- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02206893
Evaluating Consumer m-Health Services for User Engagement and Health Promotion: An Organizational Field Experiment
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Carnegie Mellon University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age at least 18 years
- Android smartphone users
- having internet accessibility on the smartphone during the study period
Exclusion Criteria:
- currently participating in other similar programs
- having specific medical conditions that require specialized diets
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile: Professional and peer support
A mobile app that provides both professional support and peer support
|
|
|
Experimental: Mobile: Peer support
A mobile app that provides peer support, but not professional support
|
|
|
Experimental: Mobile: Professional Support
A mobile app that provides professional support, but no peer support
|
|
|
Active Comparator: Mobile: No Support
A mobile app that provides neither peer support nor professional support
|
|
|
Active Comparator: Web: No Support
A web app that provides neither peer support, nor professional support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 months after signed up
|
|
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.
|
4 months after signed up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yi-Chin Lin, MS, Carnegie Mellon University
- Study Chair: Rema Padman, PhD, Carnegie Mellon University
- Study Director: Julie Downs, PhD, Carnegie Mellon University
- Study Director: Vibhanshu Abhishek, PhD, Carnegie Mellon University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HS14-249
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 Dietary Habits
-
Brown UniversityNational Cancer Institute (NCI); University of ConnecticutCompletedDietary Habits | Dietary Modification
-
University of ReadingUnknownDietary Habits | Dietary ModificationUnited Kingdom
-
University of ReadingCompletedDietary Habits | Dietary ModificationUnited Kingdom
-
Dawn BrewerNational Institute of Environmental Health Sciences (NIEHS)Completed
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI); Robert Wood Johnson FoundationCompleted
-
Florida Atlantic UniversityCompleted
-
Albert Einstein Healthcare NetworkAramark HealthcareCompletedDietary HabitsUnited States
-
Materno-Perinatal Hospital of the State of MexicoNational Council of Science and Technology, Mexico; Secretariat of Public Education...CompletedDietary HabitsMexico
-
Université Sorbonne Paris NordNot yet recruiting
-
Boston UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDietary HabitsUnited States
Clinical Trials on Self-monitoring via Smartphone
-
Murad AlrashidiNot yet recruitingPalatal Expansion Technique | Orthodontics, Interceptive | TeledentistrySaudi Arabia
-
University Rovira i VirgiliMinistry of Science and Innovation, SpainNot yet recruiting
-
Education University of Hong KongNot yet recruitingSmartphone Addiction | Attention Deficit Hyerpactivity Disorder
-
University of ConnecticutNational Heart, Lung, and Blood Institute (NHLBI); Worcester Polytechnic InstituteCompleted
-
Second Affiliated Hospital, School of Medicine,...Shaoxing Gaobu Street Community Health Service Center; Shaoxing Mashan Street... and other collaboratorsCompletedStroke | Cognitive Impairment | DementiaChina
-
THYROSCOPE INC.Not yet recruitingGraves Ophthalmopathy | Thyroid Associated Ophthalmopathies | Thyroid Eye Disease (TED)United States
-
Norwegian University of Science and TechnologyUllevaal University HospitalTerminated
-
Groupe Hospitalier Paris Saint JosephCompletedCoagulation DisorderFrance
-
Baylor Research InstituteNot yet recruitingColorectal Cancer (CRC) ScreeningUnited States
-
Alain NordmannTerminated