NCT04372160

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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

February 19, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2020

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

April 28, 2020

Last Update Submit

March 3, 2021

Conditions

Keywords

24-hr dietary recall

Outcome Measures

Primary Outcomes (1)

  • Extent of agreement between online self-administered online 24 hour dietary recall and interviewer-administered 24 hour dietary recall in energy and nutrient reporting

    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 Outcomes (6)

  • 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.

    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.

    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)

    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

    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

    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.

  • +1 more secondary outcomes

Study Arms (3)

Younger school age children

Equal ratio of boys and girls, age range 7-13 years (68 subjects)

Other: Dietary assessment

Older school age children

Equal ratio of boys and girls), age range 14-17 years (68 subjects)

Other: Dietary assessment

Adults

Equal ratio of adult men and women, age range 18-65 years (68 subjects).

Other: Dietary assessment

Interventions

24-hr dietary recall

AdultsOlder school age childrenYounger school age children

Eligibility Criteria

Age7 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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).
  • Currently dieting (currently on a diet to lose weight; currently on a diet for health reasons; currently on a diet to gain weight).
  • Have any formal training in nutrition, or had prior experience completing dietary recalls.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CRO Name: OCT Rus Ltd.

Saint Petersburg, 191014, Russia

Location

Eco-Safety LLC

Saint Petersburg, 196143, Russia

Location

Astarta, LCC

Saint Petersburg, 199226, Russia

Location

Mayly LLC

Saint Petersburg, 199406, Russia

Location

Related Publications (1)

  • Pigat S, Soshina M, Berezhnaya Y, Kryzhanovskaya E. Web-Based 24-Hour Dietary Recall Tool for Russian Adults and School-Aged Children: Validation Study. JMIR Form Res. 2023 Aug 16;7:e41774. doi: 10.2196/41774.

MeSH Terms

Conditions

Feeding Behavior

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Mariya Soshina

    PepsiCo Holdings, LLC 72/4, Leningradsky prospect, Moscow, Russian Federation, 125315

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 1, 2020

Study Start

February 19, 2020

Primary Completion

October 26, 2020

Study Completion

October 26, 2020

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations