Health PromotionNCT03194854
Well-Being and Physical Activity Study
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
Fun For Wellness (FFW) is an online behavioral intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities to participants. This study is a randomized controlled trial (RCT) designed to provide an initial evaluation of the effectiveness of FFW to increase well-being… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy 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
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 18 Nov 2018
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- individual is at least 18 years old but not older than 64 years old
- individual has access to a technological device (e.g., computer) that can access the online intervention
- individual lives in the United States of America
- individual is not simultaneously enrolled in another program promoting either well-being or physical activity
- individual has a body mass index (BMI) ≥ 25.00 kg/m2
Who cannot join
- individual is less than 18 years old or older than 64 years old
- individual does not have access to a technological device (e.g., computer) that can access the online intervention
- individual does not live in the United States of America
- individual is simultaneously enrolled in another program promoting either well-being or physical activity
- individual has a body mass index (BMI) < 25.00
Trial locations and contacts
1 site in 1 country.
About this study
Fun For Wellness (FFW) is an online behavioral intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities to participants. This study is a randomized controlled trial (RCT) designed to provide an initial evaluation of the effectiveness of FFW to increase well-being and physical activity in an obese adult population in the United States of America. The conceptual framework for the FFW intervention is guided by self-efficacy theory. The FFW intervention consists of participants engaging in BET I CAN challenges. BET I CAN is an acronym that stands for behaviors, emotions, thoughts, interactions, awareness, and next steps. The FFW intervention is conceptualized as exerting both a positive direct effect, and a positive indirect effect through self-efficacy (i.e., well-being self-efficacy), on well-being (i.e., subjective well-being and well-being actions).
Read the detailed description
The World Health Organization (WHO) estimates that 650 million adults are obese and that this number has tripled since 1975. To reduce adult obesity the WHO recommends that individuals limit energy intake from low quality food sources (e.g., highly processed foods high in fat), increase energy intake from high quality food sources (e.g., raw vegetables), and engage in regular physical activity (e.g., 150 minutes at moderate intensity per week). There is evidence, that well-designed cognitive-behavioral interventions can successfully promote physical activity in obese adults.
Insufficient physical activity in the general adult population is a global pandemic. At the individual-level, there is evidence that behavioral interventions designed to promote physical activity by focusing on personal psychological attributes (e.g., self-efficacy) can be effective. Delivering a physical activity intervention online has been shown to be an effective mode of delivery that also may allow for efficient scaling up of an intervention. Thus, a readily scalable online behavioral intervention that effectively promotes physical activity in obese adults may be useful in regard to responding to a global pandemic (i.e., physical inactivity) in an at-risk population (i.e., obese adults).
The conceptual framework for the Fun For Wellness intervention is based on self-efficacy theory. Over the past few decades, self-efficacy theory has been one of the most widely studied conceptual frameworks in sport and exercise psychology. FFW is an online behavioral intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities to participants. For participants who comply with the intervention, some initial evidence has been provided for the efficacy of FFW to promote: well-being self-efficacy; interpersonal, community, psychological and economic subjective well-being; and, interpersonal and physical well-being actions.
A panel company will invite participants from their General Population member panel to go to the research webpage to be screened for the study. No more than six hundred obese adults (BMI ≥ 25.00 kg/m2) between 18 and 64 years old will be randomly assigned to the FFW or Usual Care (UC) group to achieve a 1:1 group (i.e. FFW:UC) assignment. Recruitment, eligibility verification and data collection will be conducted online. Data will be collected at baseline, 30 days and 60 days post-baseline. Instruments to measure demographic information, anthropometric characteristics, self-efficacy, physical activity, well-being, and health-related quality of life will be included in the battery. Data will be modeled under both an intent to treat approach and a complier average causal effect approach.
Primary outcomes are: well-being self-efficacy, subjective well-being and well-being actions.
Hypotheses for intervention compliers are:
- The FFW intervention will exert a positive direct effect on well-being self-efficacy.
