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
Verified date | October 2019 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Physical Activity Epidemiology Laboratory | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Aandstad A, Holtberget K, Hageberg R, Holme I, Anderssen SA. Validity and reliability of bioelectrical impedance analysis and skinfold thickness in predicting body fat in military personnel. Mil Med. 2014 Feb;179(2):208-17. doi: 10.7205/MILMED-D-12-00545. — View Citation
Bandura A. Social cognitive theory of self-regulation. Organizational Behavior and Human Decision Processes 50: 248-287, 1991.
Carlson JA, Sallis JF, Wagner N, Calfas KJ, Patrick K, Groesz LM, Norman GJ. Brief physical activity-related psychosocial measures: reliability and construct validity. J Phys Act Health. 2012 Nov;9(8):1178-86. Epub 2011 Dec 27. — View Citation
Deci EL, Eghrari H, Patrick BC, Leone DR. Facilitating internalization: the self-determination theory perspective. J Pers. 1994 Mar;62(1):119-42. — View Citation
Desai MN, Miller WC, Staples B, Bravender T. Risk factors associated with overweight and obesity in college students. J Am Coll Health. 2008 Jul-Aug;57(1):109-14. doi: 10.3200/JACH.57.1.109-114. — View Citation
Golding L, Meyers C, Sinning W. Y's way to physical fitness: the complete guide to fitness testing and instruction (4th ed.). Champaign, IL: Human Kinetics. 1998
Harter S. Effectance motivation reconsidered: toward a developmental model. Human Development. 1978, 21:34-64.
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
Levitsky DA, Halbmaier CA, Mrdjenovic G. The freshman weight gain: a model for the study of the epidemic of obesity. Int J Obes Relat Metab Disord. 2004 Nov;28(11):1435-42. — View Citation
McAuley E, Duncan T, Tammen VV. Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport. 1989 Mar;60(1):48-58. — View Citation
Millen BE, Abrams S, Adams-Campbell L, Anderson CA, Brenna JT, Campbell WW, Clinton S, Hu F, Nelson M, Neuhouser ML, Perez-Escamilla R, Siega-Riz AM, Story M, Lichtenstein AH. The 2015 Dietary Guidelines Advisory Committee Scientific Report: Development and Major Conclusions. Adv Nutr. 2016 May 16;7(3):438-44. doi: 10.3945/an.116.012120. Print 2016 May. Review. — View Citation
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
Sechrist KR, Walker SN, Pender NJ. Development and psychometric evaluation of the exercise benefits/barriers scale. Res Nurs Health. 1987 Dec;10(6):357-65. — View Citation
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
Trost SG, McIver KL, Pate RR. Conducting accelerometer-based activity assessments in field-based research. Med Sci Sports Exerc. 2005 Nov;37(11 Suppl):S531-43. Review. — View Citation
Trost SG, Pate RR, Saunders R, Ward DS, Dowda M, Felton G. A prospective study of the determinants of physical activity in rural fifth-grade children. Prev Med. 1997 Mar-Apr;26(2):257-63. — View Citation
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
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" |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Active, not recruiting |
NCT03903874 -
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Withdrawn |
NCT04540523 -
Home-Based Exergaming Intervention
|
N/A | |
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Completed |
NCT05019482 -
Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
|
N/A | |
Not yet recruiting |
NCT05985460 -
A Very Brief Intervention to Increase the Intention to Practice Physical Activity
|
N/A | |
Completed |
NCT03380143 -
Whole-of-Community Youth Population Physical Activity
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Completed |
NCT03170921 -
Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals
|
N/A | |
Completed |
NCT04973813 -
Active Choice Intervention About Physical Activity for Physically Inactive Adults
|
N/A | |
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Completed |
NCT03271112 -
Frailty Prevention in Elders From Reunion Island
|
N/A | |
Completed |
NCT05670223 -
Healthy Activities Improve Lives
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Recruiting |
NCT04578067 -
Empowering Immigrant Women for Active and Healthy Lifestyle
|
N/A | |
Completed |
NCT03297567 -
Physical Therapy Guidelines For Hospitalized Elderly
|
N/A | |
Completed |
NCT02869854 -
Increased Physical Activity Through Mindfulness
|
N/A |