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临床试验/NCT07845383
NCT07845383尚未招募不适用

Bite Sized Biomarkers: Promoting Health Behavior Change Through Objective Dietary Monitoring

Stanford University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
Skin carotenoid scores

研究概览

简要总结

The primary objective of this study is to rigorously evaluate the effectiveness of a Food is Medicine (FIM) intervention using objective biomarkers and to determine the role of nutritional monitoring on the impact and sustainability of integrating nutrition supports into primary care.

详细描述

A critical research gap of FIM is objective, non-invasive measures of dietary intake for rigorously evaluating interventions, such as produce prescription programs. The Veggie Meter® is a research-grade tool strongly correlated with plasma carotenoid levels that utilizes pressure-mediated reflection spectroscopy to rapidly detect carotenoids in the skin, correcting for melanin concentration across skin tones, to estimate V/F intake over 30 days. Carotenoids are fat-soluble compounds found ubiquitously in V/F, detectable in the diet, plasma, and body tissues and may contain bioactive properties that have been demonstrated to slow the progression of chronic disease development. Carotenoid status may serve as a comprehensive, objective, and non-invasive measures of dietary intake that has yet to be implemented in the evaluation of FIM. In addition to being ideally suited for evaluating the effectiveness of FIM, the Veggie Meter® may serve as a promising tool to incorporate into primary care for better assessing dietary intake for prevention and treatment of diet-related chronic diseases. With dietary intake and behavioral lifestyle modifications at the core of chronic disease management, understanding the role of nutritional monitoring in primary care on initiating and sustaining patient health-related behavior change is essential to reduce disease prevalence and severity.

The specific aims of the project are:

Aim 1: Evaluate whether participants in a FIM intervention have higher skin carotenoid scores compared to those not in a FIM intervention over 6 months.

Aim 2: Determine whether informing participants of their skin carotenoid scores at baseline is effective for increasing diet quality at 6 months compared to not receiving skin carotenoid scores. Participants and controls (n=150) will be randomized to receive skin carotenoid scores and their clinical lab values (HbA1c, lipids, BP, anthropometrics) or to only receive their clinical lab values.

Aim 3: Examine barriers and facilitators of integrating objective, non-invasive nutritional monitoring into primary care using a convergent mixed methods design.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
预防
盲法
开放(无盲法)

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

  • adults (18 years or older)
  • at risk for food insecurity (affirmative response to one or more questions on the Huger Vital Signs
  • at risk or experiencing a nutrition-sensitive chronic conditions (e.g., obesity, type 2 diabetes, MASLD, hypertension, etc.)
  • able to read and write in English or Spanish

排除标准

  • planned relocation within the study window
  • currently pregnant or plans to become pregnant within the study window
  • unable to provide informed consent

研究组 & 干预措施

Bite-sized Biomarkers: Knowledge of skin carotenoid scores

Experimental

Participants will be randomized to receive their skin carotenoid scores at baseline.

干预措施: Bite-sized Biomarkers: Skin carotenoid scores (Behavioral)

Bite-sized Biomarkers: Masked to Skin Carotenoid Scores

Active Comparator

Participants will be randomized to be masked to their skin carotenoid values until the follow-up visit.

干预措施: Bite-sized Biomarkers: Skin carotenoid scores (Behavioral)

结局指标

主要结局

Skin carotenoid scores

时间窗: Baseline, 12-weeks, and 6-months.

Change in skin carotenoid scores measured using pressure-mediated reflection spectroscopy (Veggie Meter)

次要结局

  • Dietary Intake(Baseline, 6-months)
  • Depression(Baseline, 6-months)
  • Anxiety(Baseline, 6-month)
  • Food security status(Baseline, 6-months)
  • Nutrition security status(Baseline, 6-months)

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Marcela Radtke

Postdoctoral Research Fellow

Stanford University

研究点 (1)

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标识符

NCT 编号
NCT07845383
其他研究编号
88545, 1K99DK147690-01

日期

首次提交
(9天前)
首次发布
(前天)
主要完成日期
(明年)
研究完成日期
(明年)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否

To protect participant anonymity, individual participant data is not expected to be shared with other researchers.

是否有结果
否

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