- The FFW intervention will exert a positive direct effect on subjective well-being.
- The FFW intervention will exert a positive direct effect on well-being actions.
Secondary outcomes are: well-being actions self-efficacy, physical activity self-efficacy, self-efficacy to regulate physical activity, and physical activity.
Hypotheses for intervention compliers are:
- The FFW intervention will exert a positive direct effect on well-being actions self-efficacy.
- The FFW intervention will exert a positive direct effect on physical activity self-efficacy.
- The FFW intervention will exert a positive direct effect on self-efficacy to regulate physical activity.
- The FFW intervention will exert a positive direct effect on physical activity.
Exploratory analyses will be conducted to examine possible relationships between the FFW intervention and health-related quality of life.
- Conditions
- Health Promotion
- Being tested
- Fun For Wellness (FFW)
- Keywords
- e-Health, self-efficacy theory, mixture modeling, mobile health, complier average causal effect estimation
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 Self-Efficacy (WBSE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on well-being self-efficacy.
Measured: baseline, 30 days, and 60 days
Change in subjective well-being I COPPE Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on subjective well-being.
Measured: baseline, 30 days, and 60 days
Change in I COPPE Actions Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on well-being actions
Measured: baseline, 30 days, and 60 days
Secondary outcomes (7)
Change in Well-Being Actions Self-Efficacy (WBASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on well-being actions self-efficacy.
Measured: baseline, 30 days, and 60 days
Change in Job-Related Physical Activity Self-Efficacy (J-R PASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on job-related physical activity self-efficacy.
Measured: baseline, 30 days, and 60 days
Change in Transportation-Related Physical Activity Self-Efficacy (T-R PASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on transportation-related physical activity self-efficacy.
Measured: baseline, 30 days, and 60 days
Change in Domestic-Related Physical Activity Self-Efficacy (D-R PASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on domestic-related physical activity self-efficacy.
Measured: baseline, 30 days, and 60 days
Change in Leisure-Related Physical Activity Self-Efficacy (L-R PASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on leisure-related physical activity self-efficacy.
Measured: baseline, 30 days, and 60 days
Change in Self-Efficacy to Regulate Physical Activity (SERPA) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on self-efficacy to regulate physical activity.
Measured: baseline, 30 days, and 60 days
Change in Long International Physical Activity Questionnaire (Long-IPAQ) scores between baseline and time 3
The FFW intervention will exert a positive direct effect on physical activity.
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 posted21 Jun 2017
- Study start8 Aug 2018
- Primary completion18 Nov 2018
- Study completion18 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- 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 self-efficacy, physical activity, and well-being. 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
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Principal investigator, Isaac Prilleltensky, University of Miami
- Investigators
- Isaac Prilleltensky, Ph.D., Principal investigator, Professor, University of Miami, School of Education and Human Development; Vice Provost, Office of Institutional CultureNicholas D. Myers, Ph.D., Principal investigator, Associate Professor, Michigan State University, Department of Kinesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194854
- Sponsor's protocol ID
- 20170541
- Status last verified
- Apr 2022
- First submitted
- 19 Jun 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
Publications
Myers ND, Prilleltensky I, Lee S. Measuring stability and change in response patterns to a set of hierarchical scales in a randomized intervention study: an innovative application of latent transition analysis. J Behav Med. 2026 Apr;49(2):157-175. doi: 10.1007/s10865-025-00586-7. Epub 2025 Aug 25.
PubMed 40853442Myers ND, Brincks AM, Lee S. Direct and Indirect Causal Effects of an Individual Randomized Physical Activity-Promoting Intervention: A Substantive-Methodological Synergy. Meas Phys Educ Exerc Sci. 2025;29(1):24-42. doi: 10.1080/1091367x.2024.2392563. Epub 2024 Aug 19.
PubMed 40248477Myers ND, Brincks AM, Lee S. Using Directed Acyclic Graphs (DAGs) to Determine if the Total Causal Effect of an Individual Randomized Physical Activity-Promoting Intervention is Identifiable. Meas Phys Educ Exerc Sci. 2024;28(3):267-282. doi: 10.1080/1091367x.2024.2318355. Epub 2024 Feb 19.
PubMed 39206182Lee S, Myers ND, Bateman AG, Prilleltensky I, McMahon A, Brincks AM. Baseline self-efficacy predicts subsequent engagement behavior in an online physical activity intervention. Front Sports Act Living. 2024 Jul 3;6:1401206. doi: 10.3389/fspor.2024.1401206. eCollection 2024.
PubMed 39022641Myers ND, Bateman AG, McMahon A, Prilleltensky I, Lee S, Prilleltensky O, Pfeiffer KA, Brincks AM. Measurement of Physical Activity Self-Efficacy in Adults With Obesity: A Latent Variable Approach to Explore Dimensionality, Temporal Invariance, and External Validity. J Sport Exerc Psychol. 2021 Nov 18;43(6):497-513. doi: 10.1123/jsep.2021-0040.
PubMed 34794118Myers ND, Prilleltensky I, McMahon A, Brincks AM, Lee S, Prilleltensky O, Pfeiffer KA, Bateman AG. Mechanisms by Which the Fun for Wellness Intervention May Promote Subjective Well-Being in Adults with Obesity: a Reanalysis Using Baseline Target Moderation. Prev Sci. 2023 Feb;24(2):286-298. doi: 10.1007/s11121-021-01274-z. Epub 2021 Jun 25.
PubMed 34173135Myers ND, McMahon A, Prilleltensky I, Lee S, Dietz S, Prilleltensky O, Pfeiffer KA, Bateman AG, Brincks AM. Effectiveness of the Fun for Wellness Web-Based Behavioral Intervention to Promote Physical Activity in Adults With Obesity (or Overweight): Randomized Controlled Trial. JMIR Form Res. 2020 Feb 21;4(2):e15919. doi: 10.2196/15919.
PubMed 32130110Myers ND, Prilleltensky I, Lee S, Dietz S, Prilleltensky O, McMahon A, Pfeiffer KA, Ellithorpe ME, Brincks AM. Effectiveness of the fun for wellness online behavioral intervention to promote well-being and physical activity: protocol for a randomized controlled trial. BMC Public Health. 2019 Jun 13;19(1):737. doi: 10.1186/s12889-019-7089-2.
PubMed 31196052
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
- Well-Being and Physical Activity Study
- ClinicalTrials.gov ID
- NCT03194854
- Acronym / sponsor ID
- 20170541
- Conditions
- Health Promotion
- Keywords
- e-Health, self-efficacy theory, mixture modeling, mobile health, complier average causal effect estimation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 18 Nov 2018 (actual)
- Study completion
- 18 Nov 2018 (actual)
- First posted
- 21 Jun 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.
Fun For Wellness (FFW) is an online behavioral intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities to participants. This study is a randomized controlled trial (RCT) designed to provide an initial evaluation of the effectiveness of FFW to increase well-being and physical activity in an obese adult population in the United States of America. The conceptual framework for the FFW intervention is guided by self-efficacy theory. The FFW intervention consists of participants engaging in BET I CAN challenges. BET I CAN is an acronym that stands for behaviors, emotions, thoughts, interactions, awareness, and next steps. The FFW intervention is conceptualized as exerting both a positive direct effect, and a positive indirect effect through self-efficacy (i.e., well-being self-efficacy), on well-being (i.e., subjective well-being and well-being actions).
Detailed description
The World Health Organization (WHO) estimates that 650 million adults are obese and that this number has tripled since 1975. To reduce adult obesity the WHO recommends that individuals limit energy intake from low quality food sources (e.g., highly processed foods high in fat), increase energy intake from high quality food sources (e.g., raw vegetables), and engage in regular physical activity (e.g., 150 minutes at moderate intensity per week). There is evidence, that well-designed cognitive-behavioral interventions can successfully promote physical activity in obese adults.
Insufficient physical activity in the general adult population is a global pandemic. At the individual-level, there is evidence that behavioral interventions designed to promote physical activity by focusing on personal psychological attributes (e.g., self-efficacy) can be effective. Delivering a physical activity intervention online has been shown to be an effective mode of delivery that also may allow for efficient scaling up of an intervention. Thus, a readily scalable online behavioral intervention that effectively promotes physical activity in obese adults may be useful in regard to responding to a global pandemic (i.e., physical inactivity) in an at-risk population (i.e., obese adults).
The conceptual framework for the Fun For Wellness intervention is based on self-efficacy theory. Over the past few decades, self-efficacy theory has been one of the most widely studied conceptual frameworks in sport and exercise psychology. FFW is an online behavioral intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities to participants. For participants who comply with the intervention, some initial evidence has been provided for the efficacy of FFW to promote: well-being self-efficacy; interpersonal, community, psychological and economic subjective well-being; and, interpersonal and physical well-being actions.
A panel company will invite participants from their General Population member panel to go to the research webpage to be screened for the study. No more than six hundred obese adults (BMI ≥ 25.00 kg/m2) between 18 and 64 years old will be randomly assigned to the FFW or Usual Care (UC) group to achieve a 1:1 group (i.e. FFW:UC) assignment. Recruitment, eligibility verification and data collection will be conducted online. Data will be collected at baseline, 30 days and 60 days post-baseline. Instruments to measure demographic information, anthropometric characteristics, self-efficacy, physical activity, well-being, and health-related quality of life will be included in the battery. Data will be modeled under both an intent to treat approach and a complier average causal effect approach.
Primary outcomes are: well-being self-efficacy, subjective well-being and well-being actions.
Hypotheses for intervention compliers are:
- The FFW intervention will exert a positive direct effect on well-being self-efficacy.
- The FFW intervention will exert a positive direct effect on subjective well-being.
- The FFW intervention will exert a positive direct effect on well-being actions.
Secondary outcomes are: well-being actions self-efficacy, physical activity self-efficacy, self-efficacy to regulate physical activity, and physical activity.
Hypotheses for intervention compliers are:
- The FFW intervention will exert a positive direct effect on well-being actions self-efficacy.
- The FFW intervention will exert a positive direct effect on physical activity self-efficacy.
- The FFW intervention will exert a positive direct effect on self-efficacy to regulate physical activity.
- The FFW intervention will exert a positive direct effect on physical activity.
Exploratory analyses will be conducted to examine possible relationships between the FFW intervention and health-related quality of life.
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 self-efficacy, physical activity, and well-being. 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 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- individual is at least 18 years old but not older than 64 years old
- individual has access to a technological device (e.g., computer) that can access the online intervention
- individual lives in the United States of America
- individual is not simultaneously enrolled in another program promoting either well-being or physical activity
- individual has a body mass index (BMI) ≥ 25.00 kg/m2
Key exclusion criteria (5 listed)
- individual is less than 18 years old or older than 64 years old
- individual does not have access to a technological device (e.g., computer) that can access the online intervention
- individual does not live in the United States of America
- individual is simultaneously enrolled in another program promoting either well-being or physical activity
- individual has a body mass index (BMI) < 25.00
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 Self-Efficacy (WBSE) Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
The FFW intervention will exert a positive direct effect on well-being self-efficacy.
Change in subjective well-being I COPPE Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
The FFW intervention will exert a positive direct effect on subjective well-being.
Change in I COPPE Actions Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
The FFW intervention will exert a positive direct effect on well-being actions
7 secondary outcomes
Change in Well-Being Actions Self-Efficacy (WBASE) Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in Job-Related Physical Activity Self-Efficacy (J-R PASE) Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in Transportation-Related Physical Activity Self-Efficacy (T-R PASE) Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in Domestic-Related Physical Activity Self-Efficacy (D-R PASE) Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in Leisure-Related Physical Activity Self-Efficacy (L-R PASE) Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in Self-Efficacy to Regulate Physical Activity (SERPA) Scale scores between baseline and time 3.
