Overweight and ObesityNCT02996864
Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II
A study testing Healthy Detours App and Fat Secret App in people with Overweight and Obesity and Health Behavior, run by Klein Buendel, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Health Behavior, Sleep Deprivation
- What is being tested?
- Healthy Detours App and Fat Secret App
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2015to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- under age of 18 years
- not a current student at any Denver Auraria campus or at LSU
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70803
Klein Buendel, Inc.
Golden, Colorado, 80401
About this study
Official title: Location-based Smartphone Technology to Guide College Students Healthy Choices Phase II
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.
Read the 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
- Being tested
- Healthy Detours App, Fat Secret App
- Keywords
- college students, physical activity, sleep behaviors, diet
- Medical subject headings
- Overweight, Obesity, Health Behavior, Sleep Deprivation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Fat Secret AppOther
Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Detours App | Experimental | Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. Receives: 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. Receives: Other: Fat Secret App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (9)
International Physical Activity Questionnaire Short-form (IPAQ-SF)
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.
Measured: Baseline
Physical Activity Measures
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.
Measured: 6 weeks
International Physical Activity Questionnaire Short-form (IPAQ-SF)
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.
Measured: 12 weeks
Sleep Quality
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.
Measured: Baseline
Sleep Quality
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.
Measured: 6 weeks
Sleep Quality
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.
Measured: 12 weeks
Quality of Life (QOL)
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.
Measured: Baseline
Quality of Life (QOL)
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.
Measured: 6 weeks
Quality of Life (QOL)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start30 Sep 2015
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Valerie Myers, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996864
- Sponsor's protocol ID
- 0304
- Other IDs
- 2R44DP004995
- Status last verified
- Feb 2023
- First submitted
- 13 Dec 2016
- Last updated
- 6 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 19167962Ferrara CM. The College Experience: Physical Activity, Nutrition, and Implications for Intervention and Future Research. Journal of Exercise Physiology online. 2009;12(1):23-35.
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.
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.
PubMed 20864434Laska 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.
PubMed 22443834Li 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.
PubMed 21764641Lloyd-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.
PubMed 19146870Strong 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.
PubMed 18926139Racette 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.
PubMed 15900988Zick 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.
PubMed 17570883Yeh 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.
PubMed 20655281Salcedo 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.
PubMed 15882497Curcio 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.
PubMed 16564189Trockel 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.
PubMed 11125640Kwan M, Faulkner G. Perceptions and barriers to physical activity during the transition to university. American Journal of Health Studies. 2011;26:87-96.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Location-based Smartphone Technology to Guide College Students Healthy Choices Phase II
- ClinicalTrials.gov ID
- NCT02996864
- Acronym / sponsor ID
- 0304
- Conditions
- Overweight and Obesity, Health Behavior, Sleep Deprivation
- Keywords
- college students, physical activity, sleep behaviors, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pennington Biomedical Research Center
- Study start
- 30 Sep 2015
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Detours App | Experimental | Other: Healthy Detours AppParticipants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep. |
| Fat Secret App | Placebo comparator | Other: Fat Secret AppParticipants will be encouraged to use the FatSecret application daily to track food and physical activity. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- under age of 18 years
- not a current student at any Denver Auraria campus or at LSU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Detours AppThe 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. | Other | Healthy Detours App |
| Fat Secret AppFreely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting. | Other | Fat Secret App |
Primary outcome
Healthy Eating Index (HEI)
Time frame: 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.
Healthy Eating Index (HEI)
Time frame: 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.
Healthy Eating Index (HEI)
Time frame: 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.
9 secondary outcomes
International Physical Activity Questionnaire Short-form (IPAQ-SF)
Time frame: Baseline
Physical Activity Measures
Time frame: 6 weeks
International Physical Activity Questionnaire Short-form (IPAQ-SF)
Time frame: 12 weeks
Sleep Quality
Time frame: Baseline
Sleep Quality
Time frame: 6 weeks
Sleep Quality
Time frame: 12 weeks
Quality of Life (QOL)
Time frame: Baseline
Quality of Life (QOL)
Time frame: 6 weeks
Quality of Life (QOL)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19167962Cluskey 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.
- BackgroundFerrara CM. The College Experience: Physical Activity, Nutrition, and Implications for Intervention and Future Research. Journal of Exercise Physiology online. 2009;12(1):23-35.
- BackgroundHanson 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: PubMed 20864434Gaultney 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.
- Background: PubMed 22443834Laska 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.
- Background: PubMed 21764641Li 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.
- Background: PubMed 19146870Lloyd-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.
- Background: PubMed 18926139Strong 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.
- Background: PubMed 15900988Racette 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.
- Background: PubMed 17570883Zick 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.
- Background: PubMed 20655281Yeh 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.
- Background: PubMed 15882497Salcedo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Myers, PhD principal investigator
Klein Buendel, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Detours App and Fat Secret App in people with Overweight and Obesity and Health Behavior, run by Klein Buendel, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Eating Index (HEI) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02996864, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.