Dietary HabitsNCT02206893
Evaluating Consumer m-Health Services for User Engagement and Health Promotion: An Organizational Field Experiment
A study testing Self-monitoring via Smartphone, Peer support via Smartphone and Professional support via Smartphone in people with Dietary Habits and Compliance Behavior, run by Carnegie Mellon University at 1 site in United States.
Trial summary
Introduction Chronic disease is prevalent and costly in the U.S. (Tu \& Cohen, 2009). Poor eating habit is one factor that account for risk of chronic disease (Arsand, Varmedal, \& Hartvigsen, 2007). Smartphone technology has been promising to improve preventive health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Compliance Behavior
- What is being tested?
- Self-monitoring via Smartphone, Peer support via Smartphone and Professional support via Smartphone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age at least 18 years
- Android smartphone users
- having internet accessibility on the smartphone during the study period
Who cannot join
- currently participating in other similar programs
- having specific medical conditions that require specialized diets
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
Introduction Chronic disease is prevalent and costly in the U.S. (Tu \& Cohen, 2009). Poor eating habit is one factor that account for risk of chronic disease (Arsand, Varmedal, \& Hartvigsen, 2007). Smartphone technology has been promising to improve preventive health outcomes. However, its great potential has not been widely applied to people's eating behaviors and its impact is unknown.
Professional and peer supports can improve health status (Elkjaer et al., 2010; Lorig et al., 1999; Perri, Sears, \& Clark, 1993). However, the former is usually delivered didactically or passively with limited use of smartphones. There is also little evidence of the effect of peer support delivered by smartphones in the domain of healthy eating. This research aims to study what smartphone technology can do to upgrade professional and peer supports, and to evaluate the impact of these mobile-app enabled supports on people's behavior of healthy eating and user engagement.
Read more
Hypotheses
According to Social Cognitive Theory, we hypothesize the following:
- Mobile-enabled self-monitoring approach improves users' healthy eating behaviors through improved self-efficacy
- Professional support improves users' healthy eating behaviors through improved self-efficacy
- Peer support improves users' healthy eating behaviors through improved self-efficacy
- The amount of support is positively correlated with the change in behaviors and their determinants
Experiment Design The hypotheses will be examined bya 4-month randomized field experiment. 375 subjects will be recruited and assigned to one of the five arms to receive the corresponding tool for diet management at no cost.
Arm 1: a mobile App with both professional and peer support Arm 2: a mobile App with peer support only Arm 3: a mobile App with professional support only Arm 4: a mobile App without any support Arm 5: a non-mobile web App In addition to the App usage data, five surveys are conducted at baseline and the end of each month. Respondents will be compensated by $8 and a chance to win $200 for each completed survey.
Interventions
- All subjects receive the following interventions: an education package includes the importance of healthy eating, concept of MyPlate, personalized daily food plans; reminders throughout the study; goal setting capabilities;
- Self-monitoring provided by an Android App: a heuristic approach inspired by MyPlate to record their food consumption which allows users to record their meals by images and doesn't require estimations in cups and ounces; daily reports and trend reports
- Self-monitoring provided by the web App: a traditional approach to record their food consumption which requires estimations in cups and ounces, and no images are allowed; no daily reports and trend reports are provided
- Professional support provided by a registered dietitian via the Android App: the supports include the following:
- Reply to users' messages regarding healthy eating
- Provide meal-specific comments on subjects' meal consumptions: one meal per week
- Provide feedback on the subjects' consumption patterns: once per week
- Peer support provided by other subjects via the Android App: the App provides platforms for subjects who have the same interest to communicate to each other. The actions the subjects can do in the platforms include:
- Post images or texts related to healthy eating
- Share meals with their ratings
- Like/dislike others' posts
- Comment on others' posts e Create groups which allow subjects who have the same interest to join
Measurements
- Dependent Variables
- Eating behavior: a score of healthiness of a meal will be assigned by a dietitian. The scores obtained by the same subject along the experiment compose the subject's eating behavior
- Engaging behavior: this is measured by the number of meals recorded by the subject in a week. The numbers for the same subject along the experiment compose the subject's engaging behavior
- Independent Variables
- Level of peer support: this will be measured by a score representing the number of posts, likes, and comments received and given by a subject in a week
- Level of professional support: this will be measured by a score representing the number of messages or comments exchanged with the dietitian in a week
- Mediator Variables: self-efficacy, outcome expectation, and impediments will be measured by survey instruments
Data
- User Survey: characteristics and perceptions
- Mobile App: time, location, and contents of goal setting, meal entries, communications with professionals and peers
- Web App: contents of goal setting and meal entries
Analysis Confirmatory factor analysis and statistical modeling such as structural equation modeling and mixed models will be conducted to test our hypotheses.
