Health Behavior, Overweight and Obesity, Sleep Deprivation
Conditions
Keywords
college students, physical activity, sleep behaviors, diet
Brief summary
College students are in a newly independent phase of life; many of whom encounter unhealthy dietary decision- making, barriers to physical activity, and poor sleep behaviors. Healthy Detours is a location-based smartphone application tailored in real-time to a student's schedule and locale, and aims to guide students toward healthier eating, exercise, and lifestyle choices as a way to prevent the onset of damaging and costly health outcomes. Through a randomized control trial, this Phase II project will test the effectiveness of an evidence-based smartphone application that will provide students with on-demand, location-specific information about healthy lifestyle choices.
Detailed description
Poor eating habits, sedentary behavior, and deficient sleep quality are problematic for many college students. Surrounded by numerous unhealthy food choices and physical activity barriers, students are vulnerable to overweight and chronic diseases such as diabetes, heart disease, and cancer. Today's college students are more technologically connected than previous generations positioning mobile devices as an ideal method for reaching this population with healthy lifestyle information. In a Phase I Small Business Innovation Research (SBIR), our team developed Healthy Detours, an innovative mobile phone application (app) designed to assist college students make healthier choices about food and physical activity on and around their college campus. Specifically, we (a) developed a comprehensive database to provide user-specific information through the use of location-based services (LBS) focused on healthy lifestyle choices; (b) conducted an online survey with a national sample of undergraduates which examined eating and physical activity preferences, interest in smartphone technology to monitor healthy lifestyle choices, and use of check-ins for health information; (c) conducted focus groups which demonstrated the prototype app's ability to provide the user with rudimentary aspects of the LBS database to facilitate real-time decision making for healthier choices; (d) conducted lab and field usability testing of the app for its accuracy in identifying user location and functionality; and (e) developed a specifications document to outline the Phase II development plan. The results of the Phase I activities provided strong support for this project in which we propose to develop an interactive, mobile app that is guided by the Theory of Planned Behavior (TPB) and Social Cognitive Theory (SCT). This project will produce a fully functional LBS smartphone app that will provide (1) immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors, (2) person- and location-specific tailored data, acquired through activity tracking, to provide users with necessary information to improve future decision-making, and (3) multiple health-tracking features that will aid in self-monitoring. Healthy Detours will be evaluated in a randomized controlled trial (n=300) with students at a large 4-year university. Primary outcomes include changes in dietary intake, physical activity behavior, sleep quality, and quality of life. Overall, the proposed project has the potential to significantly impact college students' health and quality of life by providing them with real-time healthy choices. Healthy Detours is one of the first comprehensive wellness apps offered to college students, and provides an opportunity via the SBIR funding mechanism to reach a large number of students as evidenced by the commercialization plan.
Interventions
OTHERHealthy 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.
OTHERFat Secret App
Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
Sponsors
Pennington Biomedical Research Center
Klein Buendel, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Detours App 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. | 150 |
| Fat Secret App 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. | 150 |
| Total | 300 |
Baseline characteristics
| Characteristic | Healthy Detours App | Total | Fat Secret App |
|---|---|---|---|
| Age, Continuous | 21.29 years STANDARD_DEVIATION 2.66 | 21.63 years STANDARD_DEVIATION 2.87 | 21.97 years STANDARD_DEVIATION 3.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 39 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 19 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) White | 109 Participants | 215 Participants | 106 Participants |
| Region of Enrollment United States | 150 participants | 300 participants | 150 participants |
| Sex: Female, Male Female | 112 Participants | 216 Participants | 104 Participants |
| Sex: Female, Male Male | 38 Participants | 84 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 0 / 150 | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Healthy Eating Index (HEI) | 51.3 units on a scale | Standard Deviation 15.2 |
| Fat Secret App | Healthy Eating Index (HEI) | 52.1 units on a scale | Standard Deviation 15 |
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Healthy Eating Index (HEI) | 52.6 units on a scale | Standard Deviation 15.1 |
| Fat Secret App | Healthy Eating Index (HEI) | 53.8 units on a scale | Standard Deviation 14.6 |
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Healthy Eating Index (HEI) | 50.9 units on a scale | Standard Deviation 16.4 |
| Fat Secret App | Healthy Eating Index (HEI) | 52.3 units on a scale | Standard Deviation 14.5 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | International Physical Activity Questionnaire Short-form (IPAQ-SF) | 2222.9 MET minutes a week | Standard Deviation 1713.3 |
| Fat Secret App | International Physical Activity Questionnaire Short-form (IPAQ-SF) | 2521.3 MET minutes a week | Standard Deviation 1914.2 |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | International Physical Activity Questionnaire Short-form (IPAQ-SF) | 2231.5 MET minutes a week | Standard Deviation 2013.8 |
| Fat Secret App | International Physical Activity Questionnaire Short-form (IPAQ-SF) | 2016.84 MET minutes a week | Standard Deviation 1830.2 |
Secondary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Physical Activity Measures | 2467.8 MET minutes a week | Standard Deviation 1981.4 |
| Fat Secret App | Physical Activity Measures | 2104.1 MET minutes a week | Standard Deviation 1943.4 |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Quality of Life (QOL) | 53.8 units on a scale | Standard Deviation 6 |
| Fat Secret App | Quality of Life (QOL) | 54.3 units on a scale | Standard Deviation 5.5 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Quality of Life (QOL) | 52.9 units on a scale | Standard Deviation 6.1 |
| Fat Secret App | Quality of Life (QOL) | 53.1 units on a scale | Standard Deviation 6.1 |
Secondary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Quality of Life (QOL) | 53.5 units on a scale | Standard Deviation 6.4 |
| Fat Secret App | Quality of Life (QOL) | 53.9 units on a scale | Standard Deviation 6 |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Sleep Quality | 5.8 units on a scale | Standard Deviation 2.8 |
| Fat Secret App | Sleep Quality | 5.5 units on a scale | Standard Deviation 2.7 |
Secondary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Sleep Quality | 6.1 units on a scale | Standard Deviation 3.1 |
| Fat Secret App | Sleep Quality | 5.1 units on a scale | Standard Deviation 2.8 |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Detours App | Sleep Quality | 6.0 units on a scale | Standard Deviation 3.2 |
| Fat Secret App | Sleep Quality | 5.0 units on a scale | Standard Deviation 2.8 |