Health Wearables and College Student Health

Physical Activity Clinical Trial

Official title:

Use of Health Wearables to Improve Physical Activity and Eating Behaviors Among College Students: A 12-week Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253406
• Other study ID #: STUDY00000386
• Status: Completed
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: May 7, 2018

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 7, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior Change
• Intervention
• Physical Activity
• Technology
• Young Adults

Intervention

Behavioral:
• Polar M400 + Facebook Group (PM400+FG)
Throughout the intervention period experimental group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page. Additionally, experimental group participants will be asked to track all physical activity with the Polar M400 smartwatch and use this information to set physical activity-related goals conducive to improved health.
• Facebook Only Group (FG)
Throughout the intervention period comparison group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page.

Locations

Country	Name	City	State
United States	Physical Activity Epidemiology Laboratory	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Kaminsky LA, Ozemek C. A comparison of the Actigraph GT1M and GT3X accelerometers under standardized and free-living conditions. Physiol Meas. 2012 Nov;33(11):1869-76. doi: 10.1088/0967-3334/33/11/1869. Epub 2012 Oct 31. — View Citation

Kipnis V, Subar AF, Midthune D, Freedman LS, Ballard-Barbash R, Troiano RP, Bingham S, Schoeller DA, Schatzkin A, Carroll RJ. Structure of dietary measurement error: results of the OPEN biomarker study. Am J Epidemiol. 2003 Jul 1;158(1):14-21; discussion 22-6. — View Citation

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Moshfegh AJ, Rhodes DG, Baer DJ, Murayi T, Clemens JC, Rumpler WV, Paul DR, Sebastian RS, Kuczynski KJ, Ingwersen LA, Staples RC, Cleveland LE. The US Department of Agriculture Automated Multiple-Pass Method reduces bias in the collection of energy intakes. Am J Clin Nutr. 2008 Aug;88(2):324-32. — View Citation

Nelson TF, Gortmaker SL, Subramanian SV, Cheung L, Wechsler H. Disparities in overweight and obesity among US college students. Am J Health Behav. 2007 Jul-Aug;31(4):363-73. — View Citation

Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732. — View Citation

Perrin A. Social media usage: 2005-2015. Available from http://www.pewinternet.org/2015/10/08/2015/Social-Networking-Usage-2005-2015/. 2015

Piwek L, Ellis DA, Andrews S, Joinson A. The Rise of Consumer Health Wearables: Promises and Barriers. PLoS Med. 2016 Feb 2;13(2):e1001953. doi: 10.1371/journal.pmed.1001953. eCollection 2016 Feb. Review. — View Citation

Racette SB, Deusinger SS, Strube MJ, Highstein GR, Deusinger RH. Weight changes, exercise, and dietary patterns during freshman and sophomore years of college. J Am Coll Health. 2005 May-Jun;53(6):245-51. — View Citation

Rodgers WM, Wilson PM, Hall CR, Fraser SN, Murray TC. Evidence for a multidimensional self-efficacy for exercise scale. Res Q Exerc Sport. 2008 Jun;79(2):222-34. — View Citation

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Silva MN, Vieira PN, Coutinho SR, Minderico CS, Matos MG, Sardinha LB, Teixeira PJ. Using self-determination theory to promote physical activity and weight control: a randomized controlled trial in women. J Behav Med. 2010 Apr;33(2):110-22. doi: 10.1007/s10865-009-9239-y. Epub 2009 Dec 11. — View Citation

Thompson FE, Subar AF, Smith AF, Midthune D, Radimer KL, Kahle LL, Kipnis V. Fruit and vegetable assessment: performance of 2 new short instruments and a food frequency questionnaire. J Am Diet Assoc. 2002 Dec;102(12):1764-72. — View Citation

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U.S. Department of Health and Human Services. 2008 physical activity guidelines for Americans. Available from https://health.gov/paguidelines/pdf/paguide.pdf. 2008.

