NCT03194854

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2018

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

June 19, 2017

Last Update Submit

April 13, 2022

Conditions

Health Promotion

Keywords

e-Healthself-efficacy theorymixture modelingmobile healthcomplier average causal effect estimation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    baseline, 30 days, and 60 days

Secondary Outcomes (7)

  • Change in Well-Being Actions Self-Efficacy (WBASE) Scale scores between baseline and time 3.

    baseline, 30 days, and 60 days

  • Change in Job-Related Physical Activity Self-Efficacy (J-R PASE) Scale scores between baseline and time 3.

    baseline, 30 days, and 60 days

  • Change in Transportation-Related Physical Activity Self-Efficacy (T-R PASE) Scale scores between baseline and time 3.

    baseline, 30 days, and 60 days

  • Change in Domestic-Related Physical Activity Self-Efficacy (D-R PASE) Scale scores between baseline and time 3.

    baseline, 30 days, and 60 days

  • Change in Leisure-Related Physical Activity Self-Efficacy (L-R PASE) Scale scores between baseline and time 3.

    baseline, 30 days, and 60 days

  • +2 more secondary outcomes

Other Outcomes (1)

  • Relationships between FFW intervention and SF36v2 scores.

    baseline, 30 days, and 60 days

Study Arms (2)

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.

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.

Interventions

Fun For Wellness (FFW)BEHAVIORAL

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

Fun For Wellness (FFW)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (8)

  • 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. 2025 Aug 25. doi: 10.1007/s10865-025-00586-7. Online ahead of print.

    PMID: 40853442DERIVED

  • Myers 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.

    PMID: 40248477DERIVED

  • Myers 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.

    PMID: 39206182DERIVED

  • Lee 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.

    PMID: 39022641DERIVED

  • Myers 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.

    PMID: 34794118DERIVED

  • Myers 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.

    PMID: 34173135DERIVED

  • Myers 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.

    PMID: 32130110DERIVED

  • Myers 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.

    PMID: 31196052DERIVED

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Education and Human Development; Vice Provost, Office of Institutional Culture

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 21, 2017

Study Start

August 8, 2018

Primary Completion

November 18, 2018

Study Completion

November 18, 2018

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)