) domain well-being and, 3) health related quality of life will be partially mediated by improvements in I COPPE well-being self-efficacy over time.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in overall well-being I COPPE Scale scores between baseline and time 3.
timeFrame: baseline (time 1), 30 days (time 2), and 60 days (time 3)
measure: Change in interpersonal well-being I COPPE Scale score between baseline and time 3.
timeFrame: baseline (time 1), 30 days (time 2), and 60 days (time 3)
measure: Change in community well-being I COPPE Scale score between baseline and time 3.
timeFrame: baseline (time 1), 30 days (time 2), and 60 days (time 3)
measure: Change in occupational well-being I COPPE Scale score between baseline and time 3.
timeFrame: baseline (time 1), 30 days (time 2), and 60 days (time 3)
measure: Change in physical well-being I COPPE Scale score between baseline and time 3.
timeFrame: baseline (time 1), 30 days (time 2), and 60 days (time 3)
measure: Change in psychological well-being I COPPE Scale score between baseline and time 3.
timeFrame: baseline (time 1), 30 days (time 2), and 60 days (time 3)
measure: Change in economic well-being I COPPE Scale score between baseline and time 3.
timeFrame: baseline (time 1), 30 days (time 2), and 60 days (time 3)
Secondary outcomes:
measure: Change in health-related quality of life (HRQOL)-physical component score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: Change in self-efficacy in well-being (SEWB) overall domain score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: Change in self-efficacy in well-being (SEWB) interpersonal domain score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: Change in self-efficacy in well-being (SEWB) community domain score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: Change in self-efficacy in well-being (SEWB) occupational domain score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: Change in self-efficacy in well-being (SEWB) physical domain score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: Change in self-efficacy in well-being (SEWB) psychological domain score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: Change in self-efficacy in well-being (SEWB) economic domain score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
measure: 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.
timeFrame: baseline, 30 days, and 60 days
Other outcomes:
measure: Change in I COPPE actions total score between baseline and time 3.
timeFrame: baseline, 30 days, and 60 days
measure: Strength of the relationship between self-efficacy to comply scores and complier average causal effect (CACE) values over time.
timeFrame: baseline, 30 days, and 60 days
Locations:
city: Miami
country: United States
facility: UHealth Lennar Medical Center
state: Florida
Study officials:
affiliation: Dean, School of Education and Human Development; Professor; Vice Provost, Office of Institutional Culture
name: Isaac Prilleltensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: