Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake

NCT06673342 | Completed

• 1 other identifier: 5240464
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the effectiveness of nutritional counselling on added sugar consumption, frequency of snacking and caries experiences expressed as Decayed, Missing, and Filled Teeth score (DMFT).

Conditions

Dental Cavity; Caries,Dental

Keywords

Sugar Consumption; Nutritional Counselling

Outcome Measures

Primary Outcomes (2)

• Change in snacking frequency between baseline and 2 weeks

  Subjects will self-report the snacking frequency per day at baseline and at 2 weeks. Snacking is defined as any food intake besides breakfast, lunch and dinner.

  Time frame is two weeks: from baseline to the 2 weeks follow-up visit

• Change in amount of added sugar consumption during snacking between baseline and 2 weeks.

  Added sugar consumption will be calculated using the "Sugar intake calculator" app at baseline and at 2 weeks follow-up. The sugar intake calculator is a free app that can generate the amount of added sugar in snacks, providing the amount in grams. Subjects will self-report the snacks that they have been consuming. The added sugar threshold for cavities is set at 40 gram/day.

  Time frame is two weeks: from baseline to the 2 weeks follow-up visit

Secondary Outcomes (1)

• Change in DMFT score between baseline two weeks

  Time frame is two weeks: from baseline to the 2 weeks follow-up visit

Study Arms (2)

Control

NO INTERVENTION

Visual assessment of DMFT, added sugar consumption calculation, frequency of snacking calculation.

Intervention

EXPERIMENTAL

Visual assessment of DMFT, added sugar consumption calculation, frequency of snacking calculation, plus Stephan's Curve-based nutritional counseling.

Behavioral: Nutritional Counseling

Interventions

Nutritional Counseling BEHAVIORAL

Nutritional counseling based on Stephan's Curve. The Stephan's curve is a diagram that shows how the acidity of the oral cavity changes with consumption of food, specifically with added sugar. A laminated Stephan's curve will be used to show the drop of pH (acidity) based on the subject's reported daily consumption of food and snacks. Recommendations will be provided on a balanced diet according to the American Dental Association guidelines and recommendations on reducing the frequency of snacking.

Also known as: Stephan's Curve

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are 18 years or older
• Subjects who will comply with study protocol
• Subjects who can read and speak English
• Subjects available during the study period

You may not qualify if:

• Subjects under the age of 18
• Subjects have less than 20 teeth

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• So Ran Kwon, DDS, MS, PhD, MS

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A convenience sample of 100 participants will be enrolled for the study. Selection of participants will concur to a written consent primarily based on voluntary agreement. For each participant the following procedures will be performed: 1. Record a thorough health history from each subject regarding past and present family health conditions and demographic information including demographic information, including age, gender, and race/ethnicity. 2. For the control group an oral examination to visually assess the DMFT scores will be performed and added sugar consumption will be calculated using the online application, "Sugar Intake Calculator", with no additional nutritional counseling tool utilized. 3. For the intervention group, an oral examination to visually assess the DMFT scores will be performed and added sugar consumption will be calculated using the online application, "Sugar Intake Calculator", with the intervention of Stephan's curve as a nutritional tool.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 13, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)