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Well-Being and Physical Activity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194854
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Michigan State University
Information provided by (Responsible Party):
Isaac Prilleltensky, University of Miami

Brief 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 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).

Condition or disease Intervention/treatment Phase
Health Promotion Behavioral: Fun For Wellness (FFW) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: Participants who have completed the full online T1 battery will be randomly assigned in real-time by the computer to either the intervention condition or the UC control condition. Randomization, group assignment, and assessments will be conducted solely by the computer program, so researchers will be blind to participant randomization, group assignment, and participant group identity during assessment times. With regard to group size and power, experience from our prior efficacy study of FFW indicates that for the current study, the computer program will use a 1:1 randomization algorithm.
Primary Purpose: Treatment
Official Title: Well-Being and Physical Activity Study
Actual Study Start Date : August 8, 2018
Actual Primary Completion Date : November 18, 2018
Actual Study Completion Date : November 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Usual Care (UC)
The Usual Care (UC) group will conduct their lives as usual during the 30 day intervention period.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. Change in Well-Being Actions Self-Efficacy (WBASE) 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 self-efficacy.

  2. 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 ]
    The FFW intervention will exert a positive direct effect on job-related physical activity self-efficacy.

  3. 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 ]
    The FFW intervention will exert a positive direct effect on transportation-related physical activity self-efficacy.

  4. 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 ]
    The FFW intervention will exert a positive direct effect on domestic-related physical activity self-efficacy.

  5. 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 ]
    The FFW intervention will exert a positive direct effect on leisure-related physical activity self-efficacy.

  6. Change in Self-Efficacy to Regulate Physical Activity (SERPA) 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 self-efficacy to regulate physical activity.

  7. Change in Long International Physical Activity Questionnaire (Long-IPAQ) scores between baseline and time 3 [ Time Frame: baseline, 30 days, and 60 days ]
    The FFW intervention will exert a positive direct effect on physical activity.


Other Outcome Measures:
  1. Relationships between FFW intervention and SF36v2 scores. [ Time Frame: baseline, 30 days, and 60 days ]
    Exploratory analyses will be conducted to examine possible relationships between the FFW intervention and health-related quality of life.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

There are seven eligibility criteria for participation in this study.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194854


Locations
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United States, Florida
University of Miami
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
University of Miami
Michigan State University
Investigators
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Principal Investigator: Isaac Prilleltensky, Ph.D. Professor, University of Miami, School of Education and Human Development; Vice Provost, Office of Institutional Culture
Principal Investigator: Nicholas D. Myers, Ph.D. Associate Professor, Michigan State University, Department of Kinesiology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Isaac Prilleltensky, Professor, School of Education and Human Development; Vice Provost, Office of Institutional Culture, University of Miami
ClinicalTrials.gov Identifier: NCT03194854    
Other Study ID Numbers: 20170541
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isaac Prilleltensky, University of Miami:
e-Health
self-efficacy theory
mixture modeling
mobile health
complier average causal effect estimation