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Will be assessed via Actigraph Link accelerometers with daily moderate-to-vigorous physical activity, light physical activity, sedentary behavior, steps per day, and energy expenditure the outcomes of interest. The Actigraph accelerometer has been validated among adults (Kaminsky & Ozemek, 2012). Participants will wear the accelerometer for seven days (ensuring the collection of physical activity data on at least two weekdays and one weekend day) as suggested for field-based accelerometer research (Trost, McIver, & Pate, 2005), with the accelerometer appended to the same wrist as the Polar M400. Accelerometry measurements will take place at baseline, six weeks, and 12 weeks to examine changes over time in the aforementioned outcomes.	"Change in Physical Activity from Baseline to 6 Weeks" and "Change in Physical Activity from Baseline to 12 Weeks"
Secondary	Cardiovascular Fitness	Evaluated with YMCA 3-minute step test (Golding, Meyers, & Sinning, 1998). Participants will step up and down for three minutes on a 12-inch riser to a metronome beep set at 96 beats per minute (each beep corresponding to one movement of the leg, with 4 beeps representing one "up-down" cycle). Participants' heart rate will be assessed immediately for one minute following the conclusion of the test by the researcher via palpation of the carotid/radial artery. The step test will be performed at baseline and 12 weeks to assess changes in cardiovascular fitness over time.	"Change in Cardiovascular Fitness from Baseline to 12 Weeks"
Secondary	Body Composition	Determined via bioelectrical impedance performed with the Tanita BC-558 IRONMAN® Segmental Body Composition Monitor (Tanita, Tokyo, Japan). Bioelectrical impedance sends a small electrical pulsatile wave through the body. Muscle is more conducive to electrical current transmission due to its higher water content versus fat meaning individuals with higher lean mass (i.e., lower body fat mass) will not impede the current to the degree of individuals with higher fat mass and therefore register lower body fat percentage values. Bioelectrical impedance has proven a valid measure of body composition in young adults enrolling in the military (Aandstad, Holtberget, Hageberg, Holme, & Anderssen, 2014). Notably, to decrease variability in these body composition measurements, individuals will be asked to come in for testing at approximately the same time of day and having eaten/drank similar foods/beverages the night before as they did prior to previous session(s).	"Change in Body Composition from Baseline to 12 Weeks"
Secondary	Body Weight	Body Weight will be assessed using a calibrated weight scale: the Tanita BC-558 IRONMAN® Segmental Body Composition Monitor (Tanita, Tokyo, Japan).	"Change in Weight from Baseline to 12 Weeks"
Secondary	Self-Efficacy	Self-efficacy will be measured by a nine-question measure developed by Rodgers, Wilson, Hall, Fraser, and Murray (2008) wherein participants will rate how confident they feel in certain exercise situations (e.g., …"exercise when you feel discomfort" or "…exercise when you lack energy") on a percentage scale (0%: not confident at all to 100%: extremely confident in 10% increments).	"Change in Self-Efficacy from Baseline to 12 Weeks"
Secondary	Social Support	Social support will be assessed using a five-question measure adapted from the Patient-Centered Assessment and Counseling for Exercise questionnaire, with participants rating on a five-point Likert-type scale (1: almost never to 5: almost always) how often significant others support/encourage them to be physically activity (Carlson et al., 2012).	"Change in Social Support from Baseline to 12 Weeks"
Secondary	Enjoyment	A 5-question measure developed by Harter et al. (1978) quantified PA enjoyment as college students noted agreement with statements such as "Engaging in physical activity is the thing I like to do best" on a 5-point Likert-type scale (1: strongly disagree to 5: strongly agree).	"Change in Enjoyment from Baseline to 12 Weeks"
Secondary	Barriers	A 14-question measure will evaluate participants' physical activity barriers, with participants asked to rate agreement between hypothetical barriers and their own barriers on a four-point Likert-type scale (1: strongly disagree to 4: strongly agree) (Sechrist, Walker, & Pender, 1987).	"Change in Barriers from Baseline to 12 Weeks"
Secondary	Outcome Expectancy	Outcome expectancy will be assessed with a nine-question measure developed by Trost et al. (1997) using a five-point Likert-type scale (1: strongly disagree to 5: strongly agree) to evaluate participants' agreement with responses originating from the stem "If I was to exercise on most days it would…". Sample responses are "give me more energy" and "help to control my weight".	"Change in Outcome Expectancy from Baseline to 12 Weeks"
Secondary	Intrinsic Motivation	Will be evaluated using the interest/enjoyment subscale of the Intrinsic Motivation Inventory (McAuley, Duncan, & Tammen, 1987). This seven-question subscale requires participants to determent how true certain statements such as "I enjoyed this activity very much" and "I would describe this activity as interesting" are to them on a seven-point Likert-type scale (1: not at all true to 7: very true). The Intrinsic Motivation Inventory has demonstrated good validity in the assessment of intrinsic motivation during exercise (Deci, Eghrari, Patrick, & Leone, 1994).	"Change in Intrinsic Motivation from Baseline to 12 Weeks"
Secondary	Nutritious Eating Behaviors	To assess participant eating behaviors, the National Cancer Institute's Automated Self-Administered (ASA) 24-hour Dietary Recall will be used requiring participants to recall all foods consumed within the past 24 hours. The ASA 24-hour Dietary Recall has been validated in previous research (Kipnis et al., 2003; Moshfegh et al., 2008). Participants will receive unique login information allowing them to access and complete the recall after which the researcher will be able to download and analyze the results. The ASA 24-hour Dietary recall will be administered three times on random dates during the seven days following baseline and post-intervention testing at 12 weeks, with participants notified during these testing sessions that they will be asked to complete this questionnaire. Concentration will be placed on examining changes in participants' fruit and vegetable consumption in addition to the participants' intake of fast food and sugar-sweetened beverages.	"Change in Nutritious Eating Behaviors from Baseline to 12 Weeks"
Secondary	Facebook-Delivered Health Intervention Adherence	Regardless of group allocation, adherence to the social media-delivered health intervention previously outlined will be tracked. Briefly, the researcher will determine whether the participants have checked the Facebook health tips twice weekly in two manners following the alert each participant will receive when a new post goes live on each groups' Facebook page. First, Facebook now has a "Seen By" function that automatically indicates and lists everyone who has interacted with a new posting within a private Facebook group. Second, the researcher will also ask participants to "Like" each of the postings they read. In this way, the researcher will keep a running tally of whether each participant checked the posting by reviewing the "Seen By" function and whether the individual "Liked" the posting. Only individuals listed both within the "Seen By" function and as having "Liked" the posting will be counted as having seen the health tips.	"Assessed Weekly throughout 12-Week Intervention Period"