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临床试验/NCT05624775
NCT05624775已完成不适用

Nourishing the Community Through Culinary Medicine

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
Change in Healthy Food Servings by the Nourishing the Community Through Culinary Medicine survey (NCCM)

研究概览

简要总结

The purpose of this study is to adapt existing Nourish Program curriculum for synchronous virtual delivery,to implement adapted virtual Culinary Medicine (CM)curriculum among target population, to assess if program participation improves participant dietary behaviors, nutrition knowledge, and cooking skills and behaviors above standard of care, to assess if program participation improves patient levels of HbA1c, Body Mass Index, Blood Pressure, HDL, LDL and Triglycerides above standard of care and to determine the feasibility and reproducibility of virtual synchronous CM classes in patients with diabetes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 diabetes and glycosylated hemoglobin (HbA1c) >7.0
  • receiving care at Sanitas Medical Center clinics in August 2021 - August 2023
  • English speaking or Spanish speaking.

排除标准

  • Patients without the technological support needed to participate in the program (e.g., reliable internet and device - cell phone, tablet or laptop);
  • Patients with terminal or late-stage conditions (e.g., advanced stage chronic kidney disease);
  • Patients with uncontrolled mental disorder that interferes with participation in active programming;
  • Patients with physical impairment that interferes with participation in active programming

结局指标

主要结局

Change in Healthy Food Servings by the Nourishing the Community Through Culinary Medicine survey (NCCM)

时间窗: Baseline, post intervention (upto 10 weeks after baseline)

This consists of 3 items that are scored from 1 \[None\] to 6 \[4 servings or more\] for a maximum score of 18, a higher number indicating a better outcome.

Change in cooking self-efficacy by the Nourishing the Community Through Culinary Medicine survey (NCCM)

时间窗: Baseline, post intervention (upto 10 weeks after baseline)

This consists of 10 items that are scored from 1 \[Not sure at all\] to 5 \[Extremely sure\], for a maximum of 50, with a higher number indicating more self-efficacy. Five items ask about self-efficacy before the program, and five ask about self-efficacy after the program.

Change in Diabetes Management by the Nourishing the Community Through Culinary Medicine survey (NCCM)

时间窗: Baseline, post intervention (upto 10 weeks after baseline)

This consists of 18 items. The first 16 items that are scored from 1 \[Does not apply to me\] to 4 \[Applies to me very much\] and the remaining 2 items are dichotomous scored \[Yes=1\] to \[No=0\], for a maximum score of 68, with a higher number indicates a better diabetes self-management.

Change in Typical food consumption behaviors by the Nourishing the Community Through Culinary Medicine survey (NCCM)

时间窗: Baseline, post intervention (upto 10 weeks after baseline)

This consists of 7 items that are scored from 1 \[Not at all\] to 5 \[More than once a day\] for a maximum score of 35, a higher number indicating better outcome.

Change in Shopping, cooking, and eating behaviors by the Nourishing the Community Through Culinary Medicine survey (NCCM)

时间窗: Baseline, post intervention (upto 10 weeks after baseline)

This consists of 9 items that are scored from 1 \[Never\] to 5 \[Always\], for a maximum score of 45, with a higher number indicating more ideal shopping, cooking and eating behaviors that align with program goals.

Change in Perceived Barriers to Healthy Eating by the Nourishing the Community Through Culinary Medicine survey (NCCM)

时间窗: Baseline, post intervention (upto 10 weeks after baseline)

This consists of 9 items that are scored from 1 \[Strongly Disagree\] to 5 \[Strongly Agree\] for a maximum score of 45, a higher number indicating more perceived barriers.

次要结局

  • Change in Hemoglobin A1c (HbA1c)(baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM))
  • Change in High-density lipoprotein (HDL)(baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM))
  • Change in systolic Blood Pressure(baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM))
  • Change in low-density lipoprotein (LDL)(baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM))
  • Change in Body Mass Index(baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM))
  • Change in diastolic Blood Pressure(baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM))
  • Change in Triglyceride(baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natalia Heredia

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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