NCT02996864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

July 8, 2021

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

December 13, 2016

Results QC Date

July 25, 2018

Last Update Submit

February 2, 2023

Conditions

Overweight and ObesityHealth BehaviorSleep Deprivation

Keywords

college studentsphysical activitysleep behaviorsdiet

Outcome Measures

Primary Outcomes (3)

  • Healthy Eating Index (HEI)

    The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at baseline (pre-test) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.

    Baseline

  • Healthy Eating Index (HEI)

    The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 6-weeks) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.

    6 weeks

  • Healthy Eating Index (HEI)

    The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 12 weeks to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.

    12 weeks

Secondary Outcomes (9)

  • International Physical Activity Questionnaire Short-form (IPAQ-SF)

    Baseline

  • Physical Activity Measures

    6 weeks

  • International Physical Activity Questionnaire Short-form (IPAQ-SF)

    12 weeks

  • Sleep Quality

    Baseline

  • Sleep Quality

    6 weeks

  • +4 more secondary outcomes

Study Arms (2)

Healthy Detours App

EXPERIMENTAL

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

Other: Healthy Detours App

Fat Secret App

PLACEBO COMPARATOR

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

Other: Fat Secret App

Interventions

Healthy Detours AppOTHER

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.

Healthy Detours App
Fat Secret AppOTHER

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

Fat Secret App

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70803, United States

Location

Related Publications (18)

  • 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.

    PMID: 19167962BACKGROUND

  • 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.

    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.

    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.

    PMID: 20864434BACKGROUND

  • 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.

    PMID: 22443834BACKGROUND

  • 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.

    PMID: 21764641BACKGROUND

  • 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.

    PMID: 19146870BACKGROUND

  • 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.

    PMID: 18926139BACKGROUND

  • 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.

    PMID: 15900988BACKGROUND

  • 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.

    PMID: 17570883BACKGROUND

  • 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.

    PMID: 20655281BACKGROUND

  • 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.

    PMID: 15882497BACKGROUND

  • 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.

    PMID: 16564189BACKGROUND

  • 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.

    PMID: 11125640BACKGROUND

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

    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.

    PMID: 19624820BACKGROUND

  • 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.

    PMID: 16889314BACKGROUND

  • 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.

    PMID: 17316295BACKGROUND

MeSH Terms

Conditions

OverweightObesityHealth BehaviorSleep DeprivationMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsMental Disorders

Results Point of Contact

Title
Valerie Myers, PhD
Organization
Klein Buendel
vmyers@kleinbuendel.com
3035654343

Study Officials

  • Valerie Myers, PhD

    Klein Buendel, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 19, 2016

Study Start

September 30, 2015

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

February 6, 2023

Results First Posted

July 8, 2021

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)