Well-Being and Physical Activity Study

April 13, 2022 updated by: Isaac Prilleltensky, University of Miami
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 30 days, and 60 days
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.
baseline, 30 days, and 60 days
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
baseline, 30 days, and 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
The FFW intervention will exert a positive direct effect on job-related physical activity self-efficacy.
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
The FFW intervention will exert a positive direct effect on transportation-related physical activity self-efficacy.
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
The FFW intervention will exert a positive direct effect on domestic-related physical activity self-efficacy.
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
The FFW intervention will exert a positive direct effect on leisure-related physical activity self-efficacy.
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
The FFW intervention will exert a positive direct effect on self-efficacy to regulate physical activity.
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
The FFW intervention will exert a positive direct effect on physical activity.
baseline, 30 days, and 60 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 30 days, and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Michigan State University

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 8, 2018

Primary Completion (ACTUAL)

November 18, 2018

Study Completion (ACTUAL)

November 18, 2018

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (ACTUAL)

June 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20170541

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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