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

July 27, 2015 updated by: Yi-Chin Lin, Carnegie Mellon University

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

425

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

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Carnegie Mellon University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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

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

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

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

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

March 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

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.

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