Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II

February 2, 2023 updated by: Klein Buendel, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Klein Buendel, Inc.
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70803
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
6 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire Short-form (IPAQ-SF)
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.
Baseline
Physical Activity Measures
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.
6 weeks
International Physical Activity Questionnaire Short-form (IPAQ-SF)
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.
12 weeks
Sleep Quality
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.
Baseline
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.
6 weeks
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.
12 weeks
Quality of Life (QOL)
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.
Baseline
Quality of Life (QOL)
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.
6 weeks
Quality of Life (QOL)
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klein Buendel, Inc.

Collaborators

Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 30, 2015

Primary Completion (ACTUAL)

February 28, 2018

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (ESTIMATE)

December 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0304
  • 2R44DP004995 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Deprivation

Clinical Trials on Healthy Detours App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe