Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II

NCT ID: NCT02996864

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-02-28

Brief Summary

College students are in a newly independent phase of life; many of whom encounter unhealthy dietary decision- making, barriers to physical activity, and poor sleep behaviors. Healthy Detours is a location-based smartphone application tailored in real-time to a student's schedule and locale, and aims to guide students toward healthier eating, exercise, and lifestyle choices as a way to prevent the onset of damaging and costly health outcomes. Through a randomized control trial, this Phase II project will test the effectiveness of an evidence-based smartphone application that will provide students with on-demand, location-specific information about healthy lifestyle choices.

Detailed Description

Poor eating habits, sedentary behavior, and deficient sleep quality are problematic for many college students. Surrounded by numerous unhealthy food choices and physical activity barriers, students are vulnerable to overweight and chronic diseases such as diabetes, heart disease, and cancer. Today's college students are more technologically connected than previous generations positioning mobile devices as an ideal method for reaching this population with healthy lifestyle information. In a Phase I Small Business Innovation Research (SBIR), our team developed Healthy Detours, an innovative mobile phone application (app) designed to assist college students make healthier choices about food and physical activity on and around their college campus. Specifically, we (a) developed a comprehensive database to provide user-specific information through the use of location-based services (LBS) focused on healthy lifestyle choices; (b) conducted an online survey with a national sample of undergraduates which examined eating and physical activity preferences, interest in smartphone technology to monitor healthy lifestyle choices, and use of "check-ins" for health information; (c) conducted focus groups which demonstrated the prototype app's ability to provide the user with rudimentary aspects of the LBS database to facilitate real-time decision making for healthier choices; (d) conducted lab and field usability testing of the app for its accuracy in identifying user location and functionality; and (e) developed a specifications document to outline the Phase II development plan. The results of the Phase I activities provided strong support for this project in which we propose to develop an interactive, mobile app that is guided by the Theory of Planned Behavior (TPB) and Social Cognitive Theory (SCT). This project will produce a fully functional LBS smartphone app that will provide (1) immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors, (2) person- and location-specific tailored data, acquired through activity tracking, to provide users with necessary information to improve future decision-making, and (3) multiple health-tracking features that will aid in self-monitoring. Healthy Detours will be evaluated in a randomized controlled trial (n=300) with students at a large 4-year university. Primary outcomes include changes in dietary intake, physical activity behavior, sleep quality, and quality of life. Overall, the proposed project has the potential to significantly impact college students' health and quality of life by providing them with real-time healthy choices. Healthy Detours is one of the first comprehensive wellness apps offered to college students, and provides an opportunity via the SBIR funding mechanism to reach a large number of students as evidenced by the commercialization plan.

Conditions

Overweight and Obesity; Health Behavior; Sleep Deprivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Healthy Detours App

Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.

Group Type: EXPERIMENTAL

Healthy Detours App

Intervention Type: OTHER

The app features:

• Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.
• User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.
• Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.

Fat Secret App

Participants will be encouraged to use the FatSecret application daily to track food and physical activity.

Group Type: PLACEBO_COMPARATOR

Fat Secret App

Intervention Type: OTHER

Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.

Interventions

Healthy Detours App

The app features:

• Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.
• User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.
• Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.

Intervention Type: OTHER

Fat Secret App

Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age 18-29
• enrolled in a university or college on the Denver Auraria campus or Louisiana State University (LSU) campus
• own a smartphone
• able to speak and read English; and
• consent to participate

Exclusion Criteria

• under age of 18 years
• not a current student at any Denver Auraria campus or at LSU

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: collaborator

Klein Buendel, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie Myers, PhD

Role: PRINCIPAL_INVESTIGATOR

Klein Buendel, Inc.

Locations

Klein Buendel, Inc.

Golden, Colorado, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

References

Cluskey M, Grobe D. College weight gain and behavior transitions: male and female differences. J Am Diet Assoc. 2009 Feb;109(2):325-9. doi: 10.1016/j.jada.2008.10.045.

Reference Type: BACKGROUND

PMID: 19167962 (View on PubMed)

Ferrara CM. The College Experience: Physical Activity, Nutrition, and Implications for Intervention and Future Research. Journal of Exercise Physiology online. 2009;12(1):23-35.

Reference Type: BACKGROUND

Hanson TL, Drumheller K, Mallard J, McKee C, Schlegel P. Cell phones, text messaging, and Facebook: competing time demands of today's college students. College Teaching. 2010;59(1):23-30.

Reference Type: BACKGROUND

Gaultney JF. The prevalence of sleep disorders in college students: impact on academic performance. J Am Coll Health. 2010;59(2):91-7. doi: 10.1080/07448481.2010.483708.

