Location-based Smartphone Technology to Guide College Students Healthy Choices

• Sponsor: Klein Buendel, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02996864
• Collaborator: Pennington Biomedical Research Center (Other)
• Enrollment: 300
• Locations: 2
• Arms: 2
• Duration (Months): 29
• Patients Per Site: 150
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Health Behavior; Sleep Deprivation	Other: Healthy Detours App; Other: Fat Secret App	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Location-based Smartphone Technology to Guide College Students Healthy Choices Phase II
• Study Start Date: Sep 30, 2015
• Actual Primary Completion Date: Feb 28, 2018
• Actual Study Completion Date: Feb 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Detours App Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.	Other: 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.
Placebo Comparator: Fat Secret App Participants will be encouraged to use the FatSecret application daily to track food and physical activity.	Other: Fat Secret App; Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.

Outcome Measures

Primary Outcome Measures

1. Healthy Eating Index (HEI) [Baseline]

   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.

2. Healthy Eating Index (HEI) [6 weeks]

   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.

3. Healthy Eating Index (HEI) [12 weeks]

   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.

Secondary Outcome Measures

1. International Physical Activity Questionnaire Short-form (IPAQ-SF) [Baseline]

   A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at baseline. The IPAQ-SF calculates the MET-minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.

2. Physical Activity Measures [6 weeks]

   A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 6 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.

3. International Physical Activity Questionnaire Short-form (IPAQ-SF) [12 weeks]

   A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 12 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.

4. Sleep Quality [Baseline]

   The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (pre-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.

5. Sleep Quality [6 weeks]

   The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 6 weeks. The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.

6. Sleep Quality [12 weeks]

   The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 12 weeks (post-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.

7. Quality of Life (QOL) [Baseline]

   The 12-Item Short Form Health Survey (SF-12) will be administered at baseline (pre-test). The SF-12 survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.

8. Quality of Life (QOL) [6 weeks]

   The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.

9. Quality of Life (QOL) [12 weeks]

   The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klein Buendel, Inc.	Golden	Colorado	United States	80401
2	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70803

Sponsors and Collaborators

• Klein Buendel, Inc.
• Pennington Biomedical Research Center

Investigators

• Principal Investigator: Valerie Myers, PhD, Klein Buendel, Inc.

Study Documents (Full-Text)

• Study Protocol - Aug 16, 2016
• Statistical Analysis Plan - Aug 16, 2016

More Information

Publications

• 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.
• Curcio G, Ferrara M, De Gennaro L. Sleep loss, learning capacity and academic performance. Sleep Med Rev. 2006 Oct;10(5):323-37. Epub 2006 Mar 24. Review.
• 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.
• 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.
• 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.
• 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.
• Kopelman P. Health risks associated with overweight and obesity. Obes Rev. 2007 Mar;8 Suppl 1:13-7. Review.
• Kwan M, Faulkner G. Perceptions and barriers to physical activity during the transition to university. American Journal of Health Studies. 2011;26:87-96.
• 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. Review.
• 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.
• 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.
• 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.
• Salcedo Aguilar F, Rodríguez Almonacid FM, Monterde Aznar ML, García Jiménez MA, Redondo Martínez P, Marcos Navarro AI. [Sleeping habits and sleep disorders during adolescence: relation to school performance]. Aten Primaria. 2005 May 15;35(8):408-14. Spanish.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Klein Buendel, Inc.
• ClinicalTrials.gov Identifier: NCT02996864
• Other Study ID Numbers: 2R44DP004995; 0304
• First Posted: Dec 19, 2016
• Last Update Posted: Jul 8, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Klein Buendel, Inc.: college students; physical activity; sleep behaviors; diet
• Additional relevant MeSH terms: Sleep Deprivation; Overweight

Study Results

Participant Flow

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Period Title: Overall Study
STARTED	150	150
COMPLETED	142	136
NOT COMPLETED	8	14

