Well-Being and Physical Activity Study



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 64
Updated:1/11/2019
Start Date:August 8, 2018
End Date:November 18, 2018

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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).

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.

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
We found this trial at
1
site
Coral Gables, Florida 33146
?
mi
from
Coral Gables, FL
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