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临床试验/NCT05625321
NCT05625321进行中(未招募)不适用

Community-Based Strategies to Reduce Cardiometabolic Disease in the Deep South

University of Alabama at Birmingham4 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2023年3月27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
273
试验地点
4
主要终点
Weight

研究概览

简要总结

The purpose of this study is to promote healthy weight loss among African American women, age 30 or older, who are pre-diabetic and/or have high blood pressure and who live, work, or worship in select rural communities throughout Alabama and Mississippi. The goal of the study is to help reduce the burden of obesity, diabetes, and high blood pressure for these women and to collect information on the reach, effectiveness, adoption, implementation, maintenance, and cost effectiveness of our two evidence-base weight loss programs.

详细描述

This study leverages two evidence-based interventions (EBIs) that have been culturally-adapted for the target population and have previously achieved clinically-relevant weight loss and other clinical outcomes (educational group weight loss intervention) along with improvements in diet and physical activity (home gardening intervention). Combining these EBIs addresses multiple domains (behavioral, personal environment, sociocultural) and levels (individual, interpersonal, community) of influence on risk factors for obesity and other cardiometabolic diseases prevalent in the Deep South. These interventions, delivered by local lay staff and non-academic partners, have a high potential for sustainability; however, there is a need to further evaluate the external validity and implementation-related barriers and facilitators to maximize reach, adoption and implementation. The investigators will employ a pragmatic, multilevel, cluster-randomized, type 1 hybrid effectiveness-implementation trial. A total of 264 Black women (age ≥ 30 years) with overweight or obesity and pre-diabetic or hypertensive from 12 rural counties (6 Alabama, 6 Mississippi) will receive either the combined educational group weight loss intervention plus a home gardening intervention or the educational group weight loss classes alone. The specific aims are to compare interventions on: (1) primary outcomes related to implementation effectiveness (reach, adoption, maintenance of health behaviors), (2) secondary outcomes on clinical effectiveness, and (3) cost effectiveness. Findings will inform discussions with coalition partners to achieve our long-term goal of widely disseminating and sustaining multi-level interventions to reduce the multiple chronic disease burden and health disparities in the Deep South.

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
30 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • self-identifies as Black and/or African American
  • ≥ 30 years old
  • a measured BMI >25 kg/m2 and at least one other cardiometabolic risk factor (physician diagnosis of pre-diabetes and/or hypertension within past 2 years)
  • lives, works, or worships in one of the 12 intervention communities and expresses no intentions to move outside of that community in the 18 months following enrollment
  • a willingness to participate in the study for the 18-months duration.

排除标准

  • being or planning to become pregnant during the 18-month study duration
  • a baseline blood pressure and/or glucose that is outside of the normal range and a medical provider does not provide clearance to participate
  • medical contraindications

结局指标

主要结局

Weight

时间窗: 0, 6, and 12 months

Changes in Weight, measured in pounds

Dietary Intake

时间窗: 0, 6, and 12 months

Changes in diet, measured using a questionnaire

BMI

时间窗: 0, 6, and 12 months

Changes in BMI, calculated as a person's weight in kilograms divided by the square of height in meters

Waist Circumference

时间窗: 0, 6, and 12 months

Changes in waist circumference, measured in centimeters

次要结局

  • Cholesterol Levels(0, 6, and 12 months)
  • Diastolic and Systolic Blood Pressure(0, 6, and 12 months)
  • Fasting Glucose(0, 6, and 12 months)
  • Perceived Quality of Life(0, 6, and 12 months)
  • Physical Activity(0, 6, and 12 months)

研究者

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

Monica L Baskin

Adjunct Professor

University of Alabama at Birmingham

研究点 (4)

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