Clinical trial NCT06673342: Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake
Official title: Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Cavity
Caries,Dental
Keywords: Sugar Consumption
Nutritional Counselling
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

Detailed description: The study involves two visits: the first lasting approximately 30-45 minutes, and the second about 15 minutes that occurs 2 weeks after the first visit.

Procedures and Activities. Subjects will be assigned to either the control or intervention group by the toss of a coin. Subjects will provide information about their personal health history, including age, gender, and race/ethnicity. Subjects will undergo an oral examination to assess dental health through a DMFT score, which measures decayed, missing, and filled teeth. Additionally, the daily added sugar consumption will be calculated using an app called "Sugar Intake calculator." For the control group, no further nutritional advice will be given, while participants in the intervention group will receive additional guidance on sugar consumption using a tool called Stephan's curve. A log will be given to the subjects to track their daily snacking frequency and what type and amount of snack it entailed. After two weeks, subjects will return for a follow-up to evaluate any changes in dental health, sugar consumption, and snacking habits.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in snacking frequency between baseline and 2 weeks
timeFrame: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
measure: Change in amount of added sugar consumption during snacking between baseline and 2 weeks.
timeFrame: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
Secondary outcomes:
measure: Change in DMFT score between baseline two weeks
timeFrame: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University
name: So Ran Kwon, DDS, MS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: