Physical Activity Clinical Trial
Official title:
Behavioral Economics Framingham Incentive Trial: A Randomized Controlled Trial
BE FIT (Behavioral Economics Framingham Incentive Trial) is a pilot study to test the deployment of a social incentive intervention using the Framingham Heart Study (FHS) Offspring, Generation 3, and Omni cohorts to increase physical activity (PA). The investigators will leverage the strength of FHS by recruiting trios and nuclear families to test whether social connectedness increases PA. The investigators will utilize a randomized controlled trial design. The investigators will test a social incentive intervention strategy using a team-based design in which participants work together to jointly achieve their PA goals, and a social connectedness intervention.
Physical inactivity is associated with cardiovascular disease (CVD) risk factors, including
obesity, diabetes, dyslipidemia, and hypertension, and an increased risk for CVD and death.
In the Framingham Heart Study (FHS) Third Generation (Gen 3) and multiethnic Omni 2 cohort
participants, objectively measured accelerometry physical activity (PA) data showed that
moderate to vigorous PA was associated with healthier CVD risk factor profiles.6 Despite the
health benefits of engaging in PA, only about half of FHS participants are achieving U.S.
recommended aerobic PA guidelines, consistent with the low rates observed in adults
nationally. Experts estimate that increasing PA by only 10% would annually save ½ million
lives worldwide.
There has been a lot of interest in using "social" or team-based designs to increase PA.
Prior evaluations of the FHS found that rates of smoking and obesity were associated with
social connectedness within social networks. Evidence from other industries has found that
interventions using social comparisons feedback to change electricity use were effective,
but only if paired with appropriate social approval or disapproval. PA interventions could
leverage such social incentives to design interventions that increase peer support,
accountability, and unity towards a common goal. In five pilot studies conducted in 2014 at
the University of Pennsylvania, the investigators have found that different incentive and
feedback designs resulted in differential effectiveness. These preliminary data support the
notion that careful testing of alternative social incentive combinations are important to
conduct before deciding which intervention to scale more broadly.
The rapidly expanding availability of mobile technologies provides a resource effective way
to implement social incentive interventions to improve health. Many types of health devices
(e.g. glucometers, pedometers) provide individual feedback on performance (e.g. blood sugar
or step count). With wireless devices it is technologically feasible to provide relative
feedback at periodic intervals. However, utilizing mobile health (mHealth) devices is rarely
done and could represent a significant opportunity to improve health behavior at low cost.
For our study, the investigators will leverage the University of Pennsylvania's NIH-funded
Way to Health infrastructure. The platform incorporates automated inputs from wireless
devices to capture behavior and deliver automated feedback to participants. While conducting
the 5 pilot studies noted above, the investigators found that most smartphones and wearable
devices were accurate for tracking physical activity data.
The investigators are conducting a pilot study and leveraging information acquired through
our Digital Connectedness Survey to test the deployment of a social incentive intervention
using the FHS Offspring, Generation 3, and Omni cohorts to increase PA. The investigators
will leverage the strength of FHS by recruiting trios and nuclear families to test whether
social connectedness increases PA. The investigators will utilize a randomized controlled
trial design. The investigators will test a social incentive intervention strategy using a
team-based design in which participants work together to jointly achieve their PA goals, and
a social connectedness intervention. The primary outcome of the intervention pilot study
will be the proportion of individual participant-days that the goal is achieved over a
12-week intervention period. Individuals find PA maintenance challenging and PA
sustainability has not been studied systematically. As a secondary aim of the intervention
study, the investigators will examine PA goal achievement durability for 12 weeks after the
intervention ends.
Specific Aims:
Aim 1. To test the feasibility of using a team-based social incentive intervention to
increase PA in FHS participants. H1: The demographic and clinical characteristics of
individuals who agrees to be randomized are younger and healthier than those who do not
agree to participate. H2: FHS participants who elect the Fitbit in place of the Moves app
will differ based on demographic and clinical characteristics.
Aim 2. To evaluate the effectiveness of a team-based social incentive intervention to
achieve PA goals among connected individuals on a team compared to a control group of
individuals. H4: A team-based social incentive intervention comprised of connected
individuals on a team is more effective for achieving PA goals than a control group of
individuals.
Secondary Aim. To evaluate whether differences in achieving PA goals between study arms
during the 12-week intervention are sustained during the 12-week follow-up period. H6: PA
levels in the 12-week follow-up will decline for all arms but remain different in a similar
fashion to that during the intervention period.
This study has the potential to address the major public health problem of sedentary
lifestyle, with its consequent increased risks of obesity and CVD risk factor progression.
The investigators bring together a multi-disciplinary team with expertise in PA, CVD
epidemiology, biostatistics, and behavioral economics. The investigators propose an
innovative linking of a classical randomized clinical trial (RCT) design with the many
strengths of the epidemiological FHS. This pilot RCT will examine the effectiveness of
different approaches to leveraging social incentives to improve health behaviors, an area
with considerable promise for increasing the effectiveness of a variety of health
interventions. Ultimately the goal is to leverage this pilot study to implement a larger
study in the FHS. The investigators also anticipate ultimately linking these results with
the extant FHS genetics databases.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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