Trial Outcomes & Findings for Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II (NCT NCT02996864)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

Baseline

Results posted on

2023-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	150	150
Overall Study COMPLETED	142	136
Overall Study NOT COMPLETED	8	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Detours App n=150 Participants 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.	Fat Secret App n=150 Participants 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 n=300 Participants Total of all reporting groups
Age, Continuous	21.29 years STANDARD_DEVIATION 2.66 • n=5 Participants	21.97 years STANDARD_DEVIATION 3.03 • n=7 Participants	21.63 years STANDARD_DEVIATION 2.87 • n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	104 Participants n=7 Participants	216 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	46 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants	106 Participants n=7 Participants	215 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants	150 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=148 Participants 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.	Fat Secret App n=147 Participants 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.
Healthy Eating Index (HEI)	52.6 units on a scale Standard Deviation 15.1	53.8 units on a scale Standard Deviation 14.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=106 Participants 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.	Fat Secret App n=96 Participants 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.
Healthy Eating Index (HEI)	50.9 units on a scale Standard Deviation 16.4	52.3 units on a scale Standard Deviation 14.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=141 Participants 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.	Fat Secret App n=137 Participants 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.
Healthy Eating Index (HEI)	51.3 units on a scale Standard Deviation 15.2	52.1 units on a scale Standard Deviation 15.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=150 Participants 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.	Fat Secret App n=150 Participants 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.
International Physical Activity Questionnaire Short-form (IPAQ-SF)	2222.9 MET minutes a week Standard Deviation 1713.3	2521.3 MET minutes a week Standard Deviation 1914.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=109 Participants 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.	Fat Secret App n=102 Participants 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.
Physical Activity Measures	2467.8 MET minutes a week Standard Deviation 1981.4	2104.1 MET minutes a week Standard Deviation 1943.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=142 Participants 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.	Fat Secret App n=137 Participants 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.
International Physical Activity Questionnaire Short-form (IPAQ-SF)	2231.5 MET minutes a week Standard Deviation 2013.8	2016.84 MET minutes a week Standard Deviation 1830.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=150 Participants 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.	Fat Secret App n=150 Participants 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.
Sleep Quality	5.8 units on a scale Standard Deviation 2.8	5.5 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=109 Participants 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.	Fat Secret App n=102 Participants 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.
Sleep Quality	6.1 units on a scale Standard Deviation 3.1	5.1 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=142 Participants 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.	Fat Secret App n=137 Participants 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.
Sleep Quality	6.0 units on a scale Standard Deviation 3.2	5.0 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=150 Participants 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.	Fat Secret App n=150 Participants 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.
Quality of Life (QOL)	52.9 units on a scale Standard Deviation 6.1	53.1 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=109 Participants 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.	Fat Secret App n=102 Participants 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.
Quality of Life (QOL)	53.5 units on a scale Standard Deviation 6.4	53.9 units on a scale Standard Deviation 6.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Detours App n=142 Participants 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.	Fat Secret App n=137 Participants 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.
Quality of Life (QOL)	53.8 units on a scale Standard Deviation 6.0	54.3 units on a scale Standard Deviation 5.5

Adverse Events

Healthy Detours App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fat Secret App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Valerie Myers, PhD

Klein Buendel

Phone: 3035654343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place