Time frame: baseline, 30 days, and 60 days
Change in Long International Physical Activity Questionnaire (Long-IPAQ) 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.
- Derived from this study: PubMed 40853442Myers ND, Prilleltensky I, Lee S. Measuring stability and change in response patterns to a set of hierarchical scales in a randomized intervention study: an innovative application of latent transition analysis. J Behav Med. 2026 Apr;49(2):157-175. doi: 10.1007/s10865-025-00586-7. Epub 2025 Aug 25.
- Derived from this study: PubMed 40248477Myers ND, Brincks AM, Lee S. Direct and Indirect Causal Effects of an Individual Randomized Physical Activity-Promoting Intervention: A Substantive-Methodological Synergy. Meas Phys Educ Exerc Sci. 2025;29(1):24-42. doi: 10.1080/1091367x.2024.2392563. Epub 2024 Aug 19.
- Derived from this study: PubMed 39206182Myers ND, Brincks AM, Lee S. Using Directed Acyclic Graphs (DAGs) to Determine if the Total Causal Effect of an Individual Randomized Physical Activity-Promoting Intervention is Identifiable. Meas Phys Educ Exerc Sci. 2024;28(3):267-282. doi: 10.1080/1091367x.2024.2318355. Epub 2024 Feb 19.
- Derived from this study: PubMed 39022641Lee S, Myers ND, Bateman AG, Prilleltensky I, McMahon A, Brincks AM. Baseline self-efficacy predicts subsequent engagement behavior in an online physical activity intervention. Front Sports Act Living. 2024 Jul 3;6:1401206. doi: 10.3389/fspor.2024.1401206. eCollection 2024.
- Derived from this study: PubMed 34794118Myers ND, Bateman AG, McMahon A, Prilleltensky I, Lee S, Prilleltensky O, Pfeiffer KA, Brincks AM. Measurement of Physical Activity Self-Efficacy in Adults With Obesity: A Latent Variable Approach to Explore Dimensionality, Temporal Invariance, and External Validity. J Sport Exerc Psychol. 2021 Nov 18;43(6):497-513. doi: 10.1123/jsep.2021-0040.
- Derived from this study: PubMed 34173135Myers ND, Prilleltensky I, McMahon A, Brincks AM, Lee S, Prilleltensky O, Pfeiffer KA, Bateman AG. Mechanisms by Which the Fun for Wellness Intervention May Promote Subjective Well-Being in Adults with Obesity: a Reanalysis Using Baseline Target Moderation. Prev Sci. 2023 Feb;24(2):286-298. doi: 10.1007/s11121-021-01274-z. Epub 2021 Jun 25.
- Derived from this study: PubMed 32130110Myers ND, McMahon A, Prilleltensky I, Lee S, Dietz S, Prilleltensky O, Pfeiffer KA, Bateman AG, Brincks AM. Effectiveness of the Fun for Wellness Web-Based Behavioral Intervention to Promote Physical Activity in Adults With Obesity (or Overweight): Randomized Controlled Trial. JMIR Form Res. 2020 Feb 21;4(2):e15919. doi: 10.2196/15919.
- Derived from this study: PubMed 31196052Myers ND, Prilleltensky I, Lee S, Dietz S, Prilleltensky O, McMahon A, Pfeiffer KA, Ellithorpe ME, Brincks AM. Effectiveness of the fun for wellness online behavioral intervention to promote well-being and physical activity: protocol for a randomized controlled trial. BMC Public Health. 2019 Jun 13;19(1):737. doi: 10.1186/s12889-019-7089-2.
- 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
Professor, University of Miami, School of Education and Human Development; Vice Provost, Office of Institutional Culture
Nicholas D. Myers, Ph.D. principal investigator
Associate Professor, Michigan State University, Department of Kinesiology
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 5 inclusion and 5 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 Self-Efficacy (WBSE) Scale scores between baseline and time 3. (time frame: baseline, 30 days, and 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194854, which also lists 8 linked publications.
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.