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临床试验/NCT06673342
NCT06673342已完成不适用

Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake: A Pilot Clinical Trial

Loma Linda University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in snacking frequency between baseline and 2 weeks

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Nutritional Counseling (Behavioral)

结局指标

主要结局

Change in snacking frequency between baseline and 2 weeks

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

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.

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

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

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.

次要结局

  • Change in DMFT score between baseline two weeks(Time frame is two weeks: from baseline to the 2 weeks follow-up visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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