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临床试验/NCT05254496
NCT05254496进行中(未招募)不适用

Ensuring the Cultural Relevance of Dietary Guidelines Diet Patterns Among African Americans: Increasing Dietary Quality and Reducing Type 2 Diabetes Risk (Phase 2)

University of South Carolina1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2022年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
198
试验地点
1
主要终点
Changes in HgbA1c

研究概览

简要总结

Based on the findings of our formative work, conduct a one-year intervention among African American Adults using revised culturally tailored materials to examine differences in Healthy Eating Index (HEI) and type 2 diabetes (T2DM) risk factors among participants (n=198) randomized to one of the 3 dietary patterns:

1) Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern.

详细描述

The U.S. Dietary Guidelines (USDG) form the basis of federal nutrition programs and policy and provide valuable guidance to health initiatives and industries. The updated 2015 USDG moved away from a focus on individual nutrients to a greater focus on dietary patterns. The USDG state that healthy eating goals can be met through a variety of dietary patterns, but present healthy diet in three main ways: 1) Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern. Currently, US adults are falling short of the nutrition recommendations (fruit/vegetable intake, greens/beans, whole grains, etc.) set forth by the USDG and measured by the Healthy Eating Index (HEI). While the USDG are the basis of nutrition guidelines, the research informing these dietary pattern recommendations has largely been drawn from observational studies among mostly white populations. In addition, there has been very limited cultural-tailoring of these dietary patterns that would ensure that these diets are acceptable to diverse populations, in particular, African Americans (AAs) living in the south, who experience a disproportionate burden of chronic disease, especially type 2 diabetes (T2DM). Currently, US adults are not meeting nutrition recommendations (fruit/vegetable, whole grains, etc.) set forth by the USDG and measured by the Healthy Eating Index (HEI).

For this study, AA adult participants with overweight/obesity and ≥three T2DM risk factors will be recruited to participate in the following aim:

Based on the findings of our formative work, conduct a one-year intervention using revised culturally tailored materials to examine differences in HEI and T2DM risk factors among participants (n=198) randomized to one of the 3 dietary patterns. This will result in community-based strategies around presenting dietary guidelines in a way to effectively meet nutrition recommendations leading to significant impacts on health among AA adults.

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
Single (Outcomes Assessor)

盲法说明

Assessors will be blinded to participant group.

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

  • 18-70 years of age
  • BMI between 25- 49.9 kg/m2
  • self-identify as African American
  • live within 150 miles of the Columbia, SC area
  • be able to attend all monitoring visits
  • be willing to be randomized to one of the three conditions
  • be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy

排除标准

  • should not be pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 12 months, or currently breastfeeding
  • o Women who are pregnant should not be pursuing weight loss and should be under the direct care of a physician. Therefore women who are pregnant or who are anticipating they might be pregnant should not participate in this study. If a woman becomes pregnant during the study, she will be advised to consult with her healthcare provider and will be dropped from the weight loss study.
  • should be free of an eating disorder as screened by the Eating disorder Screen for Primary care [ESP]. (If a participant has an eating disorder, they will be given contact information for the eating disorder clinic at the University of South Carolina)
  • no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
  • no recent or planned bariatric surgery
  • no recent weight loss (>10 lbs in the last 6 months)

结局指标

主要结局

Changes in HgbA1c

时间窗: 12 months

Changes in HgbA1c

Changes in dietary quality

时间窗: 12 months

Changes in dietary quality as assessed by the Healthy Eating Index

Changes in body weight

时间窗: 12 months

Changes in body weight

次要结局

  • Changes in blood pressure(12 months)

研究者

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

Brie Turner-McGrievy

Associate Professor

University of South Carolina

研究点 (1)

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