- Conditions
- Dietary Habits, Compliance Behavior
- Being tested
- Self-monitoring via Smartphone, Peer support via Smartphone, Professional support via Smartphone, Self-monitoring via Web (Static)
- Medical subject headings
- Feeding Behavior, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoring via SmartphoneBehavioural
Peer support via SmartphoneBehavioural
Professional support via SmartphoneBehavioural
Self-monitoring via Web (Static)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Mobile: Professional and peer support | Experimental | A mobile app that provides both professional support and peer support Receives: Behavioral: Self-monitoring via Smartphone; Behavioral: Peer support via Smartphone; Behavioral: Professional support via Smartphone |
| Mobile: Peer support | Experimental | A mobile app that provides peer support, but not professional support Receives: Behavioral: Self-monitoring via Smartphone; Behavioral: Peer support via Smartphone |
| Mobile: Professional Support | Experimental | A mobile app that provides professional support, but no peer support Receives: Behavioral: Self-monitoring via Smartphone; Behavioral: Professional support via Smartphone |
| Mobile: No Support | Active comparator | A mobile app that provides neither peer support nor professional support Receives: Behavioral: Self-monitoring via Smartphone |
| Web: No Support | Active comparator | A web app that provides neither peer support, nor professional support Receives: Behavioral: Self-monitoring via Web (Static) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Eating Behavior
This will be measured by a score representing the healthiness of each selected meal, evaluated by dietitians. Specifically, the score is composed of three sub-scores: 1) portion of fruits and vegetables (7-point Likert scale); 2) portion of the entire meal (7-point Likert scale); 3) evaluators confidence level (4-point Likert scale). One subject will get one score per week, and hence 16 scores in 4-months.
Measured: 4 months after signed up
Engaging Behavior
This will be measured by the number of records submitted by the subject via the assigned tool in a week. One subject will get one score per week, and hence 16 scores in 4-months.
Measured: 4 months after signed up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Chin Lin, Carnegie Mellon University
- Investigators
- Yi-Chin Lin, MS, Principal investigator, Carnegie Mellon UniversityRema Padman, PhD, Study chair, Carnegie Mellon UniversityJulie Downs, PhD, Study director, Carnegie Mellon UniversityVibhanshu Abhishek, PhD, Study director, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206893
- Sponsor's protocol ID
- HS14-249
- Status last verified
- Jul 2015
- First submitted
- 31 Jul 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
Publications
Kato-Lin YC, Padman R, Downs J, Abhishek V. Evaluating Consumer m-Health Services for Promoting Healthy Eating: A Randomized Field Experiment. AMIA Annu Symp Proc. 2015 Nov 5;2015:1947-56. eCollection 2015.
PubMed 26958294
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Consumer m-Health Services for User Engagement and Health Promotion: An Organizational Field Experiment
- ClinicalTrials.gov ID
- NCT02206893
- Acronym / sponsor ID
- HS14-249
- Conditions
- Dietary Habits, Compliance Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction Chronic disease is prevalent and costly in the U.S. (Tu \& Cohen, 2009). Poor eating habit is one factor that account for risk of chronic disease (Arsand, Varmedal, \& Hartvigsen, 2007). Smartphone technology has been promising to improve preventive health outcomes. However, its great potential has not been widely applied to people's eating behaviors and its impact is unknown.
Professional and peer supports can improve health status (Elkjaer et al., 2010; Lorig et al., 1999; Perri, Sears, \& Clark, 1993). However, the former is usually delivered didactically or passively with limited use of smartphones. There is also little evidence of the effect of peer support delivered by smartphones in the domain of healthy eating. This research aims to study what smartphone technology can do to upgrade professional and peer supports, and to evaluate the impact of these mobile-app enabled supports on people's behavior of healthy eating and user engagement.
Hypotheses
According to Social Cognitive Theory, we hypothesize the following:
- Mobile-enabled self-monitoring approach improves users' healthy eating behaviors through improved self-efficacy
- Professional support improves users' healthy eating behaviors through improved self-efficacy
- Peer support improves users' healthy eating behaviors through improved self-efficacy
- The amount of support is positively correlated with the change in behaviors and their determinants
Experiment Design The hypotheses will be examined bya 4-month randomized field experiment. 375 subjects will be recruited and assigned to one of the five arms to receive the corresponding tool for diet management at no cost.
Arm 1: a mobile App with both professional and peer support Arm 2: a mobile App with peer support only Arm 3: a mobile App with professional support only Arm 4: a mobile App without any support Arm 5: a non-mobile web App In addition to the App usage data, five surveys are conducted at baseline and the end of each month. Respondents will be compensated by $8 and a chance to win $200 for each completed survey.
Interventions
- All subjects receive the following interventions: an education package includes the importance of healthy eating, concept of MyPlate, personalized daily food plans; reminders throughout the study; goal setting capabilities;
- Self-monitoring provided by an Android App: a heuristic approach inspired by MyPlate to record their food consumption which allows users to record their meals by images and doesn't require estimations in cups and ounces; daily reports and trend reports
- Self-monitoring provided by the web App: a traditional approach to record their food consumption which requires estimations in cups and ounces, and no images are allowed; no daily reports and trend reports are provided
- Professional support provided by a registered dietitian via the Android App: the supports include the following:
- Reply to users' messages regarding healthy eating
- Provide meal-specific comments on subjects' meal consumptions: one meal per week
- Provide feedback on the subjects' consumption patterns: once per week
- Peer support provided by other subjects via the Android App: the App provides platforms for subjects who have the same interest to communicate to each other. The actions the subjects can do in the platforms include:
- Post images or texts related to healthy eating
- Share meals with their ratings
- Like/dislike others' posts
- Comment on others' posts e Create groups which allow subjects who have the same interest to join
Measurements
- Dependent Variables
- Eating behavior: a score of healthiness of a meal will be assigned by a dietitian. The scores obtained by the same subject along the experiment compose the subject's eating behavior
- Engaging behavior: this is measured by the number of meals recorded by the subject in a week. The numbers for the same subject along the experiment compose the subject's engaging behavior
- Independent Variables
- Level of peer support: this will be measured by a score representing the number of posts, likes, and comments received and given by a subject in a week
- Level of professional support: this will be measured by a score representing the number of messages or comments exchanged with the dietitian in a week
- Mediator Variables: self-efficacy, outcome expectation, and impediments will be measured by survey instruments
Data
- User Survey: characteristics and perceptions
- Mobile App: time, location, and contents of goal setting, meal entries, communications with professionals and peers
- Web App: contents of goal setting and meal entries
Analysis Confirmatory factor analysis and statistical modeling such as structural equation modeling and mixed models will be conducted to test our hypotheses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mobile: Professional and peer support | Experimental | Behavioral: Self-monitoring via Smartphone, Behavioral: Peer support via Smartphone, Behavioral: Professional support via SmartphoneA mobile app that provides both professional support and peer support |
| Mobile: Peer support | Experimental | Behavioral: Self-monitoring via Smartphone, Behavioral: Peer support via SmartphoneA mobile app that provides peer support, but not professional support |
| Mobile: Professional Support | Experimental | Behavioral: Self-monitoring via Smartphone, Behavioral: Professional support via SmartphoneA mobile app that provides professional support, but no peer support |
| Mobile: No Support | Active comparator | Behavioral: Self-monitoring via SmartphoneA mobile app that provides neither peer support nor professional support |
| Web: No Support | Active comparator | Behavioral: Self-monitoring via Web (Static)A web app that provides neither peer support, nor professional support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age at least 18 years
- Android smartphone users
- having internet accessibility on the smartphone during the study period
Key exclusion criteria (2 listed)
- currently participating in other similar programs
- having specific medical conditions that require specialized diets
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 |
|---|---|---|
| Self-monitoring via Smartphone | Behavioural | Mobile: No Support, Mobile: Peer support, Mobile: Professional Support, Mobile: Professional and peer support |
| Peer support via Smartphone | Behavioural | Mobile: Peer support, Mobile: Professional and peer support |
| Professional support via Smartphone | Behavioural | Mobile: Professional Support, Mobile: Professional and peer support |
| Self-monitoring via Web (Static) | Behavioural | Web: No Support |
Primary outcome
Healthy Eating Behavior
Time frame: 4 months after signed up
This will be measured by a score representing the healthiness of each selected meal, evaluated by dietitians. Specifically, the score is composed of three sub-scores: 1) portion of fruits and vegetables (7-point Likert scale); 2) portion of the entire meal (7-point Likert scale); 3) evaluators confidence level (4-point Likert scale). One subject will get one score per week, and hence 16 scores in 4-months.
Engaging Behavior
Time frame: 4 months after signed up
This will be measured by the number of records submitted by the subject via the assigned tool in a week. One subject will get one score per week, and hence 16 scores in 4-months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Derived from this study: PubMed 26958294Kato-Lin YC, Padman R, Downs J, Abhishek V. Evaluating Consumer m-Health Services for Promoting Healthy Eating: A Randomized Field Experiment. AMIA Annu Symp Proc. 2015 Nov 5;2015:1947-56. eCollection 2015.
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Dietary Habits
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.
Yi-Chin Lin, MS principal investigator
Carnegie Mellon University
Rema Padman, PhD study chair
Carnegie Mellon University
Julie Downs, PhD study director
Carnegie Mellon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring via Smartphone, Peer support via Smartphone and Professional support via Smartphone in people with Dietary Habits and Compliance Behavior, run by Carnegie Mellon University at 1 site 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 3 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 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Behavior (time frame: 4 months after signed up). The study lists 2 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 NCT02206893, which also lists 1 linked publication.
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 28 Jul 2015.