Well-Being and Physical Activity Study

NCT ID: NCT03194854

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2018-11-18

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).

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:

1. The FFW intervention will exert a positive direct effect on well-being self-efficacy.

2. The FFW intervention will exert a positive direct effect on subjective well-being.

3. 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:

1. The FFW intervention will exert a positive direct effect on well-being actions self-efficacy.

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

3. The FFW intervention will exert a positive direct effect on self-efficacy to regulate physical activity.

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fun For Wellness (FFW)

Intervention Type: 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.

Usual Care (UC)

The Usual Care (UC) group will conduct their lives as usual during the 30 day intervention period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan State University

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Isaac Prilleltensky

Professor, School of Education and Human Development; Vice Provost, Office of Institutional Culture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isaac Prilleltensky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor, University of Miami, School of Education and Human Development; Vice Provost, Office of Institutional Culture

Nicholas D. Myers, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Michigan State University, Department of Kinesiology

Locations

University of Miami

Coral Gables, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40853442 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40248477 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39206182 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39022641 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34794118 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34173135 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32130110 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31196052 (View on PubMed)

Other Identifiers

20170541

Identifier Type: -

Identifier Source: org_study_id