NCT Number: NCT02996864
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.
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Notify Me18 year–29 year
All sexes
Interventional
Not applicable
Klein Buendel, Inc., Golden, Colorado, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The app features:
Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Klein Buendel, Inc.
Industry
Location-based Smartphone Technology to Guide College Students Healthy Choices Phase II
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