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临床试验/NCT04528615
NCT04528615已完成不适用

A Randomized Controlled Trial to Test the Effectiveness of Coping With Cancer in the Kitchen, a Nutrition Education Program From Diagnosis and Beyond

American Institute for Cancer Research1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2019年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
Confidence preparing a variety of plant-based foods

研究概览

简要总结

The study was a two-arm, randomized controlled trial in which cancer survivors were evenly assigned to either receive the 8-week CCK in-person nutrition intervention immediately or to become the control group that received a selection of CCK printed materials. The aim was to test the effectiveness of CCK for implementing a healthy plant-based diet and improving quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
是

入选标准

  • 未提供

排除标准

  • •Need to have ever been diagnosed with cancer to be eligible
  • •Need to have not participated in a Living Plate cooking program
  • •Need to be able to attend at least seven of the eight sessions of the series with mandatory first and last sessions
  • •Need to have completed active cancer treatment (not including hormonal or other similar agents, e.g., tamoxifen)

研究组 & 干预措施

CCK Printed Materials

Active Comparator

This group received select printed CCK materials.

干预措施: CCK Printed Materials (Behavioral)

CCK In-Person Sessions

Experimental

This group received the in-person CCK intervention.

干预措施: CCK In-Person Sessions (Behavioral)

结局指标

主要结局

Confidence preparing a variety of plant-based foods

时间窗: 15 weeks

Change from baseline in confidence to prepare a variety of plant-based foods. Participants indicated "How sure are you that you could prepare the foods listed below in a tasty way?" (1 = Very unsure; 5 = Very sure). The 14-item scale included: 4 whole grains; 4 beans, seeds and legumes; 3 green leafy vegetables; and 3 mixed foods, e.g. healthy one-pot meals. A composite score was calculated as the average of the 14 items (range 1-5; Cronbach's alpha=.75).

Skills to practice a plant-based diet

时间窗: 15 weeks

Change from baseline in skills to practice a plant-based diet. Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with five custom items developed by the research team, e.g., "I am confident that I can create a kitchen environment that makes it easier to store, prepare, and consume fruits, vegetables, whole grains, and beans."; the average of the five ratings was calculated to create a skills composite score (range 1-5; Cronbach's alpha=.88).

Knowledge about the role of a plant-based diet in cancer risk reduction

时间窗: 15 weeks

Change from baseline in knowledge about role of consuming a predominantly plant-based diet and cancer risk. Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with six custom items developed by the research team, e.g., "I understand the benefits of consuming whole grains versus processed grains". A composite score was calculated as the average of the 6 ratings (range 1-5; Cronbach's alpha=.80).

Barriers to eating more fruits and vegetables and whole grains

时间窗: 15 weeks

Change from baseline in barriers to eating more fruits and vegetables. We adapted items from an existing barriers instrument to measure perceived barriers to eating more fruits and vegetables (F\&V) (average score of 15 items; Cronbach's alpha = .89) and whole grains (average score of 14 items; Cronbach's alpha = .83). Participants were asked the general question, "Listed below are some common reasons why people don't eat more servings of vegetables and fruits each day. Indicate whether or not this is a reason for you by marking how much you agree or disagree." (1 = Strongly disagree; 5 = Strongly agree). In addition, using the same list of possible reasons (excluding spoil too quickly), participants indicated whether it was a common reason they didn't eat more servings of whole grains. Example reasons included: take too much time to prepare; my family doesn't like them; hard to find a variety of good ones.

Knowledge about the role of a plant-based diet in cancer risk reduction

时间窗: 9 weeks

Change from baseline in knowledge about role of consuming a predominantly plant-based diet and cancer risk. Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with six custom items developed by the research team, e.g., "I understand the benefits of consuming whole grains versus processed grains". A composite score was calculated as the average of the 6 ratings (range 1-5; Cronbach's alpha=.80).

Confidence preparing a variety of plant-based foods

时间窗: 9 weeks

Change from baseline in confidence to prepare a variety of plant-based foods. Participants indicated "How sure are you that you could prepare the foods listed below in a tasty way?" (1 = Very unsure; 5 = Very sure). The 14-item scale included: 4 whole grains; 4 beans, seeds and legumes; 3 green leafy vegetables; and 3 mixed foods, e.g. healthy one-pot meals. A composite score was calculated as the average of the 14 items (range 1-5; Cronbach's alpha=.75).

Skills to practice a plant-based diet

时间窗: 9 weeks

Change from baseline in skills to practice a plant-based diet. Participants rated their agreement (1 = Strongly disagree; 5 = Strongly agree) with five custom items developed by the research team, e.g., "I am confident that I can create a kitchen environment that makes it easier to store, prepare, and consume fruits, vegetables, whole grains, and beans."; the average of the five ratings was calculated to create a skills composite score (range 1-5; Cronbach's alpha=.88).

Barriers to eating more fruits and vegetables and whole grains

时间窗: 9 weeks

Change from baseline in barriers to eating more fruits and vegetables and whole grains. We adapted items from an existing barriers instrument to measure perceived barriers to eating more fruits and vegetables (F\&V) (average score of 15 items; Cronbach's alpha = .89) and whole grains (average score of 14 items; Cronbach's alpha = .83). Participants were asked the general question, "Listed below are some common reasons why people don't eat more servings of vegetables and fruits each day. Indicate whether or not this is a reason for you by marking how much you agree or disagree." (1 = Strongly disagree; 5 = Strongly agree). In addition, using the same list of possible reasons (excluding spoil too quickly), participants indicated whether it was a common reason they didn't eat more servings of whole grains. Example reasons included: take too much time to prepare; my family doesn't like them; hard to find a variety of good ones.

次要结局

未报告次要终点

研究者

发起方
American Institute for Cancer Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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