Clinical trial NCT03253406: Health Wearables and College Student Health
Official title: Use of Health Wearables to Improve Physical Activity and Eating Behaviors Among College Students: A 12-week Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Change
Physical Activity
Young Adults
Technology
Intervention
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm randomized pilot trial design will be used, with one Experimental Group and one Comparison Group. A random numbers table will be used to randomize participants with a 1:1 allocation ratio.
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot randomized trial is to determine (1) the effectiveness of the Polar M400, used in combination with a twice-weekly Facebook-delivered Social Cognitive Theory-based health intervention, in the promotion of more healthful physical activity and nutritious eating behaviors over 12 weeks in college students versus a comparison group; and (2) the validity and reliability of the Polar M400 in the assessment of free-living (i.e., non-laboratory based) physical activity (in this case, steps per day and daily durations of moderate and vigorous physical activity) and energy expenditure.

Detailed description: The prevalence of overweight and obesity among individuals 20-39 years of age is 60.9%. Unfortunately, physical inactivity and poor dietary practices among this age cohort appear to be two major contributory factors for the preceding statistic. Among the youngest individuals within this age cohort are college students. Research suggests college students possess risk factors for overweight and obesity as many of these individuals are now independent and, for some, making physical activity- and nutrition-related decisions autonomously for the first time. Studies on obesity- and weight-related behaviors in this population suggest approximately 25% to 30% of college students are overweight or obese. Desai et al. also suggested rates of complete physical inactivity among college students is between 37% and 46%. Unfortunately, dietary practices among college students are not ideal either.

Poor nutritional behaviors also contribute to risk factors among this population. In a study among college freshman and sophomores, Racette, Deusinger, Strube, Highstein, and Deusinger found that 70% of the 764 college students assessed consumed less than the U.S. Department of Agriculture (USDA) recommendations of two servings of fruit and three servings of vegetables daily. Strikingly, approximately half of the students surveyed also reported high-fat fast or fried food consumption ≥ 3 times in the past week. Notably, a subsample of these students was assessed again a year later with 70% of these students gaining, on average, four kilograms. Indeed, other studies have demonstrated the impact poor dietary practices (e.g., consumption of "junk foods", sugar-sweetened beverages, or fast foods high in fat and low in nutrient density) and obesogenic environments (e.g., continuously eating at buffet-style student dining halls) can have on weight gain from freshman year of college onward. As such, not only is it clear that theoretically-backed physical activity interventions are needed among college students, there is also a distinct need to include a dietary component within these interventions. Technology integration within these physical activity and nutritional interventions among college students might present a viable approach.

While few empirical data is available regarding health wearable use among young adults, it is likely that this technology-savvy age cohort represents a large proportion of the one in six consumers currently owning a health wearable. Further, with the number of health wearables sold in 2018 projected to be 110 million, it is likely that this age cohort will contribute substantially to this figure. Moreover, research indicates the popularity of social media among young adults. Indeed, among individuals 18-29 years of age, approximately 90% use at least one social media site. Currently, Facebook represents the most widely used social media site with 1.71 billion active users and individuals 18 to 34 years of age representing the majority of Facebook users.

Therefore, the combined use of health wearable technology, these devices' associated smartphone applications, and a theoretically-driven health intervention delivered via social media, may prove appealing and effective as a health promotion strategy among college students. Specifically, use of the Polar M400 may increase college students' ability to self-regulate physical activity behaviors as self-regulation is posited as an important factor in promoting behavior change. Further, the Polar M400's associated smartphone application-based and Internet-based portal allows individuals to not only track physical activity-related metrics, but view predicted energy expenditure as well, which may allow individuals to self-regulate food intake in relation to daily energy expenditure. In combination with the Polar M400's capabilities, a twice-weekly Facebook-delivered Social Cognitive Theory-based health intervention may be able to increase college students' self-efficacy, outcome expectancy, enjoyment, and social support while decreasing barriers for participation in greater physical activity and nutritious eating behaviors. Relatedly, it is vital to also examine the preceding intervention's ability to promote changes in college students' intrinsic motivation for these health behaviors-an investigation which can be completed via application of the Self-Determination Theory.

Eligibility criteria: Inclusion criteria:

* 18-29 years old
* Body mass index ≥ 18.5
* Is currently not engaging in physical activity levels above the Physical Activity Guidelines for Americans (PAGA; U.S. Department of Health and Human Services, 2008)-verified through a structured screening interview prior to participant recruitment and randomization
* Eats less than the recommended two serving of fruits and three serving of vegetables per day (USDA, 2015)-verified through screening using a 10-item fruit and vegetable food frequency questionnaire (F. Thompson et al., 2002)
* No self-reported diagnosed physical/mental disability
* Provides informed consent and completes the Physical Activity Readiness Questionnaire (PAR-Q)
* Willing to be randomized into an intervention or comparison group

Exclusion criteria:

* Self-reported diagnosed physical/mental disability
* Contraindication to physical activity participation as determined by PAR-Q results

Primary outcomes:
measure: Physical Activity
timeFrame: "Change in Physical Activity from Baseline to 6 Weeks" and "Change in Physical Activity from Baseline to 12 Weeks"
Secondary outcomes:
measure: Cardiovascular Fitness
timeFrame: "Change in Cardiovascular Fitness from Baseline to 12 Weeks"
measure: Body Composition
timeFrame: "Change in Body Composition from Baseline to 12 Weeks"
measure: Body Weight
timeFrame: "Change in Weight from Baseline to 12 Weeks"
measure: Self-Efficacy
timeFrame: "Change in Self-Efficacy from Baseline to 12 Weeks"
measure: Social Support
timeFrame: "Change in Social Support from Baseline to 12 Weeks"
measure: Enjoyment
timeFrame: "Change in Enjoyment from Baseline to 12 Weeks"
measure: Barriers
timeFrame: "Change in Barriers from Baseline to 12 Weeks"
measure: Outcome Expectancy
timeFrame: "Change in Outcome Expectancy from Baseline to 12 Weeks"
measure: Intrinsic Motivation
timeFrame: "Change in Intrinsic Motivation from Baseline to 12 Weeks"
measure: Nutritious Eating Behaviors
timeFrame: "Change in Nutritious Eating Behaviors from Baseline to 12 Weeks"
measure: Facebook-Delivered Health Intervention Adherence
timeFrame: "Assessed Weekly throughout 12-Week Intervention Period"
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Physical Activity Epidemiology Laboratory
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Zan Gao, PhD
role: PRINCIPAL_INVESTIGATOR
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