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

Dietary Habits Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372160
• Other study ID #: PEP-1803
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: October 26, 2020

Study information

• Verified date: March 2021
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 26, 2020
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Habits

Intervention

Other:
• Dietary assessment
24-hr dietary recall

Locations

Country	Name	City	State
Russian Federation	Astarta, LCC	Saint Petersburg
Russian Federation	CRO Name: OCT Rus Ltd.	Saint Petersburg
Russian Federation	Eco-Safety LLC	Saint Petersburg
Russian Federation	Mayly LLC	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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.
Secondary	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.	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.
Secondary	Extent of agreement between measured and self-reported body mass index (BMI)	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.
Secondary	Extent of agreement between measured and self-reported weight	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.
Secondary	Extent of agreement between measured and self-reported height	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.
Secondary	User acceptability of the online dietary assessment tool based on the evaluation questionnaire data	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.