NCT03869658

Brief Summary

This project will pilot test a new app for self-monitoring food intake using natural spoken language (by voice recognition or text) to provide daily estimates of energy and nutrient intakes with a phone app.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

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

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 19, 2018

Last Update Submit

September 12, 2019

Conditions

Dietary Intake

Keywords

Voice recognition24-hr diet recallMobile applicationSelf-report

Outcome Measures

Primary Outcomes (2)

  • Change in energy intake using food application COCO

    The primary outcome will be to assess whether food capture using the mobile application is comparable with conventional 24-hour dietary recall. This will be done by measuring the energy intake (mean of two days) in the two methods.

    Between days 3 and 7 of the study

  • Change in energy intake using 24 hour dietary recall

    The primary outcome will be to assess whether food capture using the mobile application is comparable with conventional 24-hour dietary recall. This will be done by measuring the energy intake (mean of two days) in the two methods.

    Between days 3 and 7 of the study

Secondary Outcomes (1)

  • Accuracy of food capture method using mobile application

    Between days 3 and 7 of the study

Other Outcomes (1)

  • Application feasibility

    Betweens days 5 and 7

Interventions

COCO applicationBEHAVIORAL

All participants will complete a screening survey to determine their eligibility for the study, if eligible and willing to participate, he or she will sign an informed consent form. Once participants are enrolled in the study, a demographics questionnaire will be completed along with 5 days of food tracking on the COCO application. Between days 3 and 7, participants will complete two 24-hr diet recall, one a day, and a patient satisfaction questionnaire.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential subjects will be recruited from the local community around Boston, Massachusetts. Recruitment methods include posting flyers, social and local media advertisements, word of mouth, and emails to HNRCA mailing lists.

You may qualify if:

  • Generally healthy men and women 18-65 years if age
  • Currently participating in ongoing studies at the HNRCA
  • Willing and able to sign written informed consent prior to study entry
  • iPhone (iOS 11 or higher) user willing to download the COCO application and record food intake for 5 days

You may not qualify if:

  • Android or iPhone (iOs 10 or lower) user unable to download and use the COCO application
  • Holds a graduate degree in nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

  • Wang Y, Beydoun MA. The obesity epidemic in the United States--gender, age, socioeconomic, racial/ethnic, and geographic characteristics: a systematic review and meta-regression analysis. Epidemiol Rev. 2007;29:6-28. doi: 10.1093/epirev/mxm007. Epub 2007 May 17.

    PMID: 17510091BACKGROUND

  • Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

    PMID: 24570244BACKGROUND

  • Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.

    PMID: 19635784BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist and Lab Director

Study Record Dates

First Submitted

September 19, 2018

First Posted

March 11, 2019

Study Start

August 1, 2018

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)