Reference Type: BACKGROUND

PMID: 20864434 (View on PubMed)

Laska MN, Pelletier JE, Larson NI, Story M. Interventions for weight gain prevention during the transition to young adulthood: a review of the literature. J Adolesc Health. 2012 Apr;50(4):324-33. doi: 10.1016/j.jadohealth.2012.01.016.

Reference Type: BACKGROUND

PMID: 22443834 (View on PubMed)

Li KK, Concepcion RY, Lee H, Cardinal BJ, Ebbeck V, Woekel E, Readdy RT. An examination of sex differences in relation to the eating habits and nutrient intakes of university students. J Nutr Educ Behav. 2012 May-Jun;44(3):246-50. doi: 10.1016/j.jneb.2010.10.002. Epub 2011 Jul 18.

Reference Type: BACKGROUND

PMID: 21764641 (View on PubMed)

Lloyd-Richardson EE, Bailey S, Fava JL, Wing R; Tobacco Etiology Research Network (TERN). A prospective study of weight gain during the college freshman and sophomore years. Prev Med. 2009 Mar;48(3):256-61. doi: 10.1016/j.ypmed.2008.12.009. Epub 2008 Dec 24.

Reference Type: BACKGROUND

PMID: 19146870 (View on PubMed)

Strong KA, Parks SL, Anderson E, Winett R, Davy BM. Weight gain prevention: identifying theory-based targets for health behavior change in young adults. J Am Diet Assoc. 2008 Oct;108(10):1708-1715. doi: 10.1016/j.jada.2008.07.007.

Reference Type: BACKGROUND

PMID: 18926139 (View on PubMed)

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. doi: 10.3200/JACH.53.6.245-251.

Reference Type: BACKGROUND

PMID: 15900988 (View on PubMed)

Zick CD, Smith KR, Brown BB, Fan JX, Kowaleski-Jones L. Physical activity during the transition from adolescence to adulthood. J Phys Act Health. 2007 Apr;4(2):125-37. doi: 10.1123/jpah.4.2.125.

Reference Type: BACKGROUND

PMID: 17570883 (View on PubMed)

Yeh MC, Matsumori B, Obenchain J, Viladrich A, Das D, Navder K. Validity of a competing food choice construct regarding fruit and vegetable consumption among urban college freshmen. J Nutr Educ Behav. 2010 Sep-Oct;42(5):321-7. doi: 10.1016/j.jneb.2009.08.004. Epub 2010 Jul 22.

Reference Type: BACKGROUND

PMID: 20655281 (View on PubMed)

Salcedo Aguilar F, Rodriguez Almonacid FM, Monterde Aznar ML, Garcia Jimenez MA, Redondo Martinez P, Marcos Navarro AI. [Sleeping habits and sleep disorders during adolescence: relation to school performance]. Aten Primaria. 2005 May 15;35(8):408-14. doi: 10.1157/13074792. Spanish.

Reference Type: BACKGROUND

PMID: 15882497 (View on PubMed)

Curcio G, Ferrara M, De Gennaro L. Sleep loss, learning capacity and academic performance. Sleep Med Rev. 2006 Oct;10(5):323-37. doi: 10.1016/j.smrv.2005.11.001. Epub 2006 Mar 24.

Reference Type: BACKGROUND

PMID: 16564189 (View on PubMed)

Trockel MT, Barnes MD, Egget DL. Health-related variables and academic performance among first-year college students: implications for sleep and other behaviors. J Am Coll Health. 2000 Nov;49(3):125-31. doi: 10.1080/07448480009596294.

Reference Type: BACKGROUND

PMID: 11125640 (View on PubMed)

Kwan M, Faulkner G. Perceptions and barriers to physical activity during the transition to university. American Journal of Health Studies. 2011;26:87-96.

Reference Type: BACKGROUND

Wengreen HJ, Moncur C. Change in diet, physical activity, and body weight among young-adults during the transition from high school to college. Nutr J. 2009 Jul 22;8:32. doi: 10.1186/1475-2891-8-32.

Reference Type: BACKGROUND

PMID: 19624820 (View on PubMed)

Hoffman DJ, Policastro P, Quick V, Lee SK. Changes in body weight and fat mass of men and women in the first year of college: A study of the "freshman 15". J Am Coll Health. 2006 Jul-Aug;55(1):41-5. doi: 10.3200/JACH.55.1.41-46.

Reference Type: BACKGROUND

PMID: 16889314 (View on PubMed)

Kopelman P. Health risks associated with overweight and obesity. Obes Rev. 2007 Mar;8 Suppl 1:13-7. doi: 10.1111/j.1467-789X.2007.00311.x. No abstract available.

Reference Type: BACKGROUND

PMID: 17316295 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2R44DP004995

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0304

Identifier Type: -

Identifier Source: org_study_id