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

Completed

• Conditions: Dietary Habits
• Interventions: Other: Dietary assessment

• Registration Number: NCT04372160
• Lead Sponsor: PepsiCo Global R&D

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).

Study Timeline

• Study Start: 2020-02-19
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-01
• Primary Completion: 2020-10-26
• Study Completion: 2020-10-26
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Younger school age children	Dietary assessment	Equal ratio of boys and girls, age range 7-13 years (68 subjects)
Older school age children	Dietary assessment	Equal ratio of boys and girls), age range 14-17 years (68 subjects)
Adults	Dietary assessment	Equal ratio of adult men and women, age range 18-65 years (68 subjects).

Primary Outcome Measures

Name	Time	Method
Extent of agreement between online self-administered online 24 hour dietary recall and interviewer-administered 24 hour dietary recall in energy and nutrient reporting	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
User acceptability of the online dietary assessment tool based on the evaluation questionnaire data	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.

Trial Locations

Locations (4)

Astarta, LCC; 🇷🇺 Saint Petersburg, Russian Federation

Mayly LLC; 🇷🇺 Saint Petersburg, Russian Federation

Eco-Safety LLC; 🇷🇺 Saint Petersburg, Russian Federation

CRO Name: OCT Rus Ltd.; 🇷🇺 Saint Petersburg, Russian Federation