Fun For Wellness: Online Well-Being Promotion Intervention in a Patient Sample

NCT ID: NCT03060213

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-06
• Study Completion Date: 2017-07-15

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.

Conditions

Health Promotion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fun For Wellness (FFW)

Intervention participants will: 1) watch original videos with vignettes performed by professional actors; 2) read and/or watch mini-lectures that teach skills for behavior change; 3) engage in self-reflection exercises, 4) play original interactive games related to vignettes and mini-lectures; 5) interact with other FFW users via chat room functions and; 6) watch funny narrated video clips about well-being.

Group Type: EXPERIMENTAL

Fun For Wellness (FFW)

Intervention Type: BEHAVIORAL

FFW consists of videos, games, and content teaching 14 skills to support seven drivers of change that promote well-being in I COPPE domains. The drivers form the acronym BET I CAN, which stands for: Behaviors, Emotions, Thoughts, Interactions, Context, Awareness, and Next Steps. B teaches basics of habit formation, including antecedents, behaviors, and consequences and techniques like goal setting, behavior tracking and rewards. E teaches how to build positive emotions and cope with negative ones. T teaches lessons from cognitive behavioral therapy. I builds communication skills such as empathy, listening and assertiveness. C teaches how to create healthier environmental contexts. A aims to increase insight. N emphasizes the need to make plans and anticipate barriers.

Usual Care (UC)

The Usual Care (UC) group will conduct their lives as usual during the 30 day intervention period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fun For Wellness (FFW)

FFW consists of videos, games, and content teaching 14 skills to support seven drivers of change that promote well-being in I COPPE domains. The drivers form the acronym BET I CAN, which stands for: Behaviors, Emotions, Thoughts, Interactions, Context, Awareness, and Next Steps. B teaches basics of habit formation, including antecedents, behaviors, and consequences and techniques like goal setting, behavior tracking and rewards. E teaches how to build positive emotions and cope with negative ones. T teaches lessons from cognitive behavioral therapy. I builds communication skills such as empathy, listening and assertiveness. C teaches how to create healthier environmental contexts. A aims to increase insight. N emphasizes the need to make plans and anticipate barriers.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Isaac Prilleltensky

Dean of the School of Education and Human Development; Professor; Vice Provost for Institutional Culture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isaac Prilleltensky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dean, School of Education and Human Development; Professor; Vice Provost, Office of Institutional Culture

Locations

UHealth Lennar Medical Center

Miami, Florida, United States

Countries

United States

Other Identifiers

20170001

Identifier Type: -

Identifier Source: org_study_id