Well-Being and Physical Activity Study

Health Promotion Clinical Trial

Official title:

Well-Being and Physical Activity Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194854
• Other study ID #: 20170541
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: November 18, 2018

Study information

• Verified date: April 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: November 18, 2018
• Est. primary completion date: November 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Promotion

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationships between FFW intervention and SF36v2 scores.	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
Primary	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
Primary	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
Primary	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	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.	baseline, 30 days, and 60 days
Secondary	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.	baseline, 30 days, and 60 days
Secondary	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.	baseline, 30 days, and 60 days
Secondary	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.	baseline, 30 days, and 60 days
Secondary	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.	baseline, 30 days, and 60 days
Secondary	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.	baseline, 30 days, and 60 days
Secondary	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.	baseline, 30 days, and 60 days