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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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:

  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:
  5. Reply to users' messages regarding healthy eating
  6. Provide meal-specific comments on subjects' meal consumptions: one meal per week
  7. Provide feedback on the subjects' consumption patterns: once per week
  8. 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:
  9. Post images or texts related to healthy eating
  10. Share meals with their ratings
  11. Like/dislike others' posts
  12. Comment on others' posts e Create groups which allow subjects who have the same interest to join

Measurements

  1. Dependent Variables
  2. 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
  3. 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
  4. Independent Variables
  5. 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
  6. 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
  7. 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.

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 groups in NCT02206893
Study groupRoleWhat they receive
Mobile: Professional and peer supportExperimentalA 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 supportExperimentalA mobile app that provides peer support, but not professional support
Receives: Behavioral: Self-monitoring via Smartphone; Behavioral: Peer support via Smartphone
Mobile: Professional SupportExperimentalA mobile app that provides professional support, but no peer support
Receives: Behavioral: Self-monitoring via Smartphone; Behavioral: Professional support via Smartphone
Mobile: No SupportActive comparatorA mobile app that provides neither peer support nor professional support
Receives: Behavioral: Self-monitoring via Smartphone
Web: No SupportActive comparatorA 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.

  1. 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

  2. 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.

  1. First posted1 Aug 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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)
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

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.

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