NCT02206893

Brief 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. 1.Mobile-enabled self-monitoring approach improves users' healthy eating behaviors through improved self-efficacy
  2. 2.Professional support improves users' healthy eating behaviors through improved self-efficacy
  3. 3.Peer support improves users' healthy eating behaviors through improved self-efficacy
  4. 4.The amount of support is positively correlated with the change in behaviors and their determinants
  5. 5.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;
  6. 6.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
  7. 7.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
  8. 8.Professional support provided by a registered dietitian via the Android App: the supports include the following:
  9. 9.Reply to users' messages regarding healthy eating
  10. 10.Provide meal-specific comments on subjects' meal consumptions: one meal per week
  11. 11.Provide feedback on the subjects' consumption patterns: once per week
  12. 12.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:
  13. 13.Post images or texts related to healthy eating
  14. 14.Share meals with their ratings
  15. 15.Like/dislike others' posts
  16. 16.Comment on others' posts e Create groups which allow subjects who have the same interest to join
  17. 17.Dependent Variables
  18. 18.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
  19. 19.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
  20. 20.Independent Variables
  21. 21.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
  22. 22.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
  23. 23.Mediator Variables: self-efficacy, outcome expectation, and impediments will be measured by survey instruments
  24. 24.User Survey: characteristics and perceptions
  25. 25.Mobile App: time, location, and contents of goal setting, meal entries, communications with professionals and peers
  26. 26.Web App: contents of goal setting and meal entries

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

July 31, 2014

Last Update Submit

July 27, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (5)

Mobile: Professional and peer support

EXPERIMENTAL

A mobile app that provides both professional support and peer support

Behavioral: Self-monitoring via SmartphoneBehavioral: Peer support via SmartphoneBehavioral: Professional support via Smartphone

Mobile: Peer support

EXPERIMENTAL

A mobile app that provides peer support, but not professional support

Behavioral: Self-monitoring via SmartphoneBehavioral: Peer support via Smartphone

Mobile: Professional Support

EXPERIMENTAL

A mobile app that provides professional support, but no peer support

Behavioral: Self-monitoring via SmartphoneBehavioral: Professional support via Smartphone

Mobile: No Support

ACTIVE COMPARATOR

A mobile app that provides neither peer support nor professional support

Behavioral: Self-monitoring via Smartphone

Web: No Support

ACTIVE COMPARATOR

A web app that provides neither peer support, nor professional support

Behavioral: Self-monitoring via Web (Static)

Interventions

Mobile: No SupportMobile: Peer supportMobile: Professional SupportMobile: Professional and peer support
Mobile: Peer supportMobile: Professional and peer support
Mobile: Professional SupportMobile: Professional and peer support
Web: No Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age at least 18 years
  • Android smartphone users
  • having internet accessibility on the smartphone during the study period

You may not qualify if:

  • currently participating in other similar programs
  • having specific medical conditions that require specialized diets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding BehaviorPatient Compliance

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Yi-Chin Lin, MS

    Carnegie Mellon University

    PRINCIPAL INVESTIGATOR
  • Rema Padman, PhD

    Carnegie Mellon University

    STUDY CHAIR
  • Julie Downs, PhD

    Carnegie Mellon University

    STUDY DIRECTOR
  • Vibhanshu Abhishek, PhD

    Carnegie Mellon University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 1, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations