Assess Extent of Agreement Between Online 24-hr Dietary Recall and Interviewer-administered 24-hr Dietary Recall on the Same Day for 2 Non-consecutive 2 Days 1 wk Apart to Adults and School Age Children

March 3, 2021 updated by: PepsiCo Global R&D

Cross-sectional Study to Assess the Extent of Agreement Between an Online 24-hr Dietary Recall and an Interviewer-administered 24-hr Dietary Recall on the Same Day for 2 Non-consecutive Days 1 wk Apart to Adults and School Age Children in Order to Compare Energy and Nutrient Intakes Derived From the Two Methods and Conduct User Evaluation of the Online Dietary Assessment Tool

Hypothesis: The online 24 hour dietary recall will be comparable to interviewer-administered 24 hour dietary recall considering the limits of agreement in the reporting of energy and macronutrient intake. If the two methods of dietary assessment are comparable (i.e., if greater than 95% of the data plots will lie within the limits of agreement), the online dietary assessment tool could be used in future studies to collect dietary intake data and health data in larger sets of Russian populations, in order to investigate the potential differences in anthropometric risk factors of non-communicable diseases (cancers, diabetes, obesity, hypertension, mortality, etc.) in people with different diet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Baseline assessments include a demographic questionnaire, including anthropometrics (height, weight), a heath status questionnaire, supplement intake, eating habits, and a food frequency questionnaire, and cardiovascular assessment (blood pressure and heart rate).

Study Type

Observational

Enrollment (Actual)

204

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

  • Russian Federation
      • Saint Petersburg, Russian Federation, 191014
        • CRO Name: OCT Rus Ltd.
      • Saint Petersburg, Russian Federation, 196143
        • Eco-Safety LLC
      • Saint Petersburg, Russian Federation, 199226
        • Astarta, LCC
      • Saint Petersburg, Russian Federation, 199406
        • Mayly LLC

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

7 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recruited at 3 locations within a specific area: Saint-Petersbourg Russia

Description

Inclusion Criteria:

  1. Participants will be male and female.
  2. 7-65 years of age.
  3. Must be willing and able to record (via online questionnaire) the prior day's food intake according to the protocol.
  4. Understanding of the procedures to be undertaken as part of the study.
  5. Willingness to participate in research measurement and follow instructions provided by the investigator.
  6. Informed, voluntary, written consent to participate in the study.

Exclusion Criteria:

  1. Currently have any disease or condition that required chronic therapeutic nutritional treatment (the use of specific nutrition services to treat an illness, injury, or condition).
  2. Currently dieting (currently on a diet to lose weight; currently on a diet for health reasons; currently on a diet to gain weight).
  3. Have any formal training in nutrition, or had prior experience completing dietary recalls.
  4. Participant is unable to complete computer-based dietary questionnaires, through a mental, physical or visual limitation that would preclude him/her from reporting their dietary intake.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Younger school age children
Equal ratio of boys and girls, age range 7-13 years (68 subjects)
Other: Dietary assessment
24-hr dietary recall
Older school age children
Equal ratio of boys and girls), age range 14-17 years (68 subjects)
Other: Dietary assessment
24-hr dietary recall
Adults
Equal ratio of adult men and women, age range 18-65 years (68 subjects).
Other: Dietary assessment
24-hr dietary recall

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of agreement between online self-administered online 24 hour dietary recall and interviewer-administered 24 hour dietary recall in energy and nutrient reporting
Time Frame: The average of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Bland Altman analysis of energy and macronutrient (carbohydrates, fat, protein) intake. Data for adults, younger school age children (7-13 years) and older school age children (14-17 years) participants in different age subgroups (7-13 years, 14-17 years, 18 years and older) will be analyzed separately.
The average of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between the self-administered online 24 hour dietary recall and the interviewer-administered 24 hour dietary recall in the reporting of energy and nutrient intake.
Time Frame: The average of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Absolute and percent difference. Data for adults, younger school age children (7-13 years) and older school age children (14-17 years) participants in different age subgroups (7-13 years, 14-17 years, 18 years and older) will be analyzed separately.
The average of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Correlation between estimates of energy and nutrient intake reported by self-administered online 24 hour dietary recall and the interviewer-administered 24 hour dietary recall for the same day.
Time Frame: The average of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Cross-classification analysis. Data for adults, younger school age children (7-13 years) and older school age children (14-17 years) participants in different age subgroups (7-13 years, 14-17 years, 18 years and older) will be analyzed separately. The relative agreement will be in quartiles: exact agreement, exact plus adjacent quartile, disagreement or extreme disagreement.
The average of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Extent of agreement between measured and self-reported body mass index (BMI)
Time Frame: The average body mass index (BMI) in kg/m squared of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Bland Altman analysis. Data for adults, younger school age children (7-13 years) and older school age children (14-17 years) participants in different age subgroups (7-13 years, 14-17 years, 18 years and older) will be analyzed separately.
The average body mass index (BMI) in kg/m squared of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Extent of agreement between measured and self-reported weight
Time Frame: The average weight in kg of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Bland Altman analysis. Data for adults, younger school age children (7-13 years) and older school age children (14-17 years) participants in different age subgroups (7-13 years, 14-17 years, 18 years and older) will be analyzed separately.
The average weight in kg of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Extent of agreement between measured and self-reported height
Time Frame: The average height in cm of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
Bland Altman analysis. Data for adults, younger school age children (7-13 years) and older school age children (14-17 years) participants in different age subgroups (7-13 years, 14-17 years, 18 years and older) will be analyzed separately.
The average height in cm of the two 24 hour periods (recall 1 and recall 2) within each method. Recall 1 and Recall 2 are in-person visits one week apart.
User acceptability of the online dietary assessment tool based on the evaluation questionnaire data
Time Frame: At the conclusion of the second in-person visit, one week after the first in-person visit.
Evaluation questionnaire. Data for adults, younger school age children (7-13 years) and older school age children (14-17 years) participants in different age subgroups (7-13 years, 14-17 years, 18 years and older) will be analyzed separately.
At the conclusion of the second in-person visit, one week after the first in-person visit.

Collaborators and Investigators

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

Sponsor

PepsiCo Global R&D

Investigators

  • Study Director: Mariya Soshina, PepsiCo Holdings, LLC 72/4, Leningradsky prospect, Moscow, Russian Federation, 125315

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 (ACTUAL)

February 19, 2020

Primary Completion (ACTUAL)

October 26, 2020

Study Completion (ACTUAL)

October 26, 2020

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (ACTUAL)

May 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEP-1803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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