Garden-fresh Produce and Exercise Reduce Colon Cancer Risk (GFPE)
2019年6月4日 更新者:William J. McCarthy, Ph.D.、University of California, Los Angeles
Garden-fresh Produce and Exercise Reduce Colon Cancer Risk by Reducing Central Obesity and Increasing Stool Quality
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
California
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Los Angeles、California、美国、90095-6900
- UCLA Center for Cancer Prevention & Control Research
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- body mass index > 25 > 40.
- must reside within 5 miles of the Lincoln Memorial Congregational Church
- must understand English
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Garden-fresh produce and exercise (GFPE)
Participants are encouraged to double their consumption of minimally processed fiber-rich plant foods, especially garden-fresh produce from the church community garden.
Participants are also encouraged to limit pro-inflammatory foods rich in saturated fat, sodium and added sugar.
Participants are also encouraged to engage in 150 minutes of moderate to vigorous physical activity per week, most likely in the form of brisk walking.
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The Garden-fresh produce and exercise (GFPE) health promotion intervention features 10 weekly sessions that take place after Sunday services in the Lincoln Memorial Church kitchen/meeting space.
Each session includes a cooking demonstration focused on how to prepare and cook a meal composed of fiber-rich plant foods minimally processed.
Each session also includes brief, didactic nutrition instruction and a 10-minute bout of physical activity.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Stool weight
大体时间:At baseline and 3 months post-enrollment
|
Mean stool weight of single bowel evacuation using precision digital scale
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At baseline and 3 months post-enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Bristol Stool Chart score
大体时间:At baseline and 3 months post-enrollment
|
Bristol Stool Chart score ranges from 1 (hard lumps) to 7 (soft, diarrhea, liquid)
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At baseline and 3 months post-enrollment
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Waist circumference
大体时间:At baseline and 3 months post-enrollment
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Waist circumference measured over light clothing using tensioner-equipped waist circumference measuring device
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At baseline and 3 months post-enrollment
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Systolic blood pressure
大体时间:At baseline and 3 months post-enrollment
|
Resting blood pressure assessed in participant seated quietly at a table with legs uncrossed
|
At baseline and 3 months post-enrollment
|
Ratio of fruit and vegetable fiber intake to total solid food intake
大体时间:At baseline and 3 months post-enrollment
|
The ratio of fruit and vegetable fiber intake relative to total gram weight of foods consumed per day based on data from Block Food Frequency questionnaire.
|
At baseline and 3 months post-enrollment
|
Saturated fat intake
大体时间:At baseline and 3 months post-enrollment
|
Mean grams (g) of saturated fat intake consumed daily based on retrospective food consumption data obtained from administration of the Block Food Frequency questionnaire.
The Daily Value for saturated fat is less than 20 g per day, based on a 2,000 calorie diet.
Meat-eating Americans generally consume more than 20 g per day but usually don't exceed 80 g per day.
Humans make all the saturated fat that they need, so consuming zero g of saturated fat per day is consistent with good health.
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At baseline and 3 months post-enrollment
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Sugary beverage intake
大体时间:At baseline and 3 months post-enrollment
|
Percent of daily calorie intake attributable to sugary beverage intake
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At baseline and 3 months post-enrollment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年3月17日
初级完成 (预期的)
2019年7月30日
研究完成 (预期的)
2019年8月30日
研究注册日期
首次提交
2019年6月1日
首先提交符合 QC 标准的
2019年6月4日
首次发布 (实际的)
2019年6月6日
研究记录更新
最后更新发布 (实际的)
2019年6月6日
上次提交的符合 QC 标准的更新
2019年6月4日
最后验证
2019年6月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
Because the pilot study sample is small (N=20), the likelihood of deductive disclosure of identity is high even if the shared data were de-identified.
Hence, there will be no sharing of individual level data with other researchers not originally comprising the investigative team.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.