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临床试验/NCT03976284
NCT03976284Unknown不适用

Garden-fresh Produce and Exercise Reduce Colon Cancer Risk by Reducing Central Obesity and Increasing Stool Quality

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年3月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
21
试验地点
2
主要终点
Stool weight

研究概览

简要总结

The investigators propose a church-based health promotion program designed to reduce colon cancer risk in a mostly African American community served by the Lincoln Memorial Church in South Los Angeles. The investigators propose involving 20 overweight/obese community members in a 10-session health promotion program featuring weekly cooking classes, didactic nutrition instruction and brief bouts of exercise. Behavioral aim is to increase participants' fiber intake from commonly consumed plant foods and reduce their intake of pro-inflammatory foods. They will be followed for 3 months from time of enrollment. Intervention is expected to increase participants' mean stool weight and improve their Bristol Stool Chart score. Intervention is expected to reduce waist circumference and systolic blood pressure of participants. These effects are expected to be accompanied by self-reports of increased fiber intake and reduced intake of saturated fat and refined sugar as well as evidence of increased physical activity.

详细描述

The investigators propose a church-based health promotion program designed to reduce colon cancer risk in a mostly African American community served by the Lincoln Memorial Church in South Los Angeles. The Los Angeles County of Public Health has divided the county into nine service planning areas (SPAs), of which South LA is one. Of all the SPAs, the South LA SPA has the highest prevalence of obesity and the lowest adherence to federal nutrition recommendations. With seed grant funds from a cooperative NIH grant shared by the Drew School of Medicine and University of California-Los Angeles (UCLA), the Lincoln Memorial Church of Los Angeles is sponsoring a behavioral intervention featuring 10 weekly sessions composed of cooking demonstrations, brief didactic nutrition education and 10-minute exercise bouts. All sessions will take place in the church kitchen and meeting room. Participants are expected to be 20 mostly African American, overweight/obese community members. The behavioral goal of the health promotion sessions is to encourage participants to eat more fiber-rich plant foods, minimally processed, to consume fewer pro-inflammatory foods including foods rich in saturated fat, sodium and refined sugar, and to engage in federally recommended amounts of physical activity. If research resources become available to enable blood chemistry results and/or fecal metagenomic results, the investigators would predict that 3 months after participant enrollment in the study, participants would experience a reduction in their high-sensitivity-C-reactive protein concentration and an increase in the relative abundance of obligate anaerobic bacteria relative to other bacteria in fecal samples. As seems likely, however, results will be limited to evaluating the weight and form of participant stool samples using the Bristol Stool Chart and evaluating participants' waist circumference and systolic blood pressure. The 3 month follow-up assessment is expected to show increased stool weight, improved Bristol Stool Chart score, decreased waist circumference, decreased systolic blood pressure, reduced intake of saturated fat and refined sugar, and increased weekly physical activity.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • body mass index > 25 >
  • must reside within 5 miles of the Lincoln Memorial Congregational Church
  • must understand English

排除标准

  • Crohns disease, ulcerative colitis or irritable bowel syndrome
  • currently taking any prescription medication likely to cause weight gain or weight loss
  • Currently taking medication for diabetes (e.g., metformin, insulin)
  • Had a heart attack in the last 12 months
  • Ever had bariatric surgery (weight loss surgery)
  • Have been hospitalized for a mental health problem in the last 12 months
  • Are currently pregnant or breastfeeding
  • Currently use tobacco products such as cigarettes, electronic cigarettes
  • Currently use marijuana products, including edibles

结局指标

主要结局

Stool weight

时间窗: At baseline and 3 months post-enrollment

Mean stool weight of single bowel evacuation using precision digital scale

次要结局

  • Waist circumference(At baseline and 3 months post-enrollment)
  • Systolic blood pressure(At baseline and 3 months post-enrollment)
  • Ratio of fruit and vegetable fiber intake to total solid food intake(At baseline and 3 months post-enrollment)
  • Sugary beverage intake(At baseline and 3 months post-enrollment)
  • Bristol Stool Chart score(At baseline and 3 months post-enrollment)
  • Saturated fat intake(At baseline and 3 months post-enrollment)

研究者

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

William J. McCarthy, Ph.D.

Principal Investigator

University of California, Los Angeles

研究点 (2)

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