Clinical trial NCT04372160: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Habits
Keywords: 24-hr dietary recall
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2020-05-01
Enrollment: 204
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruited at 3 locations within a specific area: Saint-Petersbourg Russia

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Extent of agreement between online self-administered online 24 hour dietary recall and interviewer-administered 24 hour dietary recall in energy and nutrient reporting
timeFrame: 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:
measure: 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.
timeFrame: 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.
measure: 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.
timeFrame: 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.
measure: Extent of agreement between measured and self-reported body mass index (BMI)
timeFrame: 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.
measure: Extent of agreement between measured and self-reported weight
timeFrame: 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.
measure: Extent of agreement between measured and self-reported height
timeFrame: 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.
measure: User acceptability of the online dietary assessment tool based on the evaluation questionnaire data
timeFrame: At the conclusion of the second in-person visit, one week after the first in-person visit.
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: CRO Name: OCT Rus Ltd.
city: Saint Petersburg
country: Russian Federation
facility: Eco-Safety LLC
city: Saint Petersburg
country: Russian Federation
facility: Astarta, LCC
city: Saint Petersburg
country: Russian Federation
facility: Mayly LLC
Study officials:
affiliation: PepsiCo Holdings, LLC 72/4, Leningradsky prospect, Moscow, Russian Federation, 125315
name: Mariya Soshina
role: STUDY_DIRECTOR
References: