Health PromotionNCT03060213
Fun For Wellness: Online Well-Being Promotion Intervention in a Patient Sample
A study testing Fun For Wellness (FFW) in people with Health Promotion, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Fun For Wellness (FFW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 15 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: A Randomized Controlled Trial in a Community-Based Patient Sample
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.
Read the 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
- Being tested
- Fun For Wellness (FFW)
- 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
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fun For Wellness (FFW)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fun For Wellness (FFW) | Experimental | 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. Receives: Behavioral: Fun For Wellness (FFW) |
| Usual Care (UC) | No intervention | The Usual Care (UC) group will conduct their lives as usual during the 30 day intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (time 1), 30 days (time 2), and 60 days (time 3)
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
Measured: baseline (time 1), 30 days (time 2), and 60 days (time 3)
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.
Measured: baseline (time 1), 30 days (time 2), and 60 days (time 3)
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.
Measured: baseline (time 1), 30 days (time 2), and 60 days (time 3)
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.
Measured: baseline (time 1), 30 days (time 2), and 60 days (time 3)
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.
Measured: baseline (time 1), 30 days (time 2), and 60 days (time 3)
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.
Measured: baseline (time 1), 30 days (time 2), and 60 days (time 3)
Secondary outcomes (21)
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.
Measured: baseline, 30 days, and 60 days
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.
Measured: baseline, 30 days, and 60 days
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.
Measured: baseline, 30 days, and 60 days
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.
Measured: baseline, 30 days, and 60 days
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.
Measured: baseline, 30 days, and 60 days
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.
Measured: baseline, 30 days, and 60 days
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.
Measured: baseline, 30 days, and 60 days
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.
Measured: 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.
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.
Measured: 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.
The investigators will assess if the effect of FFW on interpersonal well-being will be partially mediated by improvements in SEWB-interpersonal over time.
Measured: 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.
The investigators will assess if the effect of FFW on community well-being will be partially mediated by improvements in SEWB-community over time.
Measured: 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.
The investigators will assess if the effect of FFW on occupational well-being will be partially mediated by improvements in SEWB- occupational over time.
Measured: 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.
The investigators will assess if the effect of FFW on physical well-being will be partially mediated by improvements in SEWB- physical over time.
Measured: 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.
The investigators will assess if the effect of FFW on economic well-being will be partially mediated by improvements in SEWB- economic over time.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: baseline, 30 days, and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start6 Mar 2017
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isaac Prilleltensky, University of Miami
- Investigators
- Isaac Prilleltensky, Ph.D., Principal investigator, Dean, School of Education and Human Development; Professor; Vice Provost, Office of Institutional Culture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060213
- Sponsor's protocol ID
- 20170001
- Status last verified
- Apr 2022
- First submitted
- 13 Feb 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: A Randomized Controlled Trial in a Community-Based Patient Sample
- ClinicalTrials.gov ID
- NCT03060213
- Acronym / sponsor ID
- 20170001
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fun For Wellness (FFW) | Experimental | Behavioral: 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. |
| Usual Care (UC) | No intervention | –The Usual Care (UC) group will conduct their lives as usual during the 30 day intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Fun For Wellness (FFW) |
Primary outcome
Change in overall well-being I COPPE Scale scores between baseline and time 3.
Time frame: 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 interpersonal well-being I COPPE Scale score between baseline and time 3.
Time frame: 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 community well-being I COPPE Scale score between baseline and time 3.
Time frame: 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.
Time frame: 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 physical well-being I COPPE Scale score between baseline and time 3.
Time frame: 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.
Change in psychological well-being I COPPE Scale score between baseline and time 3.
Time frame: 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 economic well-being I COPPE Scale score between baseline and time 3.
Time frame: 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.
21 secondary outcomes
Change in health-related quality of life (HRQOL)-physical component score between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in self-efficacy in well-being (SEWB) overall domain score between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in self-efficacy in well-being (SEWB) interpersonal domain score between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in self-efficacy in well-being (SEWB) community domain score between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in self-efficacy in well-being (SEWB) occupational domain score between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in self-efficacy in well-being (SEWB) physical domain score between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in self-efficacy in well-being (SEWB) psychological domain score between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in self-efficacy in well-being (SEWB) economic domain score between baseline and time 3.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 30 days, and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Prilleltensky, Ph.D. principal investigator
Dean, School of Education and Human Development; Professor; Vice Provost, Office of Institutional Culture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fun For Wellness (FFW) in people with Health Promotion, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall well-being I COPPE Scale scores between baseline and time 3. (time frame: baseline (time 1), 30 days (time 2), and 60 days (time 3)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.