Baseline Characteristics

Arm/Group Title	Healthy Detours App	Fat Secret App	Total
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.	Total of all reporting groups
Overall Participants	150	150	300
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.29 (2.66)	21.97 (3.03)	21.63 (2.87)
Sex: Female, Male (Count of Participants)
Female	112 74.7%	104 69.3%	216 72%
Male	38 25.3%	46 30.7%	84 28%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 1.3%	2 0.7%
Asian	16 10.7%	23 15.3%	39 13%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	13 8.7%	6 4%	19 6.3%
White	109 72.7%	106 70.7%	215 71.7%
More than one race	8 5.3%	6 4%	14 4.7%
Unknown or Not Reported	4 2.7%	7 4.7%	11 3.7%
Region of Enrollment (participants) [Number]
United States	150 100%	150 100%	300 100%

Outcome Measures

1. Primary Outcome

Title	Healthy Eating Index (HEI)
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	148	147
Mean (Standard Deviation) [units on a scale]	52.6 (15.1)	53.8 (14.6)

2. Primary Outcome

Title	Healthy Eating Index (HEI)
Description	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.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	106	96
Mean (Standard Deviation) [units on a scale]	50.9 (16.4)	52.3 (14.5)

3. Primary Outcome

Title	Healthy Eating Index (HEI)
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	141	137
Mean (Standard Deviation) [units on a scale]	51.3 (15.2)	52.1 (15.0)

4. Secondary Outcome

Title	International Physical Activity Questionnaire Short-form (IPAQ-SF)
Description	A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at baseline. The IPAQ-SF calculates the MET-minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	150	150
Mean (Standard Deviation) [MET minutes a week]	2222.9 (1713.3)	2521.3 (1914.2)

5. Secondary Outcome

Title	Physical Activity Measures
Description	A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 6 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	109	102
Mean (Standard Deviation) [MET minutes a week]	2467.8 (1981.4)	2104.1 (1943.4)

6. Secondary Outcome

Title	International Physical Activity Questionnaire Short-form (IPAQ-SF)
Description	A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 12 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	142	137
Mean (Standard Deviation) [MET minutes a week]	2231.5 (2013.8)	2016.84 (1830.2)

7. Secondary Outcome

Title	Sleep Quality
Description	The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (pre-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	150	150
Mean (Standard Deviation) [units on a scale]	5.8 (2.8)	5.5 (2.7)

8. Secondary Outcome

Title	Sleep Quality
Description	The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 6 weeks. The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	109	102
Mean (Standard Deviation) [units on a scale]	6.1 (3.1)	5.1 (2.8)

9. Secondary Outcome

Title	Sleep Quality
Description	The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 12 weeks (post-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	142	137
Mean (Standard Deviation) [units on a scale]	6.0 (3.2)	5.0 (2.8)

10. Secondary Outcome

Title	Quality of Life (QOL)
Description	The 12-Item Short Form Health Survey (SF-12) will be administered at baseline (pre-test). The SF-12 survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	150	150
Mean (Standard Deviation) [units on a scale]	52.9 (6.1)	53.1 (6.1)

11. Secondary Outcome

Title	Quality of Life (QOL)
Description	The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	109	102
Mean (Standard Deviation) [units on a scale]	53.5 (6.4)	53.9 (6.0)

12. Secondary Outcome

Title	Quality of Life (QOL)
Description	The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Detours App	Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.	Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Measure Participants	142	137
Mean (Standard Deviation) [units on a scale]	53.8 (6.0)	54.3 (5.5)

Adverse Events

Time Frame	12 months
Arm/Group Title	Healthy Detours App		Fat Secret App
Arm/Group Description	Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. 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.		Participants will be encouraged to use the FatSecret application daily to track food and physical activity. Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
All Cause Mortality
	Healthy Detours App		Fat Secret App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/150 (0%)
Serious Adverse Events
	Healthy Detours App		Fat Secret App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/150 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Detours App		Fat Secret App
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/150 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.