Evaluating Consumer m‐Health Services for User Engagement and Health Promotion: An Organizational Field Experiment

Dietary Habits Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206893
• Other study ID #: HS14-249
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: July 27, 2015
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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:

1. Mobile-enabled self-monitoring approach improves users' healthy eating behaviors through improved self-efficacy

2. Professional support improves users' healthy eating behaviors through improved self-efficacy

3. Peer support improves users' healthy eating behaviors through improved self-efficacy

4. 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

1. 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;

2. 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

3. 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

4. Professional support provided by a registered dietitian via the Android App: the supports include the following:

1. Reply to users' messages regarding healthy eating

2. Provide meal-specific comments on subjects' meal consumptions: one meal per week

3. Provide feedback on the subjects' consumption patterns: once per week

5. 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:

1. Post images or texts related to healthy eating

2. Share meals with their ratings

3. Like/dislike others' posts

4. Comment on others' posts e Create groups which allow subjects who have the same interest to join

Measurements

1. Dependent Variables

1. 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

2. 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

2. Independent Variables

1. 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

2. 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

3. Mediator Variables: self-efficacy, outcome expectation, and impediments will be measured by survey instruments

Data

1. User Survey: characteristics and perceptions

2. Mobile App: time, location, and contents of goal setting, meal entries, communications with professionals and peers

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Compliance Behavior
• Dietary Habits

Intervention

Behavioral:
• Self-monitoring via Smartphone

• Peer support via Smartphone

• Professional support via Smartphone

• Self-monitoring via Web (Static)

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Carnegie Mellon University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months after signed up	No
Primary	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.	4 months after signed up	No