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

Health Promotion Clinical Trial

Official title:

Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: A Randomized Controlled Trial in a Community-Based Patient Sample

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060213
• Other study ID #: 20170001
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: July 15, 2017

Study information

• Verified date: April 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 15, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Promotion

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UHealth Lennar Medical Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in I COPPE actions total score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving I COPPE actions as measured by the I COPPE Actions Scale total score.	baseline, 30 days, and 60 days
Other	Strength of the relationship between self-efficacy to comply scores and complier average causal effect (CACE) values over time.	The investigators will assess the predictive effect of a participant's self-efficacy to comply with the FFW intervention as measured by the Self-Efficacy to Comply Measure score and CACE coefficients.	baseline, 30 days, and 60 days
Primary	Change in overall well-being I COPPE Scale scores between baseline and 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.	baseline (time 1), 30 days (time 2), and 60 days (time 3)
Primary	Change in interpersonal well-being I COPPE Scale score between baseline and 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	baseline (time 1), 30 days (time 2), and 60 days (time 3)
Primary	Change in community well-being I COPPE Scale score between baseline and 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.	baseline (time 1), 30 days (time 2), and 60 days (time 3)
Primary	Change in occupational well-being I COPPE Scale score between baseline and 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.	baseline (time 1), 30 days (time 2), and 60 days (time 3)
Primary	Change in physical well-being I COPPE Scale score between baseline and 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.	baseline (time 1), 30 days (time 2), and 60 days (time 3)
Primary	Change in psychological well-being I COPPE Scale score between baseline and 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.	baseline (time 1), 30 days (time 2), and 60 days (time 3)
Primary	Change in economic well-being I COPPE Scale score between baseline and 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.	baseline (time 1), 30 days (time 2), and 60 days (time 3)
Secondary	Change in health-related quality of life (HRQOL)-physical component score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving HRQOL as measured by the SF-36v2 Health Survey physical component (PC) score.	baseline, 30 days, and 60 days
Secondary	Change in self-efficacy in well-being (SEWB) overall domain score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving SEWB-overall as measured by the Self-Efficacy in Well-Being Domains Scale overall well-being domain score.	baseline, 30 days, and 60 days
Secondary	Change in self-efficacy in well-being (SEWB) interpersonal domain score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving SEWB-interpersonal as measured by the Self-Efficacy in Well-Being Domains Scale interpersonal well-being domain score.	baseline, 30 days, and 60 days
Secondary	Change in self-efficacy in well-being (SEWB) community domain score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving SEWB-community as measured by the Self-Efficacy in Well-Being Domains Scale community well-being domain score.	baseline, 30 days, and 60 days
Secondary	Change in self-efficacy in well-being (SEWB) occupational domain score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving SEWB-occupational as measured by the Self-Efficacy in Well-Being Domains Scale occupational well-being domain score.	baseline, 30 days, and 60 days
Secondary	Change in self-efficacy in well-being (SEWB) physical domain score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving SEWB- physical as measured by the Self-Efficacy in Well-Being Domains Scale physical well-being domain score.	baseline, 30 days, and 60 days
Secondary	Change in self-efficacy in well-being (SEWB) psychological domain score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving SEWB- psychological as measured by the Self-Efficacy in Well-Being Domains Scale psychological well-being domain score.	baseline, 30 days, and 60 days
Secondary	Change in self-efficacy in well-being (SEWB) economic domain score between baseline and time 3.	The investigators will assess the efficacy of FFW on improving SEWB- economic as measured by the Self-Efficacy in Well-Being Domains Scale economic well-being domain score.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW and change on overall well-being will be partially mediated by improvements in SEWB-overall over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW on interpersonal well-being will be partially mediated by improvements in SEWB-interpersonal over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW on community well-being will be partially mediated by improvements in SEWB-community over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW on occupational well-being will be partially mediated by improvements in SEWB- occupational over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW on physical well-being will be partially mediated by improvements in SEWB- physical over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW on economic well-being will be partially mediated by improvements in SEWB- economic over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW and change on HRQOL-PC will be partially mediated by improvements in SEWB-overall over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW and change on HRQOL-PC will be partially mediated by improvements in SEWB-interpersonal over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW and change on HRQOL-PC will be partially mediated by improvements in SEWB-community over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW and change on HRQOL-PC will be partially mediated by improvements in SEWB-occupational over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW and change on HRQOL-PC will be partially mediated by improvements in SEWB- physical over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW and change on HRQOL-PC will be partially mediated by improvements in SEWB- psychological over time.	baseline, 30 days, and 60 days
Secondary	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.	The investigators will assess if the effect of FFW and change on HRQOL-PC will be partially mediated by improvements in SEWB-economic over time.	baseline, 30 days, and 60 days