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临床试验/NCT04052815
NCT04052815Unknown不适用

Culturally Adapted Community-based Translational Diabetes Prevention Program for Obese and Pre-diabetic Hispanic/Latino Females

Loyola University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Change from Baseline waist circumference at 12 months

研究概览

简要总结

Is well known that obesity is increasing in the United States (US) and particularly among Hispanic/ especially in in socially disadvantaged groups. Studies have shown that the prevalence of metabolic syndrome is about 1.5 times higher among Mexican American females living in the US compared to non-Hispanic females. Culturally among Hispanic/Latino females some activities like grocery shopping and meal cooking in households that most likely impact other family members.

Culturally grounded interventions can be made readily tailored and translated into real-world settings by utilizing collaborative, community based participatory approaches. The overall objective of this study is to offer a diabetes prevention program to the community, targeting adult females with Hispanic/Latino background population that could benefit from a sustainable change behavior program to reduce the risk of developing Type 2 Diabetes, metabolic syndrome and cardiovascular disease. Sessions will be conducted in Spanish or English according to participants' preferences. The program format is to meet for one year. Cadence will be once a week for the next 16 weeks (Core curriculum), then once a month (maintenance curriculum). In addition to the DPP curriculum a structured physical activity component will be added, with the objective of facilitating achievement of program goals. Other culturally tailored activities will be included like: grocery shopping, recipes community walking maps and other available community resources.

In addition the investigators will utilize a qualitative approach to gather information about project's feasibility and acceptability. To do so, investigators plan to conduct 60 minutes focus groups and semi structured interviews at the end of the 16 week core-program and at the end of the program (program participants and staff members).

详细描述

Is well known that obesity is increasing in the United States (US) and particularly among Hispanic/Latinos and African American women especially in in socially disadvantaged groups. Similarly, diabetes mellitus is a health care burden in the US, with associated costs estimated in $174 billion in 2007, and projections for 2030 estimate that about 30 million Americans will have diabetes. Studies have shown that the prevalence of metabolic syndrome is about 1.5 times higher among Mexican American females living in the US compared to non-Hispanic females.

Latinos is one of the largest ethnic groups in the Chicago metropolitan region, in Cook county they comprise about 25% of the population (around 1,295,000 people), and of those 75% are of Mexican origin followed by Puerto Rican (13%).

In addition 17% of the population in Chicagoland area does not count with health insurance, the Latino community having the higher percent of uninsured population ranging from 18-32%. This puts in disadvantage the Hispanic/Latino population with high risk factors to develop chronic diseases that have proven to be more prevalent amongst them, like T2D and metabolic syndrome. Culturally among Hispanic/Latino females some activities like grocery shopping and meal cooking in households that most likely impact other family members.

Culturally grounded interventions can be made readily tailored and translated into real-world settings by utilizing collaborative, community based participatory approaches. From a public health perspective, these approaches may offer the greater likelihood for closing the obesity related health disparities gap that currently exist among community members in the US population.

The Diabetes Prevention Program (DPP), a randomized controlled trial of a lifestyle change program implemented from 1996 through 2002 with up to 5 years of follow up, demonstrated that individuals with prediabetes who achieved between 5-7% weight reduction and participated in regularly physical activity reduced their T2D risk between 58-71%, twice that achieved through medication. Specifically the DPP program has two main goals: weight loss through healthy eating, aiming for 5-7%; and regular physical activity (PA) to improve overall health, aiming for 150 minutes of brisk PA per week. The program is delivered over a year by DPP trained lifestyle coaches.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Hispanic/Latino background, female, ≥18 years old, with Body mass index (BMI) ≥25 or Glycated hemoglobin (Hb1AC) and/or glucose on parameter to be considered pre-diabetic.

排除标准

  • to have a diagnosis of diabetes, taking medication for diabetes, conditions that impedes mobilization, mental impairment, or conditions that impede to be under diet restrictions.

结局指标

主要结局

Change from Baseline waist circumference at 12 months

时间窗: 12 months

waist circumference in centimeters

Change from Baseline Glycated hemoglobin at 12 months

时间窗: 12 months

Glycated hemoglobin (HbA1C)

Change from Baseline Weight at 12 month

时间窗: 12 months

weight in lb

次要结局

  • Change from Baseline low density lipoprotein (LDL) at 12 months(12 months)
  • Change from baseline High-density lipoprotein (HDL) at 12 months(12 months)
  • Dietary assessment for fruits and vegetables(baseline, 16 weeks, 12 months)
  • Dietary assessment of fat consumption(baseline, 16 weeks, 12 months)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nallely Mora

Research Assistant Professor

Loyola University

研究点